Member Update FUTURE MEETINGS: June 25-28, 2009 at Chicago Marriott Downtown, Miracle Mile, Chicago, Illinois January 14-17, 2010 at Tampa Marriott Waterside, Tampa, FL June 17-20, 2010 at Loews Philadelphia Hotel, Philadelphia, PA DATE: July 2, 2009 SUBJECT: RTOG 0828, Amended: Amendment # added to cover page Attention investigators for RTOG 0828: The amendment number (Amendment 1) was added to the cover page of the amended protocol that was broadcast on Tuesday, June 30. It was inadvertently left off of the page at the initial broadcast. The protocol is available on the RTOG web site at http://www.rtog.org/members/protocols/0828/0828.pdf RTOG apologizes for any confusion. DATE: July 2, 2009 SUBJECT: RTOG 0612, Updated Updated RTOG 0612, "Investigating Markers of Radiation Outcome in Patients With Intermediate-Risk Prostate Cancer Using DNA Microarray Analysis: An RTOG Pilot Study" Sections 10.0, 12.0, and Appendix II were updated with the RTOG Biospecimen Resource name and contact information. Sites can access the complete summary of changes at http://www.rtog.org/members/protocols/0612/summary_changes.html Sites can download a copy of the updated protocol by accessing the RTOG web site at http://www.rtog.org/members/protocols/0612/0612.pdf The "Update Date" on the protocol title page indicates that editorial/administrative changes were made to the protocol. For clarity, the broadcast date of the update is provided in parentheses on the summary of changes document. IRB review of an update is not required; however, these changes must be reported to site IRBs. Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: July 1, 2009 SUBJECT: RTOG (0411), 0417,(0615), (0625), & 0825 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety report(s) from NCI for BEVACIZUMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by the NCI. The Following RTOG studies involve BEVACIZUMAB: RTOG (0411), "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417, "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG (0615), "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG (0625), "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" RTOG 0825, "Phase III Double-Blind Placebo-Controlled Trial of Conventional Concurrent Chemoradiation and Adjuvant Temozolomide Plus Bevacizumab Versus Conventional Concurrent Chemoradiation and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - Bevacizumab, AE-1687519, Protocol S0518, -ISR.pdf - Bevacizumab Epothilone B Analog, AE-1839475, Protocol CALGB-40502, - ISR.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: July 1, 2009 SUBJECT: RTOG Registration Desk Closure The RTOG Registration Desk will be closed for the July 4th holiday on Thursday, July 2nd at 3 p.m. EST and will remain closed Friday, July 3rd.  We will reopen on Monday, July 6th at 8:30 a.m. EST.  Sites may access web registration 24/7. Please notify your affiliates that are not on e-mail. DATE: July 1, 2009 SUBJECT: RTOG 0513, Closure Notice Closure Notice RTOG 0513, "A Phase I/II Trial of Temozolomide, Motexafin Gadolinium, and 60 Gy Fractionated Radiation for Newly Diagnosed Supratentorial Glioblastoma Multiforme," will close to patient accrual at 5 PM EST today, Wednesday, July 1, because the study has met its accrual objective. (Notice of this closure was previously broadcast on 6/17/09.) Please notify your affiliates who are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, please e-mail mbuado@acr-arrs.org. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. DATE: June 30, 2009 SUBJECT: Web-Based Electronic Submission Update - RTOG 0813 Web-Based Electronic Data Submission is now available for the following RTOG LUNG study form: RTOG 0813 F1 Follow Up Form SEAMLESS PHASE I/II STUDY OF STEREOTACTIC LUNG RADIOTHERAPY FOR EARLY STAGE, CENTRALLY LOCATED NON-SMALL CELL LUNG CANCER (NSCLC) IN MEDICALLY INOPERABLE PATIENTS Per previous Broadcasts, web-based data submission became mandatory as of May 14, 2007 for all forms available for web-entry for all cases enrolled through RTOG. A complete listing of forms available for web data submission is available at http://www.rtog.org/members/webreg.html For technical support with web data submission, please email websupport@acr-arrs.org Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214. All follow up forms received in paper format after July 1, 2009 will be returned to the site for transcription. Please notify your joint center institutions and affiliates who are not on e-mail. Mary Gramkowski, RN, BA, CCRP DATE: June 30, 2009 SUBJECT: RTOG 0828, Amended Amended RTOG 0828, "Pilot Project to Reduce Missing RTOG Quality of Life Data via Electronic Web-Based Form Collection: A Companion Study for RTOG 0415 (A Phase III Randomized Study of Hypofractionated 3D-CRT/IMRT Versus Conventionally Fractionated 3D-CRT/IMRT in Patients With Favorable-Risk Prostate Cancer)," Amendment #1: The sample size was reduced from 100 to 40 patients, and the list of participating institutions was updated. Sites can access the complete summary of changes at http://www.rtog.org/members/protocols/0828/summary_changes.html Sites can download a copy of the amended protocol by accessing the RTOG web site at http://www.rtog.org/members/protocols/0828/0828.pdf The "Version Date" on the protocol title page reflects the date the amendment was finalized at RTOG Headquarters; for clarity, the broadcast date is provided in parentheses. Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. Note: This is a limited-institution study open only to institutions accruing to RTOG 0415 that are noted on the RTOG 0828 cover page. Please notify your affiliates that are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, please e-mail mbuado@acr-arrs.org. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. DATE: June 25, 2009 SUBJECT: RTOG eNews: Revised - RTOG Semiannual Symposium & Keynote Address RTOG eNews June 25, 2009 RTOG Semiannual Meeting Symposium: Globalization of RTOG Research Programs Friday, June 26, 2009, 9:00 - Noon Introduction Walter J. Curran, Jr., MD, RTOG Group Chair, Emory University NCI Perspective Ted Trimble, MD, MPH, National Cancer Institute Pharmacogenetics of Cancer Suresh S. Ramalingam, MD, Emory University Corey J. Langer, MD, University of Pennsylvania RTOG Perspective - Full Member PI Perspective, Challenges in Mentoring Elizabeth Gore, MD, Medical College of Wisconsin - International Member - Becoming an RTOG Member Benjamin W. Corn, MD, Tel Aviv Sourasky Medical Center - Canadian Experience Michael Goodyear, BMedSC MBBS, Dalhousie University - RTOG/EORTC Collaboration Wilma Hoffman, RN, BSN, RTOG Senior Director - RTQA & Technology Assessment James M. Galvin, DSc, Thomas Jefferson University James A. Deye, PhD, National Cancer Institute Quality of Life-Multicultural Perspective Benjamin Movsas, MD, Henry Ford Health System Panel Discussion & Summary Mohan Suntharalingham, MD, RTOG Vice Chair Membership, University of Maryland Plenary Session - Keynote Address Saturday, June 27, 2009 Global Trends in Oncology Otis W. Brawley, MD, Chief Medical Officer, American Cancer Society Contact Us If you need further information or wish to be added to or removed from our mailing list please send an e-mail to shartson@acr-arrs.org. RTOG's clinical trials are available at http://www.rtog.org/members/active.html. More information is available on the Web at www.rtog.org DATE: June 24, 2009 SUBJECT: RTOG 0873 (NCIC CTG PR.11) - START RTOG 0873, "A Phase III Study of Active Surveillance Therapy Against Radical Treatment in Patients Diagnosed With Favourable Risk Prostate Cancer (START)" TO: RTOG sites participating in RTOG 0873 (NCIC CTG PR.11) FROM: Andrea Hiltz, Study Coordinator SUBJECT: START trial website I am pleased to announce that the START trial Internet site is now "live" on the world wide web! The website can be accessed at www.startstudy.ca and includes: Information for both patients and physicians about clinical trials, the START trial and the NCIC CTG Link to view the patient educational video A "centre finder" for interested participants An option to "tell a friend" about the trial Links to the official trial website (password protected) If you have any comments or questions about the website or wish to make some suggestions for interesting links and/or FAQs, please do not hesitate to contact me. Thank you for your continued support of our trial. Sincerely, Andrea Hiltz RTOG 0873/PR.11 Study Coordinator Phone: 613-533-6430 Fax: 613-533-2941 DATE: June 24, 2009 SUBJECT: RTOG 0619, Amended Amended RTOG 0619, "A Randomized Phase II Trial of Chemoradiotherapy Versus Chemoradiotherapy and Vandetanib for High-Risk Postoperative Advanced Squamous Cell Carcinoma of the Head And Neck", Amendment 1: The required EKGs were clarified, and sections were amended at the request of Astra-Zeneca. Sites can access the complete summary of changes at http://www.rtog.org/members/protocols/0619/summary_changes.html Sites can download a copy of the amended protocol by accessing the RTOG web site at http://www.rtog.org/members/protocols/0619/0619.pdf In addition, a summary of the EKGs required in this study is available on the RTOG web site at http://www.rtog.org/members/protocols/0619/0619%20EKG%20Summary.doc NCI policy requires that the "Version Date" on the protocol title page reflect the date the amendment was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses. Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. If an amendment involves changes to the risks section of the consent, RTOG recommends re-consenting patients on the trial; however, your local IRB will have the final authority. Please notify your affiliates that are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, please e-mail mbuado@acr-arrs.org. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. DATE: June 23, 2009 SUBJECT: RTOG (0411), 0417,(0615), (0625), & 0825 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety report(s) from NCI for BEVACIZUMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by the NCI. Per NCI - Please note the following FOLLOW-UP information:  BASED UPON FURTHER INVESTIGATION, THIS ADVERSE EVENT IS CONSIDERED UNRELATED/UNLIKELY RELATED TO THE INVESTIGATIONAL AGENT/THERAPY. The Following RTOG studies involve BEVACIZUMAB: RTOG (0411), "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417, "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG (0615), "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG (0625), "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" RTOG 0825, "Phase III Double-Blind Placebo-Controlled Trial of Conventional Concurrent Chemoradiation and Adjuvant Temozolomide Plus Bevacizumab Versus Conventional Concurrent Chemoradiation and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - Bevacizumab, AE-1390754, Protocol E1305, -FU2.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: June 22, 2009 SUBJECT: RTOG (0411), 0417,(0615), (0625), & 0825 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety report(s) from NCI for BEVACIZUMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by the NCI. The Following RTOG studies involve BEVACIZUMAB: RTOG (0411), "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417, "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG (0615), "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG (0625), "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" RTOG 0825, "Phase III Double-Blind Placebo-Controlled Trial of Conventional Concurrent Chemoradiation and Adjuvant Temozolomide Plus Bevacizumab Versus Conventional Concurrent Chemoradiation and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - Bevacizumab, AE-1987521, Protocol E5103, -FU1.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: June 19, 2009 SUBJECT: RTOG 0417, Closure Closure RTOG 0417, "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" will close to patient accrual at 5 PM EST, today, Friday, June 19th, as the study has met its primary accrual objective. Notice of this closure was previously broadcast on 6/4/09. Please notify your affiliates who are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Sites should not contact Michelle Buado for any other reason or reply directly to this broadcast. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. DATE: June 19, 2009 SUBJECT: RTOG eNews: Semiannual Meeting Book & Agenda Available on Web RTOG Semiannual Meeting Book & Agenda Available Online The RTOG Semiannual Meeting Book containing the study progress reports and the final meeting agenda are now available on the RTOG Web site. Please note that the meeting book is password protected. Copies of the Meeting Book will be available at the semiannual meeting in paper and CD formats. http://www.rtog.org/meeting/June_2009_Agenda.xls > https://silver1.phila.acr.org/Clinical_RTOG/RTOGSecureProtocolLogin.html> Contact Us If you need further information or wish to be added to or removed from our mailing list please send an e-mail to shartson@acr-arrs.org. RTOG's clinical trials are available at http://www.rtog.org/members/active.html. More information is available on the Web at www.rtog.org DATE: June 19, 2009 SUBJECT: RTOG 0841, On Hold ON HOLD RTOG 0841, "Efficiency Of Screening For Depression In Cancer Patients Receiving Radiotherapy" Patient accrual to RTOG 0841 is on hold for a revision to the protocol providing the details of the site's responsibility for preparing a referral list of mental health professionals in their local community and defining the details of the referral process. Please notify your affiliates that are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Sites should not contact Michelle Buado for any other reason or reply directly to this broadcast. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. DATE: June 19, 2009 SUBJECT: Repeat Credentialing for Advanced Technology Protocols Repeat Credentialing for Advanced Technology Protocols This message is to inform RTOG member institutions that it is necessary to repeat some credentialing procedures when technology changes are implemented. This is necessary when the technology changes are considered to be significant as defined by the Medical Physics Committee (MPC) and the Advanced Technology Integration Committee (ATIC). For IMRT credentialing that requires irradiation of a physical phantom supplied by the Radiological Physics Center (RPC), the following changes in technology require a repeat in the credentialing procedure: Changing from standard multileaf collimator IMRT dose delivery to Tomotherapy Changing from any IMRT technique to CyberKnife dose delivery (note that CyberKnife dose delivery is considered to be a related approach that requires IMRT credentialing for use in RTOG protocols) Changing from any of the traditional IMRT delivery techniques to volume arc delivery methods (e.g., RapidArc or VMAT) Changes in the method used for motion management for treatment in or near the thorax will also require repeating the credentialing process. This re-credentialing is necessary when the new motion management technique requires a different type of phantom irradiation. An example is a change from a technique that uses a stationary phantom irradiation for a lung Stereotactic Body Radiation Therapy (SBRT) treatment to an approach that requires a moving phantom. This would be the situation if an institution changes from the use of Automatic Breath Control (ABC) to a tracking technique. If you are uncertain about the need to repeat the credentialing process, please contact Ms. Tammy McGlade at RTOG Headquarters (phone 215-574-3219) and she will help you obtain answers to any questions relating to this matter. DATE: June 19, 2009 SUBJECT: RTOG 0539, Activated Activated RTOG 0539, "Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas" Institutions can download a copy of the protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/protocols/0539/0539.pdf Forms for this study also are available on the RTOG web site at http://www.rtog.org/members/forms/0539/main.html Special Study Notes: This study was selected by CTEP as a novel oncology trial for special support under the 2009 American Recovery and Reinvestment Act (ARRA) economic stimulus plan. Sites enrolling patients on RTOG 0539 will receive enhanced case payment, to be administered under CTEP's Accelerating Clinical Trials of Novel Oncologic PathWays (ACTNOW) program. CTEP designed the ACTNOW program to provide supplemental funds for select oncology trials that have the potential to complete accrual within 2 years. When RTOG and CTEP have finalized the terms of this funding, RTOG will send a broadcast to sites to describe the supplemental payment details. Regulatory Notes: NCI policy requires that the "Version Date" of the protocol title page reflect the date that the protocol was submitted by RTOG to NCI. The "Update Date" (the same as the activation date) indicates that administrative changes were made to the protocol after NCI approval; these changes are detailed in a summary of changes that can be accessed at http://www.rtog.org/members/protocols/0539/summary_changes.html Please notify your affiliates that are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Sites should not contact Michelle Buado for any other reason or reply directly to this broadcast. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. DATE: June 19, 2009 SUBJECT: Form Revision Notice - RTOG 0841 Form Revision Notice RTOG #0841 Efficiency of Screening for Depression in Cancer Patients Receiving Radiotherapy The following forms for this study have been revised. Download the new version from the RTOG web site at http://www.rtog.org/members/forms/0841/main.html The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date PQ PHQ-9 (PHQ-2) Form    PQa     6/15/09 HP HSCL-25 Form    HPa     6/15/09   Changes: Total score was added to the cover page on the PQ and the HP. Discard obsolete versions and commence use of the revised editions immediately. Please notify your joint center institutions and affiliates who are not on e-mail. Roseann Bonanni, CCRP RTOG Data Management DATE: June 18, 2009 SUBJECT: RTOG 0424, Updated: Summary of Changes Correction Attention RTOG 0424 Investigators: The summary of changes for the 6/18/09 update contained an error. The third-to-last update description should read: "Section 10.2.5 and Appendices VII and VIII: Contact information updated for the RTOG Biospecimen Resource" The summary of changes on the RTOG website will be updated in the near future to reflect the correction. ------------------------------------ From: RTOGBroadcast Sent: Thursday, June 18, 2009 11:00 AM To: RTOGBroadcast Cc: RTOGBroadcast Subject: RTOG 0424, Updated Updated RTOG 0424, "A Phase II Study of Temozolomide-Based Chemoradiotherapy Regimen for High Risk Low-Grade Gliomas" The timeframe in Section 2.6 was corrected from 36 months to 12 months; several sections were updated to current RTOG standard. Sites can access the complete summary of changes at http://www.rtog.org/members/protocols/0424/summary_changes.html Sites can download a copy of the updated protocol by accessing the RTOG web site at https://silver1.phila.acr.org/Clinical_RTOG/FileRendering.pdf The "Update Date" on the protocol title page indicates that editorial/administrative changes were made to the protocol. For clarity, the broadcast date of the update is provided in parentheses on each summary of change. IRB review of an update is not required; however, these changes must be reported to site IRBs. Please notify your affiliates that are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Sites should not contact Michelle Buado for any other reason or reply directly to this broadcast. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. DATE: June 18, 2009 SUBJECT: RTOG 0424, Updated Updated RTOG 0424, "A Phase II Study of Temozolomide-Based Chemoradiotherapy Regimen for High Risk Low-Grade Gliomas" The timeframe in Section 2.6 was corrected from 36 months to 12 months; several sections were updated to current RTOG standard. Sites can access the complete summary of changes at http://www.rtog.org/members/protocols/0424/summary_changes.html Sites can download a copy of the updated protocol by accessing the RTOG web site at https://silver1.phila.acr.org/Clinical_RTOG/FileRendering.pdf The "Update Date" on the protocol title page indicates that editorial/administrative changes were made to the protocol. For clarity, the broadcast date of the update is provided in parentheses on each summary of change. IRB review of an update is not required; however, these changes must be reported to site IRBs. Please notify your affiliates that are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Sites should not contact Michelle Buado for any other reason or reply directly to this broadcast. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. DATE: June 18, 2009 SUBJECT: RTOG Endorsed Study The following study has been endorsed by the Radiation Therapy Oncology Group and its Lung Committee: CALGB 30605, "A Phase II Study of Induction Chemotherapy Followed by Thoracic Radiotherapy and Erlotinib in Poor-Risk Stage III Non-Small Cell Lung Cancer" RTOG Co-Chair: Feng-Ming (Spring) Kong, MD, PhD, 734-936-7810, fengkong@umich.edu The protocol and forms are available on the CALGB web site and can be accessed via the RTOG web site at http://www.rtog.org/members/endorse.html (bottom of the page). Click on the study number to access the URL for the CALGB web site and the user name and password for RTOG sites on the RTOG title page. If the institution has difficulty accessing any of the documents on the CALGB web site, the institution should contact the CALGB Protocol Coordinator, Colleen RB Watt at 773-702-4670 or cboyle@uchicago.edu. Note: This study is not available on the CTSU menu. RTOG institutions must fax the completed "Registration Worksheet" (available in the CALGB forms packet) to RTOG Headquarters. After receiving the worksheet, the RTOG Registrar will contact the CALGB Registrar to register the patient. The RTOG Registrar will then e-mail the assigned case number to the RTOG institution. See Section 5.3 of the CALGB protocol for details. Please notify your affiliates who are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Sites should not contact Michelle Buado for any other reason or reply directly to this broadcast. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. DATE: June 17, 2009 SUBJECT: Form Revision Notice - RTOG 0537 Forms Revision Notice RTOG #0537 A Phase II/III Study Comparing Acupuncture-like Transcutaneous Electrical Nerve Stimulation (ALTENS) Versus Pilocarpine in Treating Early Radiation-Induced Xerostomia The following forms for this study have been revised. Download the new version from the RTOG web site at http://www.rtog.org/members/forms/0537/main.html The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date QF Treatment Summary Form    QFa     6/17/09 L4 Treatment Summary Form    L4a     6/17/09   Changes-QF-Q#6-added "specify" to the other question L4-internal changes. Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions will be returned to the site for transcription. Please notify your joint center institutions and affiliates who are not on e-mail. Roseann Bonanni, CCRP RTOG Data Management 215-574-3223 DATE: June 17, 2009 SUBJECT: RTOG 0513, Closure Notice Closure Notice RTOG 0513, "A Phase I/II Trial of Temozolomide, Motexafin Gadolinium, and 60 Gy Fractionated Radiation for Newly Diagnosed Supratentorial Glioblastoma Multiforme," will close to patient accrual at 5 PM EST Wednesday, July 1, because the study has met its accrual objective. Please notify your affiliates who are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Sites should not contact Michelle Buado for any other reason or reply directly to this broadcast. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. DATE: June 16, 2009 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0841 Web-based Electronic Data Submission is now available for the following form: RTOG # 0841 Efficiency of Screening for Depression in Cancer Patients Receiving Radiotherapy I1 Initial Evaluation Form Per previous Broadcasts, web-based data submission became mandatory as of May 14, 2007 for all forms available for web-entry for all cases enrolled through RTOG. A complete listing of forms available for web data submission is available at http://www.rtog.org/members/webreg.html For technical support with web data submission, please email websupport@acr-arrs.org. Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214. Please notify your joint center institutions and affiliates who are not on e-mail. Roseann Bonanni, CCRP RTOG Data Management DATE: June 15, 2009 SUBJECT: RTOG 0825 Kick-Off Reception Attached please find an invitation to the Wine & Cheese Kick-Off Reception for RTOG 0825 that will be held during the upcoming Semi-Annual Meeting. - RTOG 0825 Wine & Cheese Reception.doc DATE: June 12, 2009 SUBJECT: NSABP B-39/RTOG0413 BAHO substudy - Closure to Accrual Memo Investigators participating in NSABP B-39/RTOG 0413, "A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) for Women with Stage 0, I, or II Breast Cancer": RTOG received the attached memo from NSABP (dated 5/28/09), notifying all sites participating in the B-39/0413 trial that the accrual goal for the BAHO substudy (which includes the Quality of Life questionnaires, MD-reported cosmesis assessment, and digital photos assessments) has been met. Please do not offer any further patients the opportunity to participate in the BAHO substudy. NOTE: This study is still open to patient accrual. Please read the memo carefully for details regarding the closure to accrual of the BAHO substudy. - B-39 BAHO Closure to Accrual_05-27-2009.pdf Please notify your joint center institutions and affiliates who are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Sites should not contact Michelle Buado for any other reason or reply directly to this broadcast. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. DATE: June 11, 2009 SUBJECT: RTOG (0411), 0417,(0615), (0625), & 0825 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety report(s) from NCI for BEVACIZUMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by the NCI. The Following RTOG studies involve BEVACIZUMAB: RTOG (0411), "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417, "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG (0615), "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG (0625), "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" RTOG 0825, "Phase III Double-Blind Placebo-Controlled Trial of Conventional Concurrent Chemoradiation and Adjuvant Temozolomide Plus Bevacizumab Versus Conventional Concurrent Chemoradiation and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - Bevacizumab CCI-779, AE-1257729, Protocol E2804, -ISR.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: June 11, 2009 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0214 Web-Based Electronic Data Submission is now available for the following RTOG LUNG study form: RTOG # 0214 PROPHYLACTIC CRANIAL IRRADIATION FOR NON SMALL CELL LUNG CANCER F1 Follow-up Form Per previous Broadcasts, web-based data submission became mandatory as of May 14, 2007 for all forms available for web-entry for all cases enrolled through RTOG. A complete listing of forms available for web data submission is available at http://www.rtog.org/members/webreg.html For technical support with web data submission, please email websupport@acr-arrs.org Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214. Forms received in paper format after June 30, 2009 will be returned to the site for transcription. Please notify your joint center institutions and affiliates who are not on e-mail. Mary Gramkowski, RN, BA, CCRP RTOG Data Management DATE: June 11, 2009 SUBJECT: RTOG 0234, Updated Updated RTOG 0234, "A Phase II Randomized Trial of Surgery Followed by Chemoradiotherapy Plus C225 (Cetuximab) for Advanced Squamous Cell Carcinoma of the Head and Neck", (a closed study): Section 10.0 and Appendix VI were updated with the RTOG Biospecimen Resource shipping address and contact information. Sites can access the complete summary of changes at http://www.rtog.org/members/protocols/0234/summary_changes.html. Sites can download a copy of the updated protocol by accessing the RTOG web site at http://www.rtog.org/members/protocols/0234/0234.pdf . The "Update Date" on the protocol title page indicates that editorial/administrative changes were made to the protocol. For clarity, the broadcast date of the update is provided in parentheses on each summary of change. IRB review of an update is not required; however, these changes must be reported to site IRBs. Please notify your affiliates that are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, please e-mail mbuado@acr-arrs.org. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. DATE: June 9, 2009 SUBJECT: RTOG (0411), 0417,(0615), (0625), & 0825 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety report(s) from NCI for BEVACIZUMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by the NCI. The Following RTOG studies involve BEVACIZUMAB: RTOG (0411), "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417, "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG (0615) , "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG (0625) , "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" RTOG 0825, "Phase III Double-Blind Placebo-Controlled Trial of Conventional Concurrent Chemoradiation and Adjuvant Temozolomide Plus Bevacizumab Versus Conventional Concurrent Chemoradiation and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - Bevacizumb, AE-1881593, Protocol CALGB-40503, -FU1.pdf - Bevacizumab CCI-779, AE-1718620, Protocol GOG-0229G, -FU1.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: June 9, 2009 SUBJECT: RTOG 99-09, Terminated Terminated RTOG 99-09, "Phase II Study of Postoperative Adjuvant Immunotherapy and Radiation in Patients with Completely Resected Stage II and Stage IIIA Non-Small Cell Lung Cancer", has been terminated, effective today, June 9, 2009. As of today, all study activity and data collection will cease, and any data received at RTOG Headquarters after today will be returned to the submitting institution. Institutions should notify their local IRBs/REBs of this termination. Please notify your affiliates that are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, please e-mail mbuado@acr-arrs.org. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. DATE: June 8, 2009 SUBJECT: RTOG (0411), 0417,(0615), (0625), & 0825 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety report(s) from NCI for BEVACIZUMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by the NCI. The Following RTOG studies involve BEVACIZUMAB: RTOG (0411), "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417, "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG (0615), "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG (0625), "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" RTOG 0825, "Phase III Double-Blind Placebo-Controlled Trial of Conventional Concurrent Chemoradiation and Adjuvant Temozolomide Plus Bevacizumab Versus Conventional Concurrent Chemoradiation and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - Bevacizumab, AE-1968432, Protocol GOG-0218, -FU1.pdf - Bevacizumab, AE-1202538, Protocol GOG-0218, -ISR.PDF - Bevacizumab, AE-1158823, Protocol E5103, -FU1.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: June 8, 2009 SUBJECT: RTOG 0320 PROTOCOL NOTICE: NCI SAFETY REPORT for ERLOTINIB RTOG has received safety report(s) from the NCI/NIH for Erlotinib the Following RTOG study(s) involve Erlotinib: Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by the NCI. RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR ERLOTINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - CCI-779 OSI-774, AE-1192065, Protocol NABTC-04-02, -FU1.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: June 5, 2009 SUBJECT: RTOG 0524, Accrual Suspension Accrual Suspension RTOG 0524, "A Phase I/II Trial Of A Combination Of Paclitaxel And Trastuzumab With Daily Irradiation Or Paclitaxel Alone With Daily Irradiation Following Transurethral Surgery For Non-Cystectomy Candidates With Muscle-Invasive Bladder Cancer" Effective immediately, accrual of new patients to RTOG 0524 is temporarily suspended until the protocol consent is amended for the addition of risk for "bowel perforation". Patients currently on study may continue study treatment. Note: RTOG has expired all prior site IRB approvals for the study. Please notify your affiliates that are not on e-mail. Please notify your affiliates who are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Sites should not contact Michelle Buado for any other reason or reply directly to this broadcast. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. DATE: June 5, 2009 SUBJECT: Form Revision Notice - RTOG 0619 RTOG # 0619 A RANDOMIZED PHASE II TRIAL OF CHEMORADIOTHERAPY VERSUS CHEMORADIOTHERAPY AND VANDETANIB FOR HIGH-RISK POSTOPERATIVE ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK Form Revision Notice The following form for this study has been revised. Download the new version from the RTOG web site at http://www.rtog.org/pdf_forms.html?members/forms=0619/0619%20TF.pdf The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date TF Treatment Summary Form    TFa     6-5-09   Changes Made: Question 1a added - Patient Height (cm) This form is currently available for web data submission Web-based data submission is mandatory for all forms that are available for web-entry for all cases enrolled through RTOG. A complete listing of all forms available for web-entry is available at http://www.rtog.org/members/webreg.html For technical support with web data submission, please email websupport@acr-arrs.org. Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214. Please commence use of this revised edition immediately. Please notify your joint center institutions and affiliates who are not on e-mail. Joli Lavarino, B.A.. C.C.R.P. RTOG Data Management DATE: June 4, 2009 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0712 RTOG 0712 A Phase II Randomized Study For Patients With Muscle-Invasive Bladder Cancer Evaluating Transurethral Surgery And Concomitant Chemoradiation By Either BID Irradiation Plus 5-Fluorouracil And Cisplatin Or QD Irradiation Plus Gemcitabine Followed By Selective Bladder Preservation And Gemcitabine/Cisplatin Adjuvant Chemotherapy Web-Based Electronic Data Submission is now available for the following form: RTOG 0712 SF form (Treatment Summary Form-Consolidation) Per previous Broadcasts, web-based data submission became mandatory as of May 14, 2007 for all forms available for web-entry for all cases enrolled through RTOG. A complete listing of forms available for web data submission is available at http://www.rtog.org/members/webreg.html For technical support with web data submission, please email websupport@acr-arrs.org Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214. Elaine Motyka-Welsh, RN, MSN, CCRP Research Associate DATE: June 4, 2009 SUBJECT: RTOG 0320 PROTOCOL NOTICE: NCI SAFETY REPORT for ERLOTINIB RTOG has received safety report(s) from the NCI/NIH for Erlotinib the Following RTOG study(s) involve Erlotinib: Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by the NCI. RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR ERLOTINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - OSI-774, Investigator Notification, OSI Pharmaceuticals Report 2009000831, May 22, 2009.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: June 4, 2009 SUBJECT: RTOG 0417, Closure Notice Closure Notice RTOG 0417, "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" will close to patient accrual at 5 PM EST Friday, June 19, because the study has met its primary accrual objective. Please notify your affiliates who are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Sites should not contact Michelle Buado for any other reason or reply directly to this broadcast. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. DATE: June 3, 2009 SUBJECT: Form Revision Notice - RTOG 0534 RTOG # 0534 Phase III trial of short term androgen deprivation with pelvic lymph node or prostate bed only radiotherapy (SPPORT)in prostate cancer patients with a rising PSA after radical prostatectomy Form Revision Notice The following forms for this study have been revised. Download the new versions from the RTOG web site at http://www.rtog.org/members/forms/0534/main.html The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date I1 Initial Evaluation Form    I1a     06/03/09 F0 Interim Follow-up Form    F0b     06/03/09 F1 Follow-up Form    F1b     06/03/09   Changes Made: Q#23 on the I1-include the WBC value Q#10 on the F0 and F1 data collection lab values per the protocol The forms listed above are currently available for web data submission Web-based data submission is mandatory for all forms that are available for web-entry for all cases enrolled through RTOG. A complete listing of all forms available for web-entry is available at http://www.rtog.org/members/webreg.html For technical support with web data submission, please email websupport@acr-arrs.org. Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214. Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions received after June 12, 2009 will be returned to the site for transcription. Please notify your joint center institutions and affiliates who are not on e-mail. Roseann Bonanni, CCRP RTOG Data Management DATE: June 3, 2009 SUBJECT: RTOG (0411), 0417,(0615), (0625), & 0825 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety report(s) from NCI for BEVACIZUMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by the NCI. The Following RTOG studies involve BEVACIZUMAB: RTOG (0411), "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417, "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG (0615), "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG (0625), "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" RTOG 0825, "Phase III Double-Blind Placebo-Controlled Trial of Conventional Concurrent Chemoradiation and Adjuvant Temozolomide Plus Bevacizumab Versus Conventional Concurrent Chemoradiation and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - Bevacizumab CCI-779, AE-1718620, Protocol E1505, -ISR.PDF - Bevacizumab CCI-779, AE-1392926, Protocol GOG-0229, -ISR.PDF - Bevacizumab CCI-779, AE-1360351, Protocol 7190, -FU1.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: June 3, 2009 SUBJECT: RTOG 0320 PROTOCOL NOTICE: NCI SAFETY REPORT for ERLOTINIB RTOG has received safety report(s) from the NCI/NIH for Erlotinib the Following RTOG study(s) involve Erlotinib: Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by the NCI. RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR ERLOTINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - OSI-774, AE-1225018, Protocol CALGB-30406, FU1.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: June 3, 2009 SUBJECT: Form Revision Notice - RTOG 0436 Web-based Electronic Data Submission Radiation Therapy Oncology Group RTOG 0436 "A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients with Esophageal Cancer Who Are Treated Without Surgery" Per previous Broadcasts, web-based data submission became mandatory as of May 14, 2007 for all forms available for web-entry for all cases enrolled through RTOG. A complete listing of forms available for web data submission is available at http://www.rtog.org/members/webreg.html For technical support with web data submission, please email websupport@acr-arrs.org. Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214. Forms Revision Notice The following form for this study has been revised. Download the new version from the RTOG web site at http://www.rtog.org/pdf_forms.html?members/forms=0436/0436%20I1.pdf The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date I1 Initial Evaluation Form    I1b     06/02/2009   Changes: Question 7(QNO27) - Response list updated Discard obsolete versions and commence use of the revised edition immediately. Obsolete versions received after June 19th 2009 will be returned to the site for transcription. Please notify your joint center institutions and affiliates who are not on e-mail. Debora Grant, RN, MSN RTOG Research Associate DATE: June 2, 2009 SUBJECT: RTOG (0411), 0417,(0615), (0625), & 0825 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety report(s) from NCI for BEVACIZUMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by the NCI. The Following RTOG studies involve BEVACIZUMAB: RTOG (0411), "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417, "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG (0615), "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG (0625), "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" RTOG 0825, "Phase III Double-Blind Placebo-Controlled Trial of Conventional Concurrent Chemoradiation and Adjuvant Temozolomide Plus Bevacizumab Versus Conventional Concurrent Chemoradiation and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - Bevacizumab,AE-1950915, Protocol E5103, -ISR.PDF Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: June 2, 2009 SUBJECT: RTOG 98-11 and 0529, Updated Updated RTOG 98-11, "A Phase III Randomized Study of 5-Fluorouracil, Mitomycin-C, and Radiotherapy versus 5-Fluorouracil, Cisplatin and Radiotherapy in Carcinoma of the Anal Canal" and RTOG 0529, "A Phase II Evaluation of Dose-Painted IMRT in Combination with 5-Fluorouracil and Mitomycin-C for Reduction of Acute Morbidity in Carcinoma of the Anal Canal" The contact and shipping information for the submission of specimens in each of these studies has been updated to the RTOG Biospecimen Resource at the University of California San Francisco. Sites can access the complete summary of changes for each study at http://www.rtog.org/members/protocols/98-11/summary_changes.html and http://www.rtog.org/members/protocols/0529/summary_changes.html Sites can download a copy of each protocol for IRB review at http://www.rtog.org/members/protocols/98-11/9811.pdf and http://www.rtog.org/members/protocols/0529/0529.pdf The "Update Date" on the protocol title page indicates that editorial/administrative changes were made to the protocol. For clarity, the broadcast date of the update is provided in parentheses on each summary of change. IRB review of an update is not required; however, these changes must be reported to site IRBs. Please notify your affiliates that are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Sites should not contact Michelle Buado for any other reason or reply directly to this broadcast. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. DATE: June 2, 2009 SUBJECT: Follow-Up: RTOG 0627, Notification of Action Letter and Amendment Forthcoming (Re-Opened & Amended) RTOG 0627, "Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme," has been re-opened to accrual and amended as follows: Action Letter (Amendment 4): RTOG has received an Action Letter from NCI/NIH for dasatinib (BMS-354825, NSC 732517, IND 73969). Accrual of new patients WILL REMAIN SUSPENDED until the IRB of record has reviewed and approved the CTEP-approved amendment for this study that addresses the information in the Action Letter. The Action Letter is attached and must accompany the amendment. Amendment 5: Based on a protocol-specified efficacy analysis, the protocol was amended to allow intrapatient dose escalation. Pharmacokinetic analyses were also incorporated. Amendment 6: Clarifications were made to the AE reporting and statistical sections. Sites can access complete Summary of Changes for Amendment 4, Amendment 5, and Amendment 6 at http://www.rtog.org/members/protocols/0627/summary_changes.html Sites can download a copy of the amended protocol for IRB review at http://www.rtog.org/members/protocols/0627/0627.pdf NCI policy requires that the "Version Date" on the protocol title page reflect the date that the most recent amendment was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses. Please submit the amendments and Action Letter to your institutional IRB. A copy should be retained in your protocol file. CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. Because these amendments involve changes to the risks section of the consent, RTOG recommends re-consenting patients on this trial; however, your local IRB will have the final authority. Note: RTOG has expired all prior site IRB approvals for the study. U.S. sites and Canadian sites must fax a copy of the IRB/REB approval letter to the CTSU Regulatory Office (215-569-0206) prior to registering patients. Please notify your affiliates that are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Sites should not contact Michelle Buado for any other reason or reply directly to this broadcast. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at http://www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. - ACTION LETTER_Dasatinib (BMS-354825)_NSC 732517_IND 73969_February 10, 2009.pdf _____________________________________ From: RTOGBroadcast Sent: Tuesday, February 24, 2009 2:54 PM To: RTOGBroadcast Cc: RTOGBroadcast Subject: RTOG 0627, Notification of Action Letter and Amendment Forthcoming Importance: High RTOG has received an ACTION LETTER from NCI/NIH for dasatinib (BMS-354825, NSC 732517, IND 73969). The Action Letter pertains to RTOG 0627, "Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme" (temporarily closed to accrual). Patients currently on study may continue on study provided they are informed of the new and/or modified risk information. This information should be communicated to patients already enrolled on study without waiting for IRB review/approval since this information represents a significant new finding(s) that developed during the course of the research that may relate to a patient's willingness to continue participation and per the Office for Human Research Protections, the regulations do not require IRB review and approval of statements describing such significant new findings before they are provided to already enrolled patients. Documentation of their informed consent should be carried out according to local IRB requirements. Please see the attached risk modifications, extracted from the action letter. RTOG will broadcast the action letter and amended protocol in the near future. Please be advised, in addition to the action letter amendment, RTOG will incorporate additional modifications to the protocol, at which time the study is expected to re-open to patient accrual. Please notify your affiliates that are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Sites should not contact Michelle Buado for any other reason or reply directly to this broadcast. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: June 2, 2009 SUBJECT: RTOG (0411), 0417,(0615), (0625), & 0825 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety report(s) from NCI for BEVACIZUMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by the NCI. The Following RTOG studies involve BEVACIZUMAB: RTOG (0411), "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417, "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG (0615), "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG (0625), "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" RTOG 0825, "Phase III Double-Blind Placebo-Controlled Trial of Conventional Concurrent Chemoradiation and Adjuvant Temozolomide Plus Bevacizumab Versus Conventional Concurrent Chemoradiation and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - Bevacizumab,AE-1192440, Protocol CALGB-40502, -ISR.PDF - Bevacizumab,AE-1232396, Protocol E5202, -ISR.PDF - Bevacizumab,AE-1390754, Protocol E1305, -ISR.PDF - Bevacizumab,AE-1333814, Protocol E5103, -ISR.PDF Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 29, 2009 SUBJECT: RTOG 0841 - Quality of Life Forms The following study has been endorsed by the Radiation Therapy Oncology Group and its Breast Working Group Committee: NSABP B-43, "A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy" RTOG Co-Chair: Rachel Rabinovitch, MD, University of Colorado Comprehensive Cancer Center, 720-848-0156, Rachel.Rabinovitch@UCHSC.edu Enrollment procedures and data collection for this study must be done via the Clinical Trials Support Unit (CTSU). The enrolling investigator must be a CTSU member investigator. Investigator registration, credentialing information, and the protocol can be accessed at http://www.ctsu.org RTOG institutions that enter patients on any CTSU trial can receive credit toward RTOG membership accrual requirements. The enrolling investigator must declare RTOG membership at the time of registration in order to receive RTOG credit. Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 29, 2009 SUBJECT: RTOG 0841 - Quality of Life Forms RTOG 0841 Efficiency of Screening for Depression in Cancer Patients Receiving Radiotherapy Quality of Life Forms When submitting the Quality of Life Forms, the HP, PQ and QL forms, please use the forms on the web and not the appendices in the back of the protocol. It is necessary for the cover pages on these forms be completed. Please notify your joint center institutions and affiliates who are not on e-mail. Roseann Bonanni, CCRP RTOG Data Management DATE: May 28, 2009 SUBJECT: Request for Data for Upcoming Analysis on RTOG 0129 ALL INSTITUTIONS PARTICIPATING IN RTOG 0129 A late breaking abstract submission will be submitted to the 2009 ASTRO meeting for RTOG 0129, reporting the results from the treatment comparison (standard once a day vs. altered fractionated radiation therapy). It is critical to have as current as possible follow-up data on every case for the analysis. Please review your OPS tool and submit all outstanding data due through June 5th, 2009 to RTOG Headquarters by June 19th, 2009. You can access the OPS tool via the following link: https://silver1.phila.acr.org/Clinical_RTOG/pgSiteTools.html or go to the RTOG home page and click on SITE TOOLS which is located next to the DATA CENTER LOGIN. Please notify your joint center institutions and affiliates who are not on e-mail. Please direct any questions about outstanding data to the Research Associate listed below. Thank you for your cooperation. Joli Lavarino, BA, CCRP RTOG Data Management 215-574-3154 215-940-8830 (fax) DATE: May 28, 2009 SUBJECT: RTOG 0320, Action Letter and Amendment - ACTION LETTER_Erlotinib (OSI-774, TarcevaR)__NSC 718781_IND 63383_May 27, 2009.pdf Action Letter and Amendment 7 RTOG 0320, "Phase III Trial Comparing Whole Brain Radiation and Stereotactic Radiosurgery Alone Versus With Temozolomide or Erlotinib in Patients With Non-Small Lung Cancer and 1-3 Brain Metastases" RTOG has received an ACTION LETTER from NCI/NIH for erlotinib (OSI-774, Tarceva®) IND 63383. Accrual of new patients to RTOG 0320 is SUSPENDED until the IRB of record has reviewed and approved the CTEP-approved amendment for this study that addresses the information in the Action Letter. Sites can access the amended protocol at: http://www.rtog.org/members/protocols/0320/0320.pdf Sites can access the complete Summary of Changes for the amendment at http://www.rtog.org/members/protocols/0320/summary_changes.html Patients currently on study may continue on study provided they are informed of the new risks identified as part of the CAEPR update in the Action Letter. The Action Letter is attached and must accompany the amendment. NCI policy requires that the "Version Date" on the protocol title page reflect the date that the most recent amendment was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses. Please submit the amendments and Action Letter to your institutional IRB. A copy should be retained in your protocol file. Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. This amendment involves changes to the risks section of the consent. RTOG recommends re-consenting patients on this trial; however, your local IRB will have the final authority. Note: RTOG has expired all prior site IRB approvals for the study. U.S. sites and Canadian sites must fax a copy of the IRB/REB approval letter to the CTSU Regulatory Office (215-569-0206) prior to registering patients. Please notify your affiliates that are not on e-mail. DATE: May 28, 2009 SUBJECT: Submission of F1 Forms for RTOG 9003, 9903, 9914, 0022, 0024, 0129 & 0225 SUBMISSION OF F1 FORMS FOR RTOG 9003, 9903, 9914, 0022, 0024, 0129 and 0225 Please note that the FF (long-term follow-up) form is no longer being collected on the studies listed above. These FF forms have been removed from the case calendars and replaced with the F1 (follow-up) form. Effectively immediately RTOG will no longer accept FF forms on the above noted studies. These will be returned to the site for transcription. Thank you for your cooperation. Please notify your joint center institutions and affiliates who are not on e-mail. Joli Lavarino, BA, CCRP Research Associate- Head and Neck Team 215-574-3154 Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 28, 2009 SUBJECT: RTOG 0524 PROTOCOL NOTICE: NCI SAFETY REPORTS FOR TRASTUZUMAB RTOG has received safety report(s) from NCI for TRASTUZUMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by NCI. The Following RTOG studies involve TRASTUZUMAB: RTOG 0524, "A PHASE I/II TRIAL OF A COMBINATION OF PACLITAXEL AND TRASTUZUMAB WITH DAILY IRRADIATION OR PACLITAXEL ALONE WITH DAILY IRRADIATION FOLLOWING TRANSURETHRAL SURGERY FOR NON-CYSTECTOMY CANDIDATES WITH MUSCLE-INVASIVE BLADDER CANCER" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - Trastuzumab,AE-1353951, Protocol RTOG-0524, -ISR.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 28, 2009 SUBJECT: RTOG 0841, Activated Activated RTOG 0841, "Efficiency Of Screening For Depression In Cancer Patients Receiving Radiotherapy" Institutions can download a copy of the protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/protocols/0841/0841.pdf Forms for this study also are available on the RTOG web site at http://www.rtog.org/members/forms/0841/main.html Regulatory Notes: NCI policy requires that the "Version Date" of the protocol title page reflect the date that the protocol was submitted by RTOG to NCI. The "Update Date" (the same as the activation date) indicates that administrative changes were made to the protocol after NCI approval; these changes are detailed in a summary of changes that can be accessed at http://www.rtog.org/members/protocols/0841/summary_changes.html Please notify your affiliates that are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Sites should not contact Michelle Buado for any other reason or reply directly to this broadcast. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. DATE: May 28, 2009 SUBJECT: RTOG 0436, Updated Updated RTOG 0436, "A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients with Esophageal Cancer Who Are Treated Without Surgery" was updated to correct a typo in the first sentence of Section 7.9. Sites can access the complete summary of changes at http://www.rtog.org/members/protocols/0436/summary_changes.html Sites can download a copy of the updated protocol by accessing the RTOG web site at http://www.rtog.org/members/protocols/0436/0436.pdf NOTE: The Summary of Changes for Amendment #1, which was broadcast 3/31/09, has been corrected. The hours of the CTSU were corrected from 9:00-4:30 to 9:00-5:30. This change was made to the Summary of Changes ONLY as the protocol was correct. NCI policy requires that the "Version Date" on the protocol title page reflect the date the protocol was submitted by RTOG to NCI; the "Update Date" indicates that editorial/administrative changes were made to the protocol. IRB review of an update is not required; however, these changes must be reported to site IRBs. Please notify your affiliates that are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Sites should not contact Michelle Buado for any other reason or reply directly to this broadcast. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. DATE: May 27, 2009 SUBJECT: RTOG eNews: RTOG Semiannual Symposium & Keynote Address RTOG eNews May 27, 2009 Q. Ed Zhang, PhD, Named New RTOG Senior Statistician Q. Ed Zhang, Ph.D., has joined RTOG as a senior statistician in the group's Statistics and Data Management Center. Dr. Zhang's is the new leader for center's head and neck cancer and sarcoma research team. Dr. Zhang holds a Ph.D. in biostatistics and a MPH in international and family health from the University of Texas at Houston School of Public Health as well as a MS in pathology and a BM in medicine from the China Medical University in the Peoples Republic of China. Prior to coming to RTOG Dr. Zhang was a faculty biostatistician in the Department of Pediatrics at George Washington University School of Medicine and a principal biostatistician at GlaxoSmithKline in King of Prussia, PA. Dr. Zhang assumed the responsibility for the head and neck cancer and sarcoma research team from Thomas F. Pajak, Ph.D., who will continue to work on special projects for RTOG on a part-time basis. "I look forward to working with everyone in the team to best support our clinical research activities." said Dr. Zhang. "There are many exciting ongoing projects in development within the group that will make this position very interesting." "Dr. Zhang is a welcome addition to our statistical staff," said Walter J. Curran, Jr., M.D., the RTOG Group Chair. "His background and research interests fit in very well with the needs of our group and I know he will be an asset to the RTOG." RTOG ASCO Abstracts Available A booklet with the 8 http://www.rtog.org/pdf_file.html?abstracts=RTOG%20ASCO%202009%20Presentations.pdf being presented at ASCO this weekend is available on the RTOG Web site. http://www.rtog.org/pdf_file.html?abstracts=RTOG%20ASCO%202009%20Presentations.pdf Contact Us If you need further information or wish to be added to or removed from our mailing list please send an e-mail to Sharon Hartson Stine at: shartson@acr-arrs.org. RTOG's clinical trials are available at http://www.rtog.org/members/active.html. More information is available on the Web at www.rtog.org. DATE: May 27, 2009 SUBJECT: Upcoming Important Statistical Analysis for RTOG 9601 ALL INSTITUTIONS PARTICIPATING IN RTOG 9601 An upcoming important statistical analysis will be done for RTOG 9601. Please review your OPS tool and submit all outstanding data due through June 30th, 2009 to RTOG Headquarters by July 15th, 2009. You can access the OPS tool via the following link: https://silver1.phila.acr.org/Clinical_RTOG/pgSiteTools.html or go to the RTOG home page and click on SITE TOOLS which is located next to the DATA CENTER LOGIN. Please notify your joint center institutions and affiliates who are not on e-mail. Please direct any questions about outstanding data to the Research Associate listed below. Thank you for your cooperation. Elaine Motyka Welsh, RN, MSN, CCRP RTOG Data Management 215-574-3216 DATE: May 27, 2009 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0024 WEB-BASED ELECTRONIC DATA SUBMISSION IS NOW AVAILABLE FOR RTOG # 0024 F1 Follow-Up Form Per previous Broadcasts, web-based data submission became mandatory as of May 14, 2007 for all forms available for web-entry for all cases. A complete listing of forms available for web data submission is available at http://www.rtog.org/members/webreg.html For technical support with web data submission, please email websupport@acr-arrs.org. Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214. Forms received in paper format after June 22, 2009 will be returned to the site for transcription. Please notify your joint center institutions and affiliates who are not on e-mail. Joli Lavarino, B.A., C.C.R.P. RTOG Data Management DATE: May 26, 2009 SUBJECT: RTOG eNews: RTOG ASCO Presentations RTOG eNews May 26, 2009 RTOG Semiannual Meeting Symposium: Globalization of RTOG Research Programs Friday, June 26, 2009, 9:00 - Noon Introduction Walter J. Curran, Jr., MD, RTOG Group Chair, Emory University NCI Perspective Ted Trimble, MD, MPH, National Cancer Institute Pharmacogenetics of Cancer Suresh S. Ramalingam, MD, Emory University Corey J. Langer, MD, University of Pennsylvania Pharmaceutical Perspective - Lessons Learned Fouad Namouni, MD, Executive Director, Oncology, Bristol-Myers Squibb RTOG Perspective - Full Member PI Perspective, Challenges in Mentoring Elizabeth Gore, MD, Medical College of Wisconsin - International Member - Becoming an RTOG Member Benjamin W. Corn, MD, Tel Aviv Sourasky Medical Center - Canadian Experience Michael Goodyear, BMedSC MBBS, Dalhousie University - RTOG/EORTC Collaboration Wilma Hoffman, RN, BSN, RTOG Senior Director - RTQA & Technology Assessment James M. Galvin, DSc, Thomas Jefferson University James A. Deye, PhD, National Cancer Institute Quality of Life-Multicultural Perspective Benjamin Movsas, MD, Henry Ford Health System Panel Discussion & Summary Mohan Suntharalingham, MD, RTOG Vice Chair Membership, University of Maryland Plenary Session - Keynote Address Saturday, June 27, 2009 Global Trends in Oncology Otis W. Brawley, MD, Chief Medical Officer, American Cancer Society Semiannual Meeting Registration It is still not too late to register for the RTOG Semiannual Meeting that will be held June 25-28, 2009 at the Chicago Marriott Downtown. Complete meeting agendas and registration materials are available on the RTOG Web site. Make your reservations now! meeting materials Contact Us If you need further information or wish to be added to or removed from our mailing list please send an e-mail to Sharon Hartson Stine at: shartson@acr-arrs.org. RTOG's clinical trials are available at http://www.rtog.org/members/active.html. More information is available on the Web at www.rtog.org. DATE: May 22, 2009 SUBJECT: RTOG eNews: RTOG ASCO Presentations RTOG eNews May 22, 2009 RTOG ASCO Presentations RTOG investigators will present eight abstracts at the American Society of Clinical Oncology (ASCO) annual meeting in Orlando, Fl May 29 through June 2, 2009. If you are attending ASCO please make sure to visit the RTOG booth (#219). Below is a list of the presentations. Bone Metastases RTOG 9714 Randomized Trial of Short- Versus Long-Course Radiotherapy for Palliation of Painful Vertebral Bone Metastases: A Retrospective Analysis of RTOG 97-14. Howell DD, James JL, Hartsell WF, Suntharalingam M, Machtay M, Suh JH, Demas WF, Sandler HM, Kachnic LA, Berk LB. (poster discussion #9521, Sunday, May 31, Sunday, May 31, 5:00 PM - 6:00 PM , Session 5, Level 3, W304E. Poster viewing: 2:00 PM - 6:00 PM, Level 3, W340A) Brain Tumors RTOG 0625 RTOG 0625: A Phase II Study of Bevacizumab with Irinotecan in Recurrent Glioblastoma (GBM) . Gilbert M, Wang M, Aldape K, Sorensen A, Walker E, Regine W, Glass J, Lassman A, Mehta M. (poster discussion #2011, Saturday, May 30, 12:00 PM - 1:00 PM Level 3, W330A. Poster viewing: 8:00 AM - 12:00 PM Level 3, W340A) RTOG 0525 MGMT Methylation Testing in RTOG 0525, a Phase III Trial of Newly Diagnosed Glioblastoma. Aldape K, Jones G, Wang M, Hegi M, Janzer R, Stupp R, Mehta M, Gilbert M. (poster presentation #2051, Sunday, May 31, 8:00 AM - 12:00 PM, Level 2, West Hall C) Head & Neck Cancer RTOG 0129 Survival Outcomes by Tumor Human Papillomavirus (HPV) Status in Stage III-IV Oropharyngeal Cancer (OPC) in RTOG 0129. Gillison M, Harris J, Westra W, Chung CH, Jordan R, Rosenthal DI, Nguyen-Tan PF, Spanos WJ, Redmond KP, Ang KK. (oral presentation #6003 Saturday, May 30, 3:00 PM - 6:00 PM, Level 4, Valencia Room, W415D) Lung Cancer RTOG 0214 A Phase III Comparison of Prophylactic Cranial Irradiation Versus Observation in Patients with Locally Advanced Non-Small Cell Lung Cancer: Initial Analysis of Radiation Therapy Oncology Group 0214. Gore E, Bae K, Wong S, Bonner J, Sun A, Schild S, Gaspar L, Bogart J, Werner-Wasik M, Choy H. (oral presentation #7506, Monday, June 1, 3:00 PM - 6:00 PM, Session 20, Level 3, Chapin Theater W320) RTOG 0239 A Phase II Study of Accelerated High Dose Thoracic Radiation Therapy (AHTRT) with Concurrent Chemotherapy for Limited Small Cell Lung Cancer: RTOG 0239. Komaki R, Paulus R, Ettinger D, Videtic GM, Bradley JD, Glisson BS, Choy H. (poster discussion #7527, Saturday, May 30, Saturday, May 30, 12:00 PM - 1:00 PM, Level 3, Chapin Theater W320. Poster viewing:?8:00 AM - 12:00 PM, Level 3, W315A) Prostate Cancer Impact of Ultra-High Baseline PSA Level on Biochemical and Clinical Outcomes in a Set of RTOG Prostate Cancer Trials. Rodrigues G, Bae K, Roach M, Lawton C, Donnelly B, Grignon D, Hanks GE, Porter A, Lepor H, Sandler H. (poster presentation #5123, Sunday, May 31, 2:00 PM - 6:00 PM , Session H4 , Level 2, West Hall C) Sarcoma RTOG 0132 Gastrointestinal Stromal Tumor (GIST) Gene Expression Signatures Correlated to Rapid Response to Imatinib Mesylate (IM) in a Phase II Clinical Trial. Rink L, Skorobogatko Y, Kossenkov A, Belinsky M, Pajak T, von Mehren M, Ochs M, Eisenberg, B, Godwin A. (poster discussion #10533, Saturday, May 30, 5:00 PM - 6:00 PM, Level 2, West Hall F5. Poster viewing: 2:00 PM - 6:00 PM, Level 2, W240A) Contact Us If you need further information or wish to be added to or removed from our mailing list please send an e-mail to Sharon Hartson Stine at: shartson@acr-arrs.org. RTOG's clinical trials are available at http://www.rtog.org/members/active.html. More information is available on the Web at www.rtog.org. DATE: May 22, 2009 SUBJECT: RTOG (0324), (0234), (0522), 0436, & 0617 PROTOCOL NOTICE: BMS, ImClone and/or NCI SAFETY REPORTS FOR CETUXIMAB RTOG has received safety report(s) from BMS, ImClone, and/or NCI for CETUXIMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by BMS, ImClone, and/or NCI. The Following RTOG studies involve CETUXIMAB: RTOG (0324) "A PHASE II STUDY OF CETUXIMAB (C225) IN COMBINATION WITH CHEMORADIATION IN PATIENTS WITH STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC)" RTOG (0234) "A PHASE II RANDOMIZED TRIAL OF SURGERY FOLLOWED BY CHEMORADIOTHERAPY PLUS C225 (CETUXIMAB) FOR ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK" RTOG (0522) "A PHASE III TRIAL OF CONCURRENT ACCELERATED RADIATION AND CISPLATIN VERSUS CONCURRENT ACCELERATED RADIATION, CISPLATIN, AND CETUXIMAB (C225) FOLLOWED BY SURGERY FOR RESIDUAL DISEASE FOR STAGE III AND IV HEAD AND NECK CARCINOMAS" RTOG 0436, "A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery" RTOG 0617/NCCTG N0628/CALGB 30609/ECOG R0617, "A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy with Concurrent and Consolidation Carboplatin/Paclitaxel +/-Cetuximab (IND#103444) in Patients with Stage IIIA/IIIB Non-Small Cell Lung Cancer"; Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - erbitux-ib13-esr336-fu01.pdf - erbitux-ib13-esr340-fu01.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 21, 2009 SUBJECT: RTOG Registration Desk Closure The RTOG Registration Desk will be closed for the Memorial Day holiday, Friday May 22nd at 3PM EST and will remain closed Monday, May 25th. We will reopen on Tuesday, May 26th at 8:30AM EST. Sites may access web registration 24/7. Please notify your affiliates that are not on e-mail. DATE: May 20, 2009 SUBJECT: RTOG eNews: RTOG 0436 Featured Trial in NCI Bulletin & RTOG 0625 Completes Accrual RTOG eNews May 20, 2009 RTOG 0436 Featured in the NCI Cancer Bulletin RTOG 0436, A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery, is the featured clinical trial in the current issue of the NCI Cancer Bulletin. The article is available at http://www.cancer.gov/ncicancerbulletin/051909/page7. Thank You to RTOG 0625 Accruing Sites RTOG is pleased to announce that accrual has been completed for the joint RTOG/ACRIN protocol, A Randomized Phase II Trial of Bevacizumab with Irinotecan or Bevacizumab with Temozolomide in Recurrent Glioblastoma. The trial closed to accrual on May 18th with a total enrollment of 123 participants. The trial's primary aim is to determine whether the drug bevacizumab, in combination with either temozolomide or irinotecan, is effective in treating glioblastoma. RTOG is the lead group for this joint study with ACRIN. Thank you to all who helped enroll patients on this study. Accruing Sites to RTOG 0625/ACRIN 6677 Inst Name Accrual Henry Ford Hospital 22 University of Texas-MD Anderson Cancer Center 18 Tel-Aviv Medical Center 13 University of Chicago 12 LDS Hospital 9 Washington University 7 Memorial Sloan Kettering Cancer Center 6 Carolinas Medical Center 6 Virginia Mason CCOP 5 St. Luke's Mountain States Tumor Institute 5 Anne Arundel Medical Center 3 Medical College of Wisconsin 3 Thomas Jefferson University Hospital 2 University of Iowa Hospitals and Clinics 2 Akron General Medical Center 2 Saint John's Health System Cancer Center 1 University of Rochester 1 John Muir Medical Center - Concord Campus 1 Arizona Oncology Services Foundation 1 Northern Rockies Radiation Oncology Center 1 John F. Kennedy Medical Center 1 Yale Cancer Center 1 Alta Bates Hospital Comprehensive Cancer Center 1 TOTAL 123 Contact Us If you need further information about articles in the RTOG Newsletter please send an e-mail to shartson@acr-arrs.org. RTOG's clinical trials are available at http://www.rtog.org/members/active.html. More information is available on the Web at http://www.rtog.org DATE: May 20, 2009 SUBJECT: RTOG (0411), 0417,(0615), 0625, & 0825 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety report(s) from NCI for BEVACIZUMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by the NCI. The Following RTOG studies involve BEVACIZUMAB: RTOG (0411) "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417 "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG (0615) "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" RTOG 0825, "Phase III Double-Blind Placebo-Controlled Trial of Conventional Concurrent Chemoradiation and Adjuvant Temozolomide Plus Bevacizumab Versus Conventional Concurrent Chemoradiation and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - Bevacizumab,AE-1833568, Protocol E5103, -ISR.PDF Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 19, 2009 SUBJECT: RTOG 0825 Reimbursement for Bevacizumab Infusion Attached please find a notice regarding reimbursement for the bevacizumab infusion for RTOG 0825. Thank you for sharing this email with your affiliate institutions that are not included in the mailing distribution list. RTOG0825 Bevacizumab Infusion Reimbursement 01May09.pdf DATE: May 19, 2009 SUBJECT: RTOG 0614 and 0825: New Temporary Web Link for the Neurocognitive Tests New Temporary Web Link for Neurocognitive Tests - RTOG 0614 and 0825 MD Anderson Cancer Center has changed its entire web site and the web page for the training video of neurocognitive tests has been relocated temporarily. The new link is available in the "Neurocognitive Training Procedure Letter" posted along with neurocognitive tests on the RTOG website. When a new permanent web site is established, the definitive link for neurocognitive tests will be broadcast. Thank you for sharing this email with your affiliate institutions that are not included in the mailing distribution list. DATE: May 19, 2009 SUBJECT: RTOG 0625/ACRIN 6677, Closure Notice Closure Notice RTOG 0625/ACRIN 6677, "A Randomized Phase II Trial of Bevacizumab With Irinotecan or Bevacizumab With Temozolomide in Recurrent Glioblastoma," will close to patient accrual at 5 PM EST today, Tuesday, May 19, because the study has met its primary accrual objective. (Notice of this closure was previously broadcast on 5/12/09.) Please notify your affiliates who are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Sites should not contact Michelle Buado for any other reason or reply directly to this broadcast. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. DATE: May 18, 2009 SUBJECT: RTOG 0247 & 0822 Protocol Notice: OXALIPLATIN IND-SAFETY REPORT RTOG has received safety report(s) from Sanofi-Aventis and/or NCI for Oxaliplatin. The following RTOG study involves Oxaliplatin: RTOG 0247, "Randomized Phase II Trial of Neoadjuvant Combined Modality Therapy for Locally Advanced Rectal Cancer." RTOG 0822, "A Phase II Evaluation of Preoperative Chemoradiotherapy Utilizing Intensity Modulated Radiation Therapy (IMRT) in Combination With Capecitabine and Oxaliplatin for Patients With Locally Advanced Rectal Cancer" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - Oxaliplatin, AE-1265048, Protocol N0147, -ISR.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 18, 2009 SUBJECT: RTOG (0324), (0234), (0522), 0436, & 0617 PROTOCOL NOTICE: BMS, ImClone and/or NCI SAFETY REPORTS FOR CETUXIMAB RTOG has received safety report(s) from BMS, ImClone, and/or NCI for CETUXIMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by BMS, ImClone, and/or NCI. The Following RTOG studies involve CETUXIMAB: RTOG (0324) "A PHASE II STUDY OF CETUXIMAB (C225) IN COMBINATION WITH CHEMORADIATION IN PATIENTS WITH STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC)" RTOG (0234) "A PHASE II RANDOMIZED TRIAL OF SURGERY FOLLOWED BY CHEMORADIOTHERAPY PLUS C225 (CETUXIMAB) FOR ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK" RTOG (0522) "A PHASE III TRIAL OF CONCURRENT ACCELERATED RADIATION AND CISPLATIN VERSUS CONCURRENT ACCELERATED RADIATION, CISPLATIN, AND CETUXIMAB (C225) FOLLOWED BY SURGERY FOR RESIDUAL DISEASE FOR STAGE III AND IV HEAD AND NECK CARCINOMAS" RTOG 0436, "A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery" RTOG 0617/NCCTG N0628/CALGB 30609/ECOG R0617, "A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy with Concurrent and Consolidation Carboplatin/Paclitaxel +/-Cetuximab (IND#103444) in Patients with Stage IIIA/IIIB Non-Small Cell Lung Cancer"; Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - erbitux-ib13-esr340.pdf - erbitux-ib13-esr310-fu02.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 18, 2009 SUBJECT: RTOG (0411), 0417,(0615), 0625, & 0825 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety report(s) from NCI for BEVACIZUMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by the NCI. The Following RTOG studies involve BEVACIZUMAB: RTOG (0411) "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417 "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG (0615) "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" RTOG 0825, "Phase III Double-Blind Placebo-Controlled Trial of Conventional Concurrent Chemoradiation and Adjuvant Temozolomide Plus Bevacizumab Versus Conventional Concurrent Chemoradiation and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - Bevacizumab Oxaliplatin AE-1201753 Protocol E5204 -FU1.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 18, 2009 SUBJECT: RTOG eNews: RTOG 0235/ACRIN 6668 Completes Accrual RTOG eNews May 18, 2009 Thank You to RTOG 0235 Accruing Sites RTOG is pleased to announce that accrual has been completed for the joint RTOG/ACRIN protocol, Positron Emission Tomography Pre- and Post-treatment Assessment for Locally Advanced Non-small Cell Lung Carcinoma. The trial closed to accrual on May 15th with a total enrollment of 251 participants. The trial's primary aim is to determine if the standard uptake value (SUV) measurement from FDG-PET imaging shortly after treatment is a useful predictor of long-term clinical outcome (survival) after definitive chemoradiotherapy. Thank you to all who played a role in meeting this significant trial milestone. Accruing Sites to RTOG 0235/ACRIN 6668 Inst Name Accrual LIMR/MLH CCOP 33 National Cancer Center Korea 28 Florida Radiation Oncology Group / Baptist Regional 24 Washington University 15 Cleveland Clinic Foundation 14 UPMC-Shadyside Hospital 12 University of Texas-MD Anderson Cancer Center 11 Community Medical Center 10 University of Texas Southwestern Medical School 9 Fox Chase Cancer Center 8 Beaumont CCOP 8 Scottsdale Radiation Oncology Centers-Shea Center 7 Dartmouth Hitchcock Medical Center 7 Saint John's Health System Cancer Center 6 Tom Baker Cancer Centre 6 Medical University of South Carolina 5 University of Southern California-Los Angeles 5 West Michigan Cancer Center CCOP 4 Thomas Jefferson University Hospital 4 University of Alabama at Birmingham Medical Center 4 Hospital of St. Raphael 3 Vanderbilt University Medical Center 3 University of Colorado Denver 3 Medical College of Wisconsin 3 University of Iowa Hospitals and Clinics 2 Memorial & St. Elizabeth's Healthcare Services, LLP 2 Holy Name Hospital 2 Akron General Medical Center 2 South Suburban Oncology Center 2 University of Utah Health Science Center 2 Nevada Cancer Research Foundation 1 North Broward Medical Center - Cancer Center 1 Tallahassee Memorial Hospital 1 St. Mary's Hospital 1 Radiological Associates of Sacramento 1 Waukesha Memorial Hospital 1 Lifespan 1 TOTAL 251 Contact Us If you need further information about articles in the RTOG Newsletter please send an e-mail to shartson@acr-arrs.org. RTOG's clinical trials are available at http://www.rtog.org/members/active.html. More information is available on the Web at http://www.rtog.org DATE: May 15, 2009 SUBJECT: RTOG 0235/ACRIN 6668, Closure RTOG sites participating in RTOG 0235/ACRIN 6668, "Positron Emission Tomography Pre- and Post-treatment Assessment for Locally Advanced Non-small Cell Lung Cancer" , RTOG has received the following information from ACRIN (the coordinating group): "ACRIN 6668 / RTOG 0235 protocol will close to accrual on Friday, May 15, 2009 due to successful completion of study accrual. Access to the ACRIN 6668 web registration module (A0 Form) will be discontinued as of 5 pm EDT, May 15, 2009. Please review the attached accrual closure memo." RTOG sites should direct any questions or concerns to Irene Mahon, RN, MPH, Project Manager, ACRIN Thoracic Protocols, 215-574-3249. Please notify your affiliates that are not on e-mail. DATE: May 14, 2009 SUBJECT: RTOG Semiannual Meeting Registration and Attendee Information This is reminder: The upcoming RTOG meeting is fast approaching, please remember to complete the online registration and make your hotel reservations in advance. RTOG eNews April 1, 2009 RTOG Semiannual Meeting Registration & Attendee Information Radiation Therapy Oncology Group Semiannual Meeting Chicago Marriott Downtown Magnificent Mile June 25 - 28, 2009 Highlights include: Research Associates Orientation Program on Thursday, June 25th RTOG 0825 Kick-Off Reception on Friday, June 26th: Phase III Double-Blind Placebo-Controlled Trial of Conventional Concurrent Chemoradiation and Adjuvant Temozolomide plus Bevacizumab Versus Conventional Concurrent Chemoradiation and Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma RTOG Symposium on Friday, June 26th: Globalization of RTOG Research Information about the meeting, including the agenda, the link for online registration, and the meeting brochure, is now available on the RTOG Web site (http://www.rtog.org/meeting/main.html). Please take advantage of the opportunity to complete your meeting registration in advance via the web. We also encourage you to book your hotel and travel accommodations early. Contact Us If you need further information or wish to be added to or removed from our mailing list please send an e-mail to Sharon Hartson Stine at: shartson@acr-arrs.org. RTOG's clinical trials are available at http://www.rtog.org/members/active.html. More information is available on the Web at www.rtog.org. DATE: May 14, 2009 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0229 WEB-BASED ELECTRONIC DATA SUBMISSION IS NOW AVAILABLE FOR RTOG # 0229 LUNG F1 Follow-Up Form Per previous Broadcasts, web-based data submission became mandatory as of May 14, 2007 for all forms available for web-entry for all cases. A complete listing of forms available for web data submission is available at http://www.rtog.org/members/webreg.html For technical support with web data submission, please email websupport@acr-arrs.org. Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214. Forms received in paper format after June 15, 2009 will be returned to the site for transcription. Please notify your joint center institutions and affiliates who are not on e-mail. Mary Gramkowski, RN, B.A., C.C.R.P. RTOG Data Management Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 14, 2009 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0212 Web-based Electronic Data Submission Is Now Available For RTOG # 0212 LUNG F1 Follow-Up Form Per previous Broadcasts, web-based data submission became mandatory as of May 14, 2007 for all forms available for web-entry. Web entry will be required for all cases enrolled through RTOG after January 1, 2006. This pertains to case numbers 147 through 267. A complete listing of forms available for web data submission is available at http://www.rtog.org/members/webreg.html For technical support with web data submission, please email websupport@acr-arrs.org. Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214. Forms received in paper format after June 15, 2009 will be returned to the site for transcription. Please notify your joint center institutions and affiliates who are not on e-mail. Mary Gramkowski, RN, B.A., C.C.R.P. RTOG Data Management Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 13, 2009 SUBJECT: RTOG (0411), 0417,(0615), 0625, & 0825 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety report(s) from NCI for BEVACIZUMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by the NCI. The Following RTOG studies involve BEVACIZUMAB: RTOG (0411) "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417 "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG (0615) "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" RTOG 0825, "Phase III Double-Blind Placebo-Controlled Trial of Conventional Concurrent Chemoradiation and Adjuvant Temozolomide Plus Bevacizumab Versus Conventional Concurrent Chemoradiation and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - Bevacizumab, AE-1293580, Protocol GOG-0218, -ISR.pdf - Bevacizumab, AE-1836781, Protocol GOG-0218, -ISR.pdf - Bevacizumab,AE-1419144, Protocol E5103, -ISR.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 12, 2009 SUBJECT: RTOG 0625/ACRIN 6677, Closure Notice Closure Notice RTOG 0625/ACRIN 6677, "A Randomized Phase II Trial of Bevacizumab With Irinotecan or Bevacizumab With Temozolomide in Recurrent Glioblastoma," will close to patient accrual at 5 PM EST Tuesday, May 19, because the study has met its primary accrual objective. Please notify your affiliates who are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Sites should not contact Michelle Buado for any other reason or reply directly to this broadcast. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. DATE: May 11, 2009 SUBJECT: RTOG 0614: Neurocognitive and Quality of Life Assessments RTOG 0614 Neurocognitive and Quality of Life Assessments Per statistical guidelines and to satisfy the protocol endpoints, MS, NP, PQ and QL forms need to be submitted for each specific time point as outlined in section 12.0 of the protocol. If protocol treatment is discontinued before completion, neurocognitive and quality of life assessments still must be done if the patient is willing to participate. The cover sheet for each time point must be submitted regardless of whether the form was completed. Please indicate the time point missed and submit the cover sheet of the corresponding form indicating the reason why the test was not done. Thank you for your assistance in this matter. Sandrine Geinoz, PhD, CCRP RTOG Research Associate Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 11, 2009 SUBJECT: RTOG (0324), (0234), (0522), 0436, & 0617 PROTOCOL NOTICE: BMS, ImClone and/or NCI SAFETY REPORTS FOR CETUXIMAB RTOG has received safety report(s) from BMS, ImClone, and/or NCI for CETUXIMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by BMS, ImClone, and/or NCI. The Following RTOG studies involve CETUXIMAB: RTOG (0324) "A PHASE II STUDY OF CETUXIMAB (C225) IN COMBINATION WITH CHEMORADIATION IN PATIENTS WITH STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC)" RTOG (0234) "A PHASE II RANDOMIZED TRIAL OF SURGERY FOLLOWED BY CHEMORADIOTHERAPY PLUS C225 (CETUXIMAB) FOR ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK" RTOG (0522) "A PHASE III TRIAL OF CONCURRENT ACCELERATED RADIATION AND CISPLATIN VERSUS CONCURRENT ACCELERATED RADIATION, CISPLATIN, AND CETUXIMAB (C225) FOLLOWED BY SURGERY FOR RESIDUAL DISEASE FOR STAGE III AND IV HEAD AND NECK CARCINOMAS" RTOG 0436, "A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery" RTOG 0617/NCCTG N0628/CALGB 30609/ECOG R0617, "A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy with Concurrent and Consolidation Carboplatin/Paclitaxel +/-Cetuximab (IND#103444) in Patients with Stage IIIA/IIIB Non-Small Cell Lung Cancer"; Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - erbitux-ib13-esr337-fu01.pdf - erbitux-ib13-esr329-fu01.pdf - erbitux-ib13-esr339.pdf - erbitux-ib13-esr325-fu02.pdf - erbitux-ib13-esr316-fu01.pdf - erbitux-ib13-esr334-fu01.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 11, 2009 SUBJECT: RTOG (0411), 0417,(0615), 0625, & 0825 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety report(s) from NCI for BEVACIZUMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by the NCI. The Following RTOG studies involve BEVACIZUMAB: RTOG (0411) "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417 "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG (0615) "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" RTOG 0825, "Phase III Double-Blind Placebo-Controlled Trial of Conventional Concurrent Chemoradiation and Adjuvant Temozolomide Plus Bevacizumab Versus Conventional Concurrent Chemoradiation and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - Bevacizumab,AE-1329128, Protocol E5103, -ISR.pdf - Bevacizumab,AE-1391765, Protocol E1505, -ISR.pdf - Bevacizumab, AE-1133874, Protocol E1505, -ISR.PDF Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 11, 2009 SUBJECT: RTOG 0614 & 0825 Neurocognitive Assessment Forms - Trail Making Tests RTOG 0614 & 0825 - Trail Making Test Data Sheets Please Note: The trail making test data sheets for both of the above studies have been corrected. The instructions for the Trail Making Test Part B, Question 3(highlighted) have been corrected to read 5 minutes instead of 3 minutes (see below)and the corrected version has been posted on the RTOG web site. Trail Making Test Part B: 1. Did the patient do Sample B before attempting Part B? ☐ Yes ☐ No 2. Total amount of time the patient was tested: ____ : ____ ____(min:sec) 3. Did the patient reach the "END" of the test? ☐Yes ☐ No, tested for 5 minutes OR ☐ No, tested for <5 minutes If No, specify the last number/letter reached on the test: ____ Please notify your joint center institutions and affiliates who are not on e-mail. DATE: May 7, 2009 SUBJECT: RTOG 0618 and 0813, Updated Updated RTOG 0618, "A Phase II Trial of Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Patients with Operable Stage I/II Non-Small Cell Lung Cancer" and RTOG 0813, "Seamless Phase I/II Study of Stereotactic Lung Radiotherapy (SBRT) for Early Stage, Centrally Located, Non-Small Cell Lung Cancer (NSCLC) in Medically Inoperable Patients" At the request of the RTOG Biospecimen Resource and the Translational Research Co-Chair, Dr. Kong, the logistics for submission of specimens in each of these studies have been updated. Sites can access the complete summary of changes for each study at http://www.rtog.org/members/protocols/0618/summary_changes.html and http://www.rtog.org/members/protocols/0813/summary_changes.html Sites can download a copy of each protocol for IRB review at http://www.rtog.org/members/protocols/0618/0618.pdf and http://www.rtog.org/members/protocols/0813/0813.pdf The "Update Date" on the protocol title page indicates that editorial/administrative changes were made to the protocol. For clarity, the broadcast date of the update is provided in parentheses on each summary of change. IRB review of an update is not required; however, these changes must be reported to site IRBs. Please notify your affiliates that are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, please e-mail mbuado@acr-arrs.org. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. DATE: May 4, 2009 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0712 WEB-BASED ELECTRONIC DATA SUBMISSION UPDATE: RTOG 0712 A Phase II Randomized Study For Patients With Muscle-Invasive Bladder Cancer Evaluating Transurethral Surgery And Concomitant Chemoradiation By Either BID Irradiation Plus 5-Fluorouracil And Cisplatin Or QD Irradiation Plus Gemcitabine Followed By Selective Bladder Preservation And Gemcitabine/Cisplatin Adjuvant Chemotherapy Web-Based Electronic Data Submission is now available for the following forms: RTOG 0712 AF form (Treatment Summary Form-Adjuvant) RTOG 0712 S1 form (Surgical Form) Per previous Broadcasts, web-based data submission became mandatory as of May 14, 2007 for all forms available for web-entry for all cases enrolled through RTOG. A complete listing of forms available for web data submission is available at http://www.rtog.org/members/webreg.html For technical support with web data submission, please email websupport@acr-arrs.org Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214. Elaine Motyka-Welsh, RN, MSN, CCRP Research Associate DATE: May 1, 2009 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0415 EB-BASED ELECTRONIC DATA SUBMISSION UPDATE: RTOG 0415 A PHASE III RANDOMIZED STUDY OF HYPOFRACTIONATED 3D-CRT/IMRT VERSUS CONVENTIONALLY FRACTIONATED 3D-CRT/IMRT IN PATIENTS WITH FAVORABLE-RISK PROSTATE CANCER Web-Based Electronic Data Submission is now available for the following form: RTOG 0415 AE (Adverse Event Form) PLEASE NOTE: This form will be available for web entry after you submit the form (T1 or F1) that reports there are new or continuing adverse events to report. You will need to go back to the data collection calendar and select the AE form that was populated on the calendar. The due date that is populated for the AE form will be one week after the due date of the recently submitted form (i.e. T1 due date or F1 due date). Per previous Broadcasts, web-based data submission became mandatory as of May 14, 2007 for all forms available for web-entry for all cases enrolled through RTOG. A complete listing of forms available for web data submission is available at http://www.rtog.org/members/webreg.html Any paper AE forms received after 5/15/09 will be returned to the institution for web entry. For technical support with web data submission, please email websupport@acr-arrs.org Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214. Elaine Motyka-Welsh, RN, MSN, CCRP Research Associate DATE: May 1, 2009 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0521 WEB-BASED ELECTRONIC DATA SUBMISSION UPDATE: RTOG 0521 A PHASE III PROTOCOL OF ANDROGEN SUPPRESSION (AS) AND 3DCRT/IMRT VS AS AND 3DCRT/IMRT FOLLOWED BY CHEMOTHERAPY WITH DOCETAXEL AND PREDNISONE FOR LOCALIZED, HIGH-RISK PROSTATE CANCER Web-Based Electronic Data Submission is now available for the following form: RTOG 0521 AE (Adverse Event Form) PLEASE NOTE: This form will be available for web entry after you submit the form ** (T1, TF, F0, FS or F1) that reports there are new or continuing adverse events to report. You will need to go back to the data collection calendar and select the AE form that was populated on the calendar. The due date that is populated for the AE form will be one week after the due date of the recently submitted form (i.e. TF due date, F1 due date, etc.). **If there is more than one form due during the same time frame and they share the same assessed date, please submit only one AE form reporting all adverse events experienced during the report period (i.e. only one form will report that there are new or continuing adverse events to report). Per previous Broadcasts, web-based data submission became mandatory as of May 14, 2007 for all forms available for web-entry for all cases enrolled through RTOG. A complete listing of forms available for web data submission is available at http://www.rtog.org/members/webreg.html Any paper AE forms received after 5/15/09 will be returned to the institution for web entry. For technical support with web data submission, please email websupport@acr-arrs.org Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214. Elaine Motyka-Welsh, RN, MSN, CCRP Research Associate DATE: April 30, 2009 SUBJECT: RTOG 0630, Amended Amended RTOG 0630, "A Phase II Trial of Image Guided Preoperative Radiotherapy for Primary Soft Tissue Sarcomas of the Extremity", Amendment 2: Subsections of Section 6.0 were clarified and changes were made to Appendices I and II. Sites can access the complete summary of changes at http://www.rtog.org/members/protocols/0630/summary_changes.html Sites can download a copy of the amended protocol by accessing the RTOG web site at http://www.rtog.org/members/protocols/0630/0630.pdf NCI policy requires that the "Version Date" on the protocol title page reflect the date the amendment was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses. Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. Please notify your affiliates that are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, please e-mail mbuado@acr-arrs.org. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. DATE: April 30, 2009 SUBJECT: RTOG (0324), (0234), (0522), 0436, & 0617 PROTOCOL NOTICE: BMS, ImClone and/or NCI SAFETY REPORTS FOR CETUXIMAB RTOG has received safety report(s) from BMS, ImClone, and/or NCI for CETUXIMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by BMS, ImClone, and/or NCI. The Following RTOG studies involve CETUXIMAB: RTOG (0324) "A PHASE II STUDY OF CETUXIMAB (C225) IN COMBINATION WITH CHEMORADIATION IN PATIENTS WITH STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC)" RTOG (0234) "A PHASE II RANDOMIZED TRIAL OF SURGERY FOLLOWED BY CHEMORADIOTHERAPY PLUS C225 (CETUXIMAB) FOR ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK" RTOG (0522) "A PHASE III TRIAL OF CONCURRENT ACCELERATED RADIATION AND CISPLATIN VERSUS CONCURRENT ACCELERATED RADIATION, CISPLATIN, AND CETUXIMAB (C225) FOLLOWED BY SURGERY FOR RESIDUAL DISEASE FOR STAGE III AND IV HEAD AND NECK CARCINOMAS" RTOG 0436, "A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery" RTOG 0617/NCCTG N0628/CALGB 30609/ECOG R0617, "A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy with Concurrent and Consolidation Carboplatin/Paclitaxel +/-Cetuximab (IND#103444) in Patients with Stage IIIA/IIIB Non-Small Cell Lung Cancer"; Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - erbitux-ib13-esr331-fu01.pdf - erbitux-ib13-esr335-fu01.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 29, 2009 SUBJECT: RTOG 0320 PROTOCOL NOTICE: NCI SAFETY REPORT for ERLOTINIB RTOG has received safety report(s) from the NCI/NIH for Erlotinib the Following RTOG study(s) involve Erlotinib: Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by the NCI. RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR ERLOTINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - OSI-774, Investigator Notification, OSI Pharmaceuticals Report 2009000831, April 24, 2009.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 28, 2009 SUBJECT: RTOG (0324), (0234), (0522), 0436, & 0617 PROTOCOL NOTICE: BMS, ImClone and/or NCI SAFETY REPORTS FOR CETUXIMAB RTOG has received safety report(s) from BMS, ImClone, and/or NCI for CETUXIMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by BMS, ImClone, and/or NCI. The Following RTOG studies involve CETUXIMAB: RTOG (0324) "A PHASE II STUDY OF CETUXIMAB (C225) IN COMBINATION WITH CHEMORADIATION IN PATIENTS WITH STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC)" RTOG (0234) "A PHASE II RANDOMIZED TRIAL OF SURGERY FOLLOWED BY CHEMORADIOTHERAPY PLUS C225 (CETUXIMAB) FOR ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK" RTOG (0522) "A PHASE III TRIAL OF CONCURRENT ACCELERATED RADIATION AND CISPLATIN VERSUS CONCURRENT ACCELERATED RADIATION, CISPLATIN, AND CETUXIMAB (C225) FOLLOWED BY SURGERY FOR RESIDUAL DISEASE FOR STAGE III AND IV HEAD AND NECK CARCINOMAS" RTOG 0436, "A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery" RTOG 0617/NCCTG N0628/CALGB 30609/ECOG R0617, "A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy with Concurrent and Consolidation Carboplatin/Paclitaxel +/-Cetuximab (IND#103444) in Patients with Stage IIIA/IIIB Non-Small Cell Lung Cancer"; Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - erbitux-ib13-esr337.pdf - erbitux-ib13-esr336.pdf - erbitux-ib13-esr338.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 28, 2009 SUBJECT: RTOG 0436 Section 6 Clarification Investigators participating in RTOG 0436, "A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients with Esophageal Cancer Who Are Treated without Surgery" Please note the following specific radiation therapy planning clarifications, which were added in amendment # 1, version February 13, 2009 (broadcast 3/31/09): SECTION 6.0: "All doses are to be prescribed and calculated assuming a homogeneous patient." SECTION 6.5.2: "All normal tissues assume treatment at 1.8 Gy/ Fx (uncorrected). There will be no heterogeneity corrections used in the definitions of these doses." DATE: April 27, 2009 SUBJECT: Endorsed, SWOG S0809 The following study has been endorsed by the Radiation Therapy Oncology Group and its Gastrointestinal Committee: SWOG S0809, "A Phase II Trial of Adjuvant Capecitabine/Gemcitabine Chemotherapy Followed by Concurrent Capecitabine and Radiotherapy in Extrahepatic Cholangiocarcinoma (EHCC)" RTOG Co-Chair: Laura A. Dawson, MD, University of Toronto, 416-946-2124, Laura.Dawson@rmp.uhn.on.ca Enrollment procedures and data collection for this study must be done via the Clinical Trials Support Unit (CTSU). The enrolling investigator must be a CTSU member investigator. Investigator registration, credentialing information, and the protocol can be accessed at http://www.ctsu.org RTOG institutions that enter patients on any CTSU trial can receive credit toward RTOG membership accrual requirements. The enrolling investigator must declare RTOG membership at the time of registration in order to receive RTOG credit. Please notify your affiliates who are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Sites should not contact Michelle Buado for any other reason or reply directly to this broadcast. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. DATE: April 27, 2009 SUBJECT: RTOG 0627 PROTOCOL NOTICE: BMS and/or NCI SAFETY REPORTS FOR DASATINIB RTOG has received safety report(s) from BMS and/or NCI for DASATINIB If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by BMS, ImClone, and/or NCI. The Following RTOG studies involve DASATINIB: RTOG 0627 "PHASE II TRIAL OF DASATINIB IN PATIENTS WITH RECURRENT GLIOBLASTOMA MULTIFORME" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - dasatinib-ib08-esr02-fu01.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 23, 2009 SUBJECT: RTOG (0411), 0417, 0615 & 0625 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety report(s) from NCI for BEVACIZUMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by the NCI. The Following RTOG studies involve BEVACIZUMAB: RTOG (0411) "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417 "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG 0615 "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - Bevacizumab CCI-779, AE-1034535, Protocol E2804, -FU1.pdf - Bevacizumab,AE-1314985, Protocol E5103, -ISR.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 22, 2009 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0712 WEB-BASED ELECTRONIC DATA SUBMISSION UPDATE: RTOG 0712 A Phase II Randomized Study For Patients With Muscle-Invasive Bladder Cancer Evaluating Transurethral Surgery And Concomitant Chemoradiation By Either BID Irradiation Plus 5-Fluorouracil And Cisplatin Or QD Irradiation Plus Gemcitabine Followed By Selective Bladder Preservation And Gemcitabine/Cisplatin Adjuvant Chemotherapy Web-Based Electronic Data Submission is now available for the following form: RTOG 0712 F0 (Post Treatment Evaluation Form) Per previous Broadcasts, web-based data submission became mandatory as of May 14, 2007 for all forms available for web-entry for all cases enrolled through RTOG. A complete listing of forms available for web data submission is available at http://www.rtog.org/members/webreg.html For technical support with web data submission, please email websupport@acr-arrs.org. Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214. Elaine Motyka-Welsh, RN, MSN, CCRP RTOG Data Management DATE: April 22, 2009 SUBJECT: RTOG (0324), (0234), (0522), 0436, & 0617 PROTOCOL NOTICE: BMS, ImClone and/or NCI SAFETY REPORTS FOR CETUXIMAB RTOG has received safety report(s) from BMS, ImClone, and/or NCI for CETUXIMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by BMS, ImClone, and/or NCI. The Following RTOG studies involve CETUXIMAB: RTOG (0324) "A PHASE II STUDY OF CETUXIMAB (C225) IN COMBINATION WITH CHEMORADIATION IN PATIENTS WITH STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC)" RTOG (0234) "A PHASE II RANDOMIZED TRIAL OF SURGERY FOLLOWED BY CHEMORADIOTHERAPY PLUS C225 (CETUXIMAB) FOR ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK" RTOG (0522) "A PHASE III TRIAL OF CONCURRENT ACCELERATED RADIATION AND CISPLATIN VERSUS CONCURRENT ACCELERATED RADIATION, CISPLATIN, AND CETUXIMAB (C225) FOLLOWED BY SURGERY FOR RESIDUAL DISEASE FOR STAGE III AND IV HEAD AND NECK CARCINOMAS" RTOG 0436, "A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery" RTOG 0617/NCCTG N0628/CALGB 30609/ECOG R0617, "A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy with Concurrent and Consolidation Carboplatin/Paclitaxel +/-Cetuximab (IND#103444) in Patients with Stage IIIA/IIIB Non-Small Cell Lung Cancer"; Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - erbitux-ib13-esr328-fu01.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 21, 2009 SUBJECT: QOL Forms - MMSE, HVLT and/or COWA Forms are now Password-Protected QOL Forms – MMSE, HVLT and/or COWA FORMS ARE NOW PASSWORD-PROTECTED Your user name and password will be required to access all applicable studies that use these QOL tools. Psychological Assessment Resource, Inc., who owns the copyright for these three QOL forms, has mandated that a user name and password be required in order to access them. Also, since the forms packet is set up as one pdf. file, a user name and password will need to be utilized to access any forms packet containing the MMSE, HVLT and/or COWA forms. DATE: April 21, 2009 SUBJECT: RTOG (0411), 0417, 0615 & 0625 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety report(s) from NCI for BEVACIZUMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by the NCI. The Following RTOG studies involve BEVACIZUMAB: RTOG (0411) "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417 "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG 0615 "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - Bevacizumab,AE-1809441, Protocol E5103, -ISR.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 20, 2009 SUBJECT: RTOG (0324), (0234), (0522), 0436, & 0617 PROTOCOL NOTICE: BMS, ImClone and/or NCI SAFETY REPORTS FOR CETUXIMAB RTOG has received safety report(s) from BMS, ImClone, and/or NCI for CETUXIMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by BMS, ImClone, and/or NCI. The Following RTOG studies involve CETUXIMAB: RTOG (0324) "A PHASE II STUDY OF CETUXIMAB (C225) IN COMBINATION WITH CHEMORADIATION IN PATIENTS WITH STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC)" RTOG (0234) "A PHASE II RANDOMIZED TRIAL OF SURGERY FOLLOWED BY CHEMORADIOTHERAPY PLUS C225 (CETUXIMAB) FOR ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK" RTOG (0522) "A PHASE III TRIAL OF CONCURRENT ACCELERATED RADIATION AND CISPLATIN VERSUS CONCURRENT ACCELERATED RADIATION, CISPLATIN, AND CETUXIMAB (C225) FOLLOWED BY SURGERY FOR RESIDUAL DISEASE FOR STAGE III AND IV HEAD AND NECK CARCINOMAS" RTOG 0436, "A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery" RTOG 0617/NCCTG N0628/CALGB 30609/ECOG R0617, "A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy with Concurrent and Consolidation Carboplatin/Paclitaxel +/-Cetuximab (IND#103444) in Patients with Stage IIIA/IIIB Non-Small Cell Lung Cancer"; Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - erbitux-ib13-esr335.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 16, 2009 SUBJECT: RTOG (0324), (0234), (0522), 0436, & 0617 PROTOCOL NOTICE: BMS, ImClone and/or NCI SAFETY REPORTS FOR CETUXIMAB RTOG has received safety report(s) from BMS, ImClone, and/or NCI for CETUXIMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by BMS, ImClone, and/or NCI. The Following RTOG studies involve CETUXIMAB: RTOG (0324) "A PHASE II STUDY OF CETUXIMAB (C225) IN COMBINATION WITH CHEMORADIATION IN PATIENTS WITH STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC)" RTOG (0234) "A PHASE II RANDOMIZED TRIAL OF SURGERY FOLLOWED BY CHEMORADIOTHERAPY PLUS C225 (CETUXIMAB) FOR ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK" RTOG (0522) "A PHASE III TRIAL OF CONCURRENT ACCELERATED RADIATION AND CISPLATIN VERSUS CONCURRENT ACCELERATED RADIATION, CISPLATIN, AND CETUXIMAB (C225) FOLLOWED BY SURGERY FOR RESIDUAL DISEASE FOR STAGE III AND IV HEAD AND NECK CARCINOMAS" RTOG 0436, "A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery" RTOG 0617/NCCTG N0628/CALGB 30609/ECOG R0617, "A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy with Concurrent and Consolidation Carboplatin/Paclitaxel +/-Cetuximab (IND#103444) in Patients with Stage IIIA/IIIB Non-Small Cell Lung Cancer"; Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - erbitux-ib13-esr332.pdf - erbitux-ib13-esr334.pdf - erbitux-ib13-esr333.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 16, 2009 SUBJECT: RTOG 0627 PROTOCOL NOTICE: BMS and/or NCI SAFETY REPORTS FOR DASATINIB RTOG has received safety report(s) from BMS and/or NCI for DASATINIB If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by BMS, ImClone, and/or NCI. The Following RTOG studies involve DASATINIB: RTOG 0627 "PHASE II TRIAL OF DASATINIB IN PATIENTS WITH RECURRENT GLIOBLASTOMA MULTIFORME" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - dasatinib-ib08-esr02.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 15, 2009 SUBJECT: RTOG eNews: RTOG Opens Phase III Trial of Temozolomide and Radiotherapy Plus Bevacizumab for Newly Diagnosed Glioblastoma Tumors RTOG eNews April 15, 2009 RTOG Opens New Phase III Trial for Glioblastoma Tumors RTOG has opened a new phase III trial for patients with newly diagnosed glioblastoma (GBM) to determine if the addition of bevacizumab to the current standard-of-care therapy, concurrent chemoradiation and adjuvant temozolomide, improves patient outcomes "Prior studies have shown that patients with methylated MGMT are more likely to respond to temozolomide-based therapy. Since encouraging response rates have been demonstrated in phase II trials of Avastin for treatment in patients with recurrent glioblastoma, we designed this trial as a natural progression to evaluate the benefits of the combination therapy in newly diagnosed GBM," said Mark R. Gilbert, MD, the study's principal investigator and professor of neuro-oncology at the University of Texas M.D. Anderson Cancer Center. "The goal of RTOG 0825 is to demonstrate improvements in progression-free and overall survival in all GBM patients being treated with the combination therapy versus temozolomide/radiation therapy alone." Patients enrolled in the new trial, RTOG 0825, will have histologic confirmation and analysis of their MGMT status through central pathology review after registration on the study but prior to treatment assignment. All patients will receive standard therapy of radiation and daily temozolomide for three weeks. Patients will then be stratified by MGMT methylation status and molecular profile to receive either standard therapy plus bevacizumab or a continuation of their standard therapy plus placebo. RTOG investigators will examine progression-free and overall survival rates, tumor molecular profiles for prognostic factors, neurocognitive function, health-related quality of life, patient-reported outcomes, treatment side-effects, and the interactions between these factors. "This study is an exciting continuation of our pivotal research in glioblastoma. RTOG recently completed a study of standard versus dose-intensive temozolomide combined with radiotherapy for this patient group," said Walter J. Curran, Jr., M.D., the RTOG Group Chair, and the Lawrence W. Davis Professor and Chair of the Department of Radiation Oncology in the Emory School of Medicine and Chief Medical Officer of the Emory Winship Cancer Institute. "We rapidly accrued over 1000 patients to that study and we are looking forward to the enthusiastic support of the oncology community for this new study." RTOG 0825 will enroll 720 patients with histopathologically confirmed glioblastoma from RTOG member institutions in North America and internationally. Members of the North Central Cancer Treatment Group (NCCTG) and the Eastern Cooperative Oncology Group (ECOG) will also participate in this study. The protocol is available at: http://www.rtog.org/members/protocols/0825/0825.pdf. About Glioblastoma Multiforme (GBM) Brain Tumors GBM is the most aggressive and malignant form of glioma, a type of primary brain tumor. The annual incidence of GBM is four to five cases per 100,000 persons, with 25,000 to 28,000 new cases diagnosed each year in North America and Europe. About OncoMethylome Sciences' MGMT Assay The use of OncoMethylome's MGMT assay is based on studies that have shown that methylation (silencing) of the MGMT gene promoter may help to identify brain tumors more likely to respond to standard chemotherapeutic agents. Following treatment, GBM patients whose tumors are positive for MGMT gene promoter methylation have demonstrated improved overall survival when compared to patients with unmethylated or normally functioning MGMT. The MGMT assay was used in a retrospective analysis of a subset of GBM patients in a study published in The New England Journal of Medicine in March 2005 (N Engl J Med 2005; 532; 997-1003). Prospective confirmation of the predictive value of MGMT gene promoter methylation for the treatment with radiotherapy and temozolomide is currently ongoing within a large randomized international phase III trial (RTOG 0525-EORTC26052-22053). About Bevacizumab (Avastin ) Bevacizumab (Avastin ) is a biologic antibody designed to specifically inhibit the vascular endothelial growth factor (VEGF) protein that plays an important role in the development and maintenance of blood vessels, a process known as angiogenesis. Glioblastomas express high levels of VEGF and develop an extensive network of tumor blood vessels. VEGF is a potent activator of angiogenesis throughout the lifecycle of a tumor and is thought to be critical to a tumor's ability to grow beyond a few millimeters. Avastin is approved for the first- and second-line treatment of metastatic colorectal cancer in combination with intravenous 5-FU-based chemotherapy and for the first-line treatment of unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer (NSCLC) in combination with carboplatin and paclitaxel. Avastin is also approved, in combination with paclitaxel, for the treatment of patients who have not received chemotherapy for metastatic HER2-negative breast cancer. Please visit www.gene.com for full prescribing information, including Boxed WARNINGS, side effects, and important safety information. Contact Us If you need further information or wish to be added to or removed from our mailing list please send an e-mail to Sharon Hartson Stine at: shartson@acr-arrs.org. RTOG's clinical trials are available at http://www.rtog.org/members/active.html. More information is available on the Web at www.rtog.org. DATE: April 15, 2009 SUBJECT: RTOG 0825, Activated Activated RTOG 0825, "Phase III Double-Blind Placebo-Controlled Trial of Conventional Concurrent Chemoradiation and Adjuvant Temozolomide Plus Bevacizumab Versus Conventional Concurrent Chemoradiation and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma" Institutions can download a copy of the protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/forms/0825/main.html Forms for this study also are available on the RTOG web site at http://www.rtog.org/members/forms/0825/main.html Credit/Funding Notes: The study is approved for 1.0 treatment credits. Sites with patients participating in the quality of life/neurocognitive function component will receive 0.5 DCP cancer control credits per eligible patient registered. Sites will receive an additional $3000 per eligible patient registered, for a total of $5000 per patient. Regulatory Notes: NCI policy requires that the "Version Date" of the protocol reflect the date that the protocol was submitted by RTOG to NCI; therefore, the version date and the activation date on the protocol title page are not the same. The "Update Date" (the same as the activation date) indicates that administrative changes were made to the protocol after NCI approval; these changes are detailed in a summary of changes that can be accessed at http://www.rtog.org/members/protocols/0825/summary_changes.html Please notify your affiliates that are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, please e-mail rtogbroadcast@acr-arrs.org. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 15, 2009 SUBJECT: RTOG (0522) PROTOCOL NOTICE: CETUXIMAB Resupply Orders RTOG has received information from BMS regarding CETUXIMAB Resupply orders for RTOG 0522: RTOG (0522) "A PHASE III TRIAL OF CONCURRENT ACCELERATED RADIATION AND CISPLATIN VERSUS CONCURRENT ACCELERATED RADIATION, CISPLATIN, AND CETUXIMAB (C225) FOLLOWED BY SURGERY FOR RESIDUAL DISEASE FOR STAGE III AND IV HEAD AND NECK CARCINOMAS" Resupply orders for Cetuximab on RTOG 0522 must be sent to cetuximab.drug@bms.com. BMS will be unable to respond to orders sent to any other e-mail address. Please see attached contact information for the BMS Drug Supply Department and contact them directly with any drug distribution questions for RTOG 0522. Right-Click and Save As - CETUXIMAB ERBITUX CA225 SUPPLIES FROM BRISTOL-MYERS SQUIBB (Diane Calabro).vcf DATE: April 14, 2009 SUBJECT: RTOG (0324), (0234), (0522), 0436, & 0617 PROTOCOL NOTICE: BMS, ImClone and/or NCI SAFETY REPORTS FOR CETUXIMAB RTOG has received safety report(s) from BMS, ImClone, and/or NCI for CETUXIMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by BMS, ImClone, and/or NCI. The Following RTOG studies involve CETUXIMAB: RTOG (0324) "A PHASE II STUDY OF CETUXIMAB (C225) IN COMBINATION WITH CHEMORADIATION IN PATIENTS WITH STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC)" RTOG (0234) "A PHASE II RANDOMIZED TRIAL OF SURGERY FOLLOWED BY CHEMORADIOTHERAPY PLUS C225 (CETUXIMAB) FOR ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK" RTOG (0522) "A PHASE III TRIAL OF CONCURRENT ACCELERATED RADIATION AND CISPLATIN VERSUS CONCURRENT ACCELERATED RADIATION, CISPLATIN, AND CETUXIMAB (C225) FOLLOWED BY SURGERY FOR RESIDUAL DISEASE FOR STAGE III AND IV HEAD AND NECK CARCINOMAS" RTOG 0436, "A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery" RTOG 0617/NCCTG N0628/CALGB 30609/ECOG R0617, "A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy with Concurrent and Consolidation Carboplatin/Paclitaxel +/-Cetuximab (IND#103444) in Patients with Stage IIIA/IIIB Non-Small Cell Lung Cancer"; Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - erbitux-ib13-esr329.pdf - erbitux-ib13-esr328.pdf - erbitux-ib13-esr327.pdf - erbitux-ib13-esr325-fu01.pdf - erbitux-ib13-esr331.pdf - erbitux-ib13-esr330.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 14, 2009 SUBJECT:RTOG (0411), 0417, 0615 & 0625 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety report(s) from NCI for BEVACIZUMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by the NCI. The Following RTOG studies involve BEVACIZUMAB: RTOG (0411) "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417 "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG 0615 "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - Bevacizumab CC-5013, AE-1277486, Protocol 7313, -ISR.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 14, 2009 SUBJECT:RE-BROADCAST of RTOG 0534, Amended and Updated (previously broadcast March 31, 2009) *RE-BROADCAST-previously broadcast March 31, 2009* Amended and Updated RTOG 0534, "A Phase III Trial Of Short Term Androgen Deprivation With Pelvic Lymph Node Or Prostate Only Radiotherapy (SPPORT) In Prostate Cancer Patients With A Rising PSA After Radical Prostatectomy". Amendment #1: Revisions were made to protocol eligibility. Update: Participation in the neurocognitive testing is no longer mandatory for institutions. Institutions participating in the neurocognitive test battery must follow the certification process specified in the protocol. Sites can access the complete summary of changes for the amendment and the update at http://www.rtog.org/members/protocols/0534/summary_changes.html Sites can download a copy of the protocol for IRB review at http://www.rtog.org/members/protocols/0534/0534.pdf NCI policy requires that the "Version Date" on the protocol title page reflect the date the amendment was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses. Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. Expedited review is allowed; however, site IRB requirements take precedence. Please notify your affiliates who are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, please e-mail rtogbroadcast@acr-arrs.org. . Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html *RE-BROADCAST-previously broadcast March 31, 2009* DATE: April 13, 2009 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0712 WEB-BASED ELECTRONIC DATA SUBMISSION UPDATE: RTOG 0712 A Phase II Randomized Study For Patients With Muscle-Invasive Bladder Cancer Evaluating Transurethral Surgery And Concomitant Chemoradiation By Either BID Irradiation Plus 5-Fluorouracil And Cisplatin Or QD Irradiation Plus Gemcitabine Followed By Selective Bladder Preservation And Gemcitabine/Cisplatin Adjuvant Chemotherapy Web-Based Electronic Data Submission is now available for the following form: RTOG 0712 UR (Urodynamics Form) Per previous Broadcasts, web-based data submission became mandatory as of May 14, 2007 for all forms available for web-entry for all cases enrolled through RTOG. A complete listing of forms available for web data submission is available at http://www.rtog.org/members/webreg.html For technical support with web data submission, please email websupport@acr-arrs.org Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214. Elaine Motyka-Welsh, RN, MSN, CCRP RTOG Data Management DATE: April 9, 2009 SUBJECT: Statistical Analysis on RTOG 0525 ALL INSTITUTIONS PARTICIPATING IN RTOG 0525 An important statistical analysis is being planned on RTOG 0525. Please review your OPS tool and submit all outstanding data due through April 15th, 2009 to RTOG Headquarters by April 30th, 2009. Please notify your joint center institutions and affiliates who are not on e-mail. Thank you for your cooperation. Barbara Kaiser, RN, CCRP RTOG Data Management DATE: April 8, 2009 SUBJECT: RTOG (0411), 0417, 0615 & 0625 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety report(s) from NCI for BEVACIZUMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by the NCI. The Following RTOG studies involve BEVACIZUMAB: RTOG (0411) "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417 "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG 0615 "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - Bevacizumab CCI-779 AE-1994045 Protocol E2804 -ISR.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 8, 2009 SUBJECT: RTOG (0324), (0234), (0522), 0436, & 0617 PROTOCOL NOTICE: BMS, ImClone and/or NCI SAFETY REPORTS FOR CETUXIMAB RTOG has received safety report(s) from BMS, ImClone, and/or NCI for CETUXIMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by BMS, ImClone, and/or NCI. The Following RTOG studies involve CETUXIMAB: RTOG (0324) "A PHASE II STUDY OF CETUXIMAB (C225) IN COMBINATION WITH CHEMORADIATION IN PATIENTS WITH STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC)" RTOG (0234) "A PHASE II RANDOMIZED TRIAL OF SURGERY FOLLOWED BY CHEMORADIOTHERAPY PLUS C225 (CETUXIMAB) FOR ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK" RTOG (0522) "A PHASE III TRIAL OF CONCURRENT ACCELERATED RADIATION AND CISPLATIN VERSUS CONCURRENT ACCELERATED RADIATION, CISPLATIN, AND CETUXIMAB (C225) FOLLOWED BY SURGERY FOR RESIDUAL DISEASE FOR STAGE III AND IV HEAD AND NECK CARCINOMAS" RTOG 0436, "A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery" RTOG 0617/NCCTG N0628/CALGB 30609/ECOG R0617, "A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy with Concurrent and Consolidation Carboplatin/Paclitaxel +/-Cetuximab (IND#103444) in Patients with Stage IIIA/IIIB Non-Small Cell Lung Cancer"; Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - erbitux-ib13-esr321-fu02.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org ****Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments DATE: April 8, 2009 SUBJECT: Form Revision Notice - RTOG 0436 FORM REVISION RTOG 0436 A Phase III Trial Evaluating The Addition of Cetuximab To Paclitaxel, Cisplatin, And Radiation For Patients With Esophageal Cancer Who Are Treated Without Surgery The following form for this study has been revised. Download the new version from the RTOG web site at: http://www.rtog.org/pdf_forms.html?members/forms=0436/0436%20I1.pdf The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date I1 Initial Evaluation Form    I1a     04-08-09   Changes: Q#16- FNA (Fine Needle Aspiration) added to response “C” Q#18&19 Instructions updated Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions received after April 17, 2009 will be returned to the site for transcription. This form is currently available for web data submission Web-based data submission is mandatory for all forms that are available for web-entry for all cases enrolled through RTOG. A complete listing of all forms available for web-entry is available at: http://www.rtog.org/members/webreg.html For technical support with web data submission, please email websupport@acr-arrs.org. Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214. Please notify your joint center institutions and affiliates who are not on e-mail. Wendy Bergantz, RN/Deb Grant, RN RTOG Data Management DATE: April 6, 2009 SUBJECT: RTOG Investigator Brochure Update Notification of an updated Investigator Brochure has recently been received by RTOG for the following studies: RTOG 0619"A RANDOMIZED PHASE II TRIAL OF CHEMORADIOTHERAPY VERSUS CHEMORADIOTHERAPY AND VANDETANIB FOR HIGH-RISK POSTOPERATIVE ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK" The IB for the Vandetanib used in this study is available on the RTOG Website at http://www.rtog.org/investbrochure.html . The Summary of Changes (SOC) is included as part of the IB Investigator Brochures for other applicable RTOG Studies remain available from the following sources: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) The IB & Summary of Changes (SOC) for the Temozolomide used in this study is available on the RTOG Website at http://www.rtog.org/investbrochure.html . Please refer to the Protocol Notification broadcast sent 2/3/09 for applicable password information. RTOG 0417 "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG 0615 "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING THREE-DIMENSIONAL CONFORMAL RADIOTHERAPY (3D-CRT) or INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" The IB for the Bevacizumab used in these studies can be obtained from the NCI/PMB by contacting the IB Coordinator at ibcoordinator@mail.nih.gov or (301) 496-5725. RTOG 0524 "A PHASE I/II TRIAL OF A COMBINATION OF PACLITAXEL AND TRASTUZUMAB WITH DAILY IRRADIATION OR PACLITAXEL ALONE WITH DAILY IRRADIATION FOLLOWING TRANSURETHRAL SURGERY FOR NON-CYSTECTOMY CANDIDATES WITH MUSCLE-INVASIVE BLADDER CANCER" The IB for the Trastuzumab used in this study can be obtained from the NCI/PMB by contacting the IB Coordinator at ibcoordinator@mail.nih.gov or (301) 496-5725. RTOG 0627 "PHASE II TRIAL OF DASATINIB IN PATIENTS WITH RECURRENT GLIOBLASTOMA MULTIFORME" The IB for the Dasatinib used in this study can be obtained from the NCI/PMB by contacting the IB Coordinator at ibcoordinator@mail.nih.gov or (301) 496-5725. DATE: April 6, 2009 SUBJECT: RTOG 0623, Closure Closure RTOG 0623, "A Phase II Trial of Combined Modality Therapy with Growth Factor Support for Patients with Limited Stage Small Cell Lung Cancer", will close to patient accrual today, April 6th, at 5 p.m. EST, as the study has not met its accrual objective. (Notice of this closure was previously broadcast on 3/23/09.) Please notify your affiliates that are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, please e-mail rtogbroadcast@acr-arrs.org. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. DATE: April 2, 2009 SUBJECT: RTOG (0324), (0234), (0522), 0436, & 0617 PROTOCOL NOTICE: BMS, ImClone and/or NCI SAFETY REPORTS FOR CETUXIMAB RTOG has received safety report(s) from BMS, ImClone, and/or NCI for CETUXIMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by BMS, ImClone, and/or NCI. The Following RTOG studies involve CETUXIMAB: RTOG (0324) "A PHASE II STUDY OF CETUXIMAB (C225) IN COMBINATION WITH CHEMORADIATION IN PATIENTS WITH STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC)" RTOG (0234) "A PHASE II RANDOMIZED TRIAL OF SURGERY FOLLOWED BY CHEMORADIOTHERAPY PLUS C225 (CETUXIMAB) FOR ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK" RTOG (0522) "A PHASE III TRIAL OF CONCURRENT ACCELERATED RADIATION AND CISPLATIN VERSUS CONCURRENT ACCELERATED RADIATION, CISPLATIN, AND CETUXIMAB (C225) FOLLOWED BY SURGERY FOR RESIDUAL DISEASE FOR STAGE III AND IV HEAD AND NECK CARCINOMAS" RTOG 0436, "A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery" RTOG 0617/NCCTG N0628/CALGB 30609/ECOG R0617, "A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy with Concurrent and Consolidation Carboplatin/Paclitaxel +/-Cetuximab (IND#103444) in Patients with Stage IIIA/IIIB Non-Small Cell Lung Cancer"; Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - erbitux-ib13-esr324-fu01.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org ****Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments DATE: April 2, 2009 SUBJECT: RTOG 0617, Amended Amended RTOG 0617/NCCTG N0628/CALGB 30609/ECOG R0617, "A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy with Concurrent and Consolidation Carboplatin/Paclitaxel +/-Cetuximab (IND#103444) in Patients with Stage IIIA/IIIB Non-Small Cell Lung Cancer"; Amendment 3: The required FEV1 was amended. Sites can access the complete summary of changes at http://www.rtog.org/members/protocols/0617/summary_changes.html Sites can download a copy of the amended protocol for IRB review at http://www.rtog.org/members/protocols/0617/0617.pdf NCI policy requires that the "Version Date" on the protocol title page reflect the date the amendment was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses. Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. Please notify your affiliates that are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, please e-mail rtogbroadcast@acr-arrs.org. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. DATE: April 1, 2009 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0712 WEB-BASED ELECTRONIC DATA SUBMISSION UPDATE: RTOG 0712 A Phase II Randomized Study For Patients With Muscle-Invasive Bladder Cancer Evaluating Transurethral Surgery And Concomitant Chemoradiation By Either BID Irradiation Plus 5-Fluorouracil And Cisplatin Or QD Irradiation Plus Gemcitabine Followed By Selective Bladder Preservation And Gemcitabine/Cisplatin Adjuvant Chemotherapy Web-Based Electronic Data Submission is now available for the following form: RTOG 0712 F1 Per previous Broadcasts, web-based data submission became mandatory as of May 14, 2007 for all forms available for web-entry for all cases enrolled through RTOG. A complete listing of forms available for web data submission is available at http://www.rtog.org/members/webreg.html For technical support with web data submission, please email websupport@acr-arrs.org Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214. Elaine Motyka-Welsh, RN, MSN, CCRP Research Associate DATE: April 1, 2009 SUBJECT: RTOG eNews: Semiannual Meeting Registration and Attendee Information RTOG eNews April 1, 2009 RTOG Semiannual Meeting Registration & Attendee Information Radiation Therapy Oncology Group Semiannual Meeting Chicago Marriott Downtown Magnificent Mile June 25 - 28, 2009 Highlights include: Research Associates Orientation Program on Thursday, June 25th. RTOG 0825 Kick-Off Reception on Friday, June 26th: Phase III Double-Blind Placebo-Controlled Trial of Conventional Concurrent Chemoradiation and Adjuvant Temozolomide plus Bevacizumab Versus Conventional Concurrent Chemoradiation and Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma RTOG Symposium on Friday, June 26th: Globalization of RTOG Research Information about the meeting, including the agenda, the link for online registration, and the meeting brochure, is now available on the RTOG Web site (http://www.rtog.org/meeting/main.html). Please take advantage of the opportunity to complete your meeting registration in advance via the web. We also encourage you to book your hotel and travel accommodations early. Contact Us If you need further information or wish to be added to or removed from our mailing list please send an e-mail to Sharon Hartson Stine at: shartson@acr-arrs.org. RTOG's clinical trials are available at http://www.rtog.org/members/active.html. More information is available on the Web at www.rtog.org. DATE: March 31, 2009 SUBJECT: RTOG 0534, Amended and Updated Amended and Updated RTOG 0534, ""A Phase III Trial Of Short Term Androgen Deprivation With Pelvic Lymph Node Or Prostate Only Radiotherapy (SPPORT) In Prostate Cancer Patients With A Rising PSA After Radical Prostatectomy". Amendment #1: Revisions were made to protocol eligibility. Update: Participation in the neurocognitive testing is no longer mandatory for institutions. Institutions participating in the neurocognitive test battery must follow the certification process specified in the protocol. Sites can access the complete summary of changes for the amendment and the update at http://www.rtog.org/members/protocols/0534/summary_changes.html Sites can download a copy of the protocol for IRB review at http://www.rtog.org/members/protocols/0534/0534.pdf NCI policy requires that the "Version Date" on the protocol title page reflect the date the amendment was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses. Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. Expedited review is allowed; however, site IRB requirements take precedence. Please notify your affiliates who are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, please send an e-mail to rtogbroadcast@acr-arrs.org. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. DATE: March 31, 2009 SUBJECT: RTOG 0436, Amended: broadcast clarification Attention RTOG 0436 investigators: Please be advised that the statement "includes Amendment 1" was added to the cover page of the amended/updated protocol that was broadcast earlier today, due to its inadvertent omission during the broadcast process. The protocol is available via the link in the original broadcast email below. RTOG apologizes for any confusion. DATE: March 31, 2009 SUBJECT: RTOG (0324), (0234), 0522, 0436, & 0617 PROTOCOL NOTICE: IMPORTANT INSTRUCTIONS regarding ImClone/BMS CETUXIMAB Drug Recall IMPORTANT: A list of RTOG Institutions who received the affected/recalled Cetuximab/Erbitux Lot # 07Q00311B supplied for RTOG Clinical trials and have not responded is attached. Please review the list and provide the necessary accountability information as indicated in the attached withdrawal instructions before April 3, 2009. Please forward this information to the research pharmacist or other individual responsible for drug at your institution. - Erbitux recall RTOG sites 31Mar2009.pdf - Erbitux-07Q00311BWithdrawal-vBMSO-09Mar09.pdf DATE: March 31, 2009 SUBJECT: Form Revision Notice - RTOG 0537 Form Revision RTOG 0537 A Phase II/III Study Comparing Acupuncture-like Transcutaneous Electrical Nerve Stimulation (ALTENS) Versus Pilocarpine in Treating Early Radiation-Induced Xerostomia The following form for this study has been revised. Download the new version from the RTOG web site at http://www.rtog.org/pdf_forms.html?members/forms=0537/0537I1.pdf The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date I1 Initial Evaluation Form    I1a     03/31/09   Changes Made: Question #4: -Comorbidity conditions revised to be consistent with section 3.2.7. This form is currently available for web data submission Web-based data submission is mandatory for all forms that are available for web-entry for all cases enrolled through RTOG. A complete listing of all forms available for web-entry is available at: http://www.rtog.org/members/webreg.html For technical support with web data submission, please email websupport@acr-arrs.org. Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214. Please notify your joint center institutions and affiliates who are not on e-mail. Roseann Bonanni, CCRP RTOG Data Management 215-574-3223 Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: March 31, 2009 SUBJECT: RTOG 0436, Amended Amended and Updated RTOG 0436, "A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery" Amendment #1: Major changes include: (1) timing for pre-registration endoscopy with biopsy; and (2) clarifications concerning dose homogeneity. Update: Changes include: (1) timing of radiation administration on days patients receive chemotherapy; (2) notes concerning correlative study components. Please see the complete summary of changes for the amendment and update at http://www.rtog.org/members/protocols/0436/summary_changes.html Sites can download a copy of the amended protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/protocols/0436/0436.pdf NCI policy requires that the "Version Date" on the protocol title page reflect the date the amendment was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses. The "Update Date" indicates that administrative/editorial changes were made to the protocol. Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. If amendment involves changes to the risks section of the consent, RTOG recommends re-consenting patients on this trial; however, your local IRB will have the final authority. Please notify your affiliates that are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, please send an e-mail to rtogbroadcast@acr-arrs.org. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: March 30, 2009 SUBJECT: Web Data Submission Update - RTOG 0131 Web-based Electronic Data Submission Is Now Available For RTOG # 0131 F1 Follow-Up Form Per previous Broadcasts, web-based data submission became mandatory as of May 14, 2007 for all forms available for web-entry for all cases enrolled through RTOG. A complete listing of forms available for web data submission is available at http://www.rtog.org/members/webreg.html For technical support with web data submission, please email websupport@acr-arrs.org. Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214. Forms received in paper format after April 10, 2009 will be returned to the site for transcription. Please notify your joint center institutions and affiliates who are not on e-mail. Barbara Kaiser, RN, CCRP RTOG Data Management DATE: March 30, 2009 SUBJECT: RTOG (0411), 0417, 0615 & 0625 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety report(s) from NCI for BEVACIZUMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by the NCI. The Following RTOG studies involve BEVACIZUMAB: RTOG (0411) "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417 "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG 0615 "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - Bevacizumab, AE-1987521, Protocol E5103, ISR.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: March 30, 2009 SUBJECT: RTOG (0324), (0234), (0522), 0436, & 0617 PROTOCOL NOTICE: BMS, ImClone and/or NCI SAFETY REPORTS FOR CETUXIMAB RTOG has received safety report(s) from BMS, ImClone and/or NCI for CETUXIMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by BMS, ImClone, and/or NCI. The Following RTOG studies involve CETUXIMAB: RTOG (0324) "A PHASE II STUDY OF CETUXIMAB (C225) IN COMBINATION WITH CHEMORADIATION IN PATIENTS WITH STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC)" RTOG (0234) "A PHASE II RANDOMIZED TRIAL OF SURGERY FOLLOWED BY CHEMORADIOTHERAPY PLUS C225 (CETUXIMAB) FOR ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK" RTOG (0522) "A PHASE III TRIAL OF CONCURRENT ACCELERATED RADIATION AND CISPLATIN VERSUS CONCURRENT ACCELERATED RADIATION, CISPLATIN, AND CETUXIMAB (C225) FOLLOWED BY SURGERY FOR RESIDUAL DISEASE FOR STAGE III AND IV HEAD AND NECK CARCINOMAS" RTOG 0436, "A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery" RTOG 0617, "A RANDOMIZED PHASE III COMPARISON OF STANDARD- DOSE (60 Gy) VERSUS HIGHDOSE (74 Gy) CONFORMAL RADIOTHERAPY WITH CONCURRENT AND CONSOLIDATION CARBOPLATIN/PACLITAXEL IN PATIENTS WITH STAGE IIIA/IIIB NON-SMALL CELL LUNG CANCER" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - erbitux-ib13-323-fu01.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: March 27, 2009 SUBJECT: RTOG (0411), 0417, 0615 & 0625 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety report(s) from NCI for BEVACIZUMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by the NCI. The Following RTOG studies involve BEVACIZUMAB: RTOG (0411) "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417 "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG 0615 "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - Bevacizumab CCI-779, AE-1951869, Protocol 6986, -FU2.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: March 27, 2009 SUBJECT: RTOG (0324), (0234), (0522), 0436, & 0617 PROTOCOL NOTICE: BMS, ImClone and/or NCI SAFETY REPORTS FOR CETUXIMAB RTOG has received safety report(s) from BMS, ImClone and/or NCI for CETUXIMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by BMS, ImClone, and/or NCI. The Following RTOG studies involve CETUXIMAB: RTOG (0324) "A PHASE II STUDY OF CETUXIMAB (C225) IN COMBINATION WITH CHEMORADIATION IN PATIENTS WITH STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC)" RTOG (0234) "A PHASE II RANDOMIZED TRIAL OF SURGERY FOLLOWED BY CHEMORADIOTHERAPY PLUS C225 (CETUXIMAB) FOR ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK" RTOG (0522) "A PHASE III TRIAL OF CONCURRENT ACCELERATED RADIATION AND CISPLATIN VERSUS CONCURRENT ACCELERATED RADIATION, CISPLATIN, AND CETUXIMAB (C225) FOLLOWED BY SURGERY FOR RESIDUAL DISEASE FOR STAGE III AND IV HEAD AND NECK CARCINOMAS" RTOG 0436, "A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery" RTOG 0617, "A RANDOMIZED PHASE III COMPARISON OF STANDARD- DOSE (60 Gy) VERSUS HIGHDOSE (74 Gy) CONFORMAL RADIOTHERAPY WITH CONCURRENT AND CONSOLIDATION CARBOPLATIN/PACLITAXEL IN PATIENTS WITH STAGE IIIA/IIIB NON-SMALL CELL LUNG CANCER" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - erbitux-ib13-esr325.pdf - erbitux-ib13-esr326.pdf - erbitux-ib13-esr324.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: March 27, 2009 SUBJECT: Form Revision Notice & Web Data Submission Update - RTOG 0521 Web-based Electronic Data Submission RTOG 0521 A Phase III Protocol of Androgen Suppression (AS) and 3DCRT/IMRT vs AS and 3DCRT/IMRT Followed by Chemotherapy with Docetaxel and Prednisone for Localized, High-Risk Prostate Cancer Per previous Broadcasts, web-based data submission became mandatory as of May 14, 2007 for all forms available for web-entry for all cases enrolled through RTOG. A complete listing of forms available for web data submission is available at http://www.rtog.org/members/webreg.html For technical support with web data submission, please email websupport@acr-arrs.org. Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214. Forms Revision Notice The following form for this study has been revised. Download the new version from the RTOG web site at http://www.rtog.org/pdf_forms.html?members/forms=0521/0521tf.pdf. The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date TF    TFa     03/26/09   Changes: Question 13 - An option to report labs in both Conventional and SI units has been added Discard obsolete versions and commence use of the revised edition immediately. Obsolete versions received after April 10, 2009 will be returned to the site for transcription Please notify your joint center institutions and affiliates who are not on e-mail. Elaine Motyka-Welsh, RN, MSN, CCRP RTOG Data Management Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: March 26, 2009 SUBJECT: RTOG 0712, Updated Updated RTOG 0712, "A Phase II Randomized Study For Patients With Muscle-Invasive Bladder Cancer Evaluating Transurethral Surgery And Concomitant Chemoradiation By Either BID Irradiation Plus 5-Fluorouracil And Cisplatin Or QD Irradiation Plus Gemcitabine Followed By Selective Bladder Preservation And Gemcitabine/Cisplatin Adjuvant Chemotherapy" Update: Several sections of the protocol were updated for clarity. Sites can access the complete summary of changes at http://www.rtog.org/members/protocols/0712/summary_changes.html Sites can download a copy of the updated protocol by accessing the RTOG web site at http://www.rtog.org/members/protocols/0712/0712.pdf NCI policy requires that the "Version Date" on the protocol title page reflect the date the protocol was submitted by RTOG to NCI; the "Update Date" indicates that editorial/administrative changes were made to the protocol; for clarity, the broadcast date of the update is provided in parentheses. IRB review of an update is not required; however, these changes must be reported to site IRBs. Please notify your affiliates that are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, please send an e-mail to rtogbroadcast@acr-arrs.org. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: March 25, 2009 SUBJECT: RTOG eNews: RTOG Reports Long-Term Hormonal Therapy Improves Prostate Cancer Survival RTOG eNews March 25, 2009 RTOG Reports Long-Term Hormonal Therapy Improves Prostate Cancer Survival Men who continued on hormonal therapy for at least five years after their treatment for locally advanced prostate cancer lived longer than men who discontinued their therapy sooner, reports the Radiation Therapy Oncology Group (RTOG). RTOG investigators detail their findings in a paper published online ahead of print by the Journal of Clinical Oncology. RTOG is a National Cancer Institute-funded national clinical trials group and is administered by the American College of Radiology. RTOG investigators and other researchers have previously shown that adding androgen deprivation therapy (ADT) to pelvic radiotherapy improves survival for men with locally advanced prostate cancer, however the optimal duration of the hormonal therapy has not yet been established. In a secondary analysis of a large randomized trial (RTOG 8531) that compared radiotherapy alone versus radiotherapy plus adjuvant ADT until disease progression, the authors identified a cohort of 189 patients who discontinued their assigned ADT despite no evidence of disease recurrence. The analysis found that men who continued ADT for five or more years had five- and 11-year overall survival rates of 100 and 63.9 percent as compared to 66.7 and 33.1 percent for those with more than one year and less than five years of ADT and 71.9 and 41.7 percent for men with less than one year of ADT. The authors also reported improved disease-free survival and decreases in local failure and distant metastasis with ADT greater than five years. These results held even after adjusting for known prognostic variables such as age, prostate surgery, nodal status, stage, and central review of Gleason scores. "Although our analysis gives strong support to the hypothesis that long-term hormonal therapy leads to better outcome than the standard two to three year regimen, it is clear that a well-designed randomized trial is needed to definitively answer this question," said Louis Souhami, M.D., the lead author of the paper and a professor in the Department of Radiation Oncology at McGill University in Montreal, Quebec, Canada. This publication, (Souhami L, Bae K, Pilepich M, Sandler H: Impact of the Duration of Adjuvant Hormonal Therapy in Patients With Locally Advanced Prostate Cancer Treated With Radiotherapy: A Secondary Analysis of RTOG 85-31) is available on the Journal of Clinical Oncology Web site under Early Releases ( http://jco.ascopubs.org/cgi/content/abstract/JCO.2008.17.4052v1). Contact Us If you need further information or wish to be added to or removed from our mailing list please send an e-mail to shartson@acr-arrs.org. RTOG's clinical trials are available at http://www.rtog.org/members/active.html. More information is available on the Web at www.rtog.org. DATE: March 23, 2009 SUBJECT: RTOG 0623, Closure Notice Closure Notice RTOG 0623, "A Phase II Trial of Combined Modality Therapy with Growth Factor Support for Patients with Limited Stage Small Cell Lung Cancer", will close to patient accrual at end of business day, Monday, April 6th, as the study has not met its accrual objective. Please notify your affiliates that are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, please e-mail rtogbroadcast@acr-arrs.org. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. DATE: March 23, 2009 SUBJECT: RTOG (0324), (0234), (0522), 0436, & 0617 PROTOCOL NOTICE: BMS, ImClone and/or NCI SAFETY REPORTS FOR CETUXIMAB RTOG has received safety report(s) from BMS, ImClone and/or NCI for CETUXIMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by BMS, ImClone, and/or NCI. The Following RTOG studies involve CETUXIMAB: RTOG (0324) "A PHASE II STUDY OF CETUXIMAB (C225) IN COMBINATION WITH CHEMORADIATION IN PATIENTS WITH STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC)" RTOG (0234) "A PHASE II RANDOMIZED TRIAL OF SURGERY FOLLOWED BY CHEMORADIOTHERAPY PLUS C225 (CETUXIMAB) FOR ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK" RTOG (0522) "A PHASE III TRIAL OF CONCURRENT ACCELERATED RADIATION AND CISPLATIN VERSUS CONCURRENT ACCELERATED RADIATION, CISPLATIN, AND CETUXIMAB (C225) FOLLOWED BY SURGERY FOR RESIDUAL DISEASE FOR STAGE III AND IV HEAD AND NECK CARCINOMAS" RTOG 0436, "A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery" RTOG 0617, "A RANDOMIZED PHASE III COMPARISON OF STANDARD- DOSE (60 Gy) VERSUS HIGHDOSE (74 Gy) CONFORMAL RADIOTHERAPY WITH CONCURRENT AND CONSOLIDATION CARBOPLATIN/PACLITAXEL IN PATIENTS WITH STAGE IIIA/IIIB NON-SMALL CELL LUNG CANCER" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - erbitux-ib13-esr315-fu01.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: March 20, 2009 SUBJECT: RTOG 0614 - Guidelines for Submission of TF Form RTOG 0614 "A randomized, Phase III, double-blind, placebo-controlled trial of memantine for prevention of cognitive dysfunction in patients receiving whole-brain radiotherapy" Guidelines for submission of the TF form for RTOG 0614 are now available on the RTOG website at the following address: http://www.rtog.org/pdf_forms.html?members/forms=0614/TF_Guidelines.doc If you need further assistance, please contact RTOG Data Management at 215-574-3214. Please notify your affiliates who are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, please e-mail rtogbroadcast@acr-arrs.org . DATE: March 20, 2009 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 9903 Web-based Electronic Data Submission Is Now Available For RTOG # 9903 F1 Follow-Up Form Per previous Broadcasts, web-based data submission became mandatory as of May 14, 2007 for all forms available for web-entry for all cases enrolled through RTOG. A complete listing of forms available for web data submission is available at http://www.rtog.org/members/webreg.html For technical support with web data submission, please email websupport@acr-arrs.org. Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214. Forms received in paper format after April 3, 2009 will be returned to the site for transcription. Please notify your joint center institutions and affiliates who are not on e-mail. Joli Lavarino, B.A., C.C.R.P. RTOG Data Management DATE: March 19, 2009 SUBJECT: RTOG 0619, Incorrect IND number for vandetanib IMPORTANT: The IND number for vandetanib on the title page of RTOG 0619, "A Randomized Phase II Trial of Chemoradiotherapy Versus Chemoradiotherapy and Vandetanib for High-Risk Postoperative Advanced Squamous Cell Carcinoma of the Head And Neck", is incorrect. RTOG's cross filed IND number for vandetanib is 103,648. We apologize for this error, and it will be corrected in a future amendment of the protocol. Please notify your affiliates that are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, please e-mail rtogbroadcast@acr-arrs.org. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. DATE: March 18, 2009 SUBJECT: SWOG Coordinated Study Terminations RTOG Study Terminations The intergroup studies listed below have been completed and terminated by the coordinating group, SWOG (Southwest Oncology Group). Effective March 18, 2009 all study activity and data collection will cease and institutions should notify their local IRBs/REBs of the terminations. Any data received after March 18, 2009 will be returned to the submitting institution. GYN: RTOG 9112/SWOG 8797: A Randomized Comparison of 5-FU Infusion and Bolus Cisplatin as an Adjunct to Radiation Therapy versus Radiation Therapy alone in Selected Patients with Stages I-A2, I-B and II-A Carcinoma of the Cervix Following Radical Hysterectomy and Node Dissection GastroIntestinal: RTOG 9018/SWOG 9008: Phase III Trial of Adjuvant Chemoradiation after Gastric Resection for Adenocarcinoma RTOG 9403/SWOG 9304: Postoperative Evaluation of 5-FU by Bolus Injection vs. 5-FU by Prolonged Venous Infusion Prior to and Following Combined Prolonged Venous Infusion Plus Pelvic Xrt vs. Bolus 5-FU Plus Leucovorin Plus Levamisole Prior to and Following Combined Pelvic Xrt Plus Bolus 5-Fu Plus Leucovorin In Patients With Rectal Cancer, Phase III Please notify your affiliates that are not on this e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, please send an e-mail to rtogbroadcast@acr-arrs.org. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. DATE: March 17, 2009 SUBJECT: RTOG 0320 PROTOCOL NOTICE: NCI SAFETY REPORT for ERLOTINIB RTOG has received safety report(s) from the NCI/NIH for Erlotinib the Following RTOG study(s) involve Erlotinib: RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR ERLOTINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - OSI-774, AE-1225018, Protocol CALGB-30406, -ISR.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. DATE: March 17, 2009 SUBJECT: RTOG (0411), 0417, 0615 & 0625 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety report(s) from NCI for BEVACIZUMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by the NCI. The Following RTOG studies involve BEVACIZUMAB: RTOG (0411) "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417 "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG 0615 "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - Bevacizumab AE-1433885 Protocol E5103 -FU1.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: March 17, 2009 SUBJECT: RTOG eNews: RTOG Awarded $60.5 Million for Six-Year Grant Renewal RTOG eNews March 17, 2009 RTOG Awarded $60.5 Million for Six-Year Grant Renewal The National Cancer Institute extended its cooperative group agreement with the Radiation Therapy Oncology Group for an additional six years and awarded the group $60.5 million to carry out its research effort. RTOG has received 36 years of continuous funding from the NCI and this award will sustain the group's efforts until 2014. RTOG is the leading national multicenter clinical trials organization dedicated to testing novel radiotherapy and combined modality approaches in pursuit of improving the survival and quality of life of patients with cancer. RTOG is administered by the American College of Radiology. The independent panel convened by the NCI to review the accomplishments and future research plans of the group found that "RTOG is the premier radiation therapy organization among the Cooperative Groups and the clear international leader in this arena. In addition, RTOG has had a major impact on the technical quality of radiation delivery at all levels of the health care enterprise, since procedures adopted by RTOG are widely accepted beyond protocol studies." The review panel rated RTOG's research accomplishments and future plans for patients with brain tumors, head and neck cancer, and genitourinary cancer as outstanding. RTOG's other major scientific research areas were rated as excellent: gastrointestinal cancer, lung cancer, advanced technology integration, health services and outcomes research, and translational research. The panel highlighted several of the group's accomplishments including: a reduction in local recurrence with the use of chemoradiotherapy for patients with advanced head and neck cancer; an increase in survival for patients with advanced pancreatic adenocarcinoma; a 33% improvement in survival for patients with a single brain metastasis; a clarification of the benefit of adding cisplatin to 5-FU, mitomycin C, and radiotherapy for anal canal cancer; a definition of the role of surgery in N2 lung cancer; and the establishment of a standard of care for bone metastases at a single high dose of radiation therapy. "The strength and breadth of RTOG's recent investigations and its innovative plans for future research is a testimony to the dedication, creativity, and intellectual rigor of our member investigators," said Walter J. Curran, Jr., the RTOG Group Chair and principal investigator of this award. "For over 40 years RTOG has set the standard for radiation therapy-related research both in the United States and internationally. NCI's award of the maximum term of funding is a validation of our research," stated Curran, who is the Lawrence W. Davis Professor and Chair of the Department of Radiation Oncology in the Emory School of Medicine and Chief Medical Officer of the Emory Winship Cancer Institute. The NCI cooperative clinical research grant will help fund RTOG's roster of 37 clinical trials open to patient enrollment at over 300 major research institutions in the United States, Canada, and internationally. The award supports the group's headquarters and statistical center in Philadelphia and helps to defray the cost of patient enrollment at RTOG's member sites. Contact Us If you need further information or wish to be added to or removed from our mailing list please send an e-mail to shartson@acr-arrs.org. RTOG's clinical trials are available at http://www.rtog.org/members/active.html. More information is available on the Web at www.rtog.org. DATE: March 12, 2009 SUBJECT: RTOG 0618, Amended Amended RTOG 0618, "A Phase II Trial of Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Patients with Operable Stage I/II Non-Small Cell Lung Cancer"; Amendment 2: The baseline FEV1 has been amended, dose painting delivery techniques including IMRT are now allowed, and sublobar or wedge resections are permitted. Sites can access the complete summary of changes for the amendment at http://www.rtog.org/members/protocols/0618/summary_changes.html Sites can download a copy of the protocol for IRB review at http://www.rtog.org/members/protocols/0618/0618.pdf NCI policy requires that the "Version Date" on the protocol title page reflect the date the amendment was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses. Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. Expedited review is allowed; however, site IRB requirements take precedence. Please notify your affiliates who are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Sites should not contact Michelle Buado for any other reason or reply directly to this broadcast. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. DATE: March 12, 2009 SUBJECT: RTOG 0320 PROTOCOL NOTICE: NCI SAFETY REPORT for ERLOTINIB RTOG has received safety report(s) from the NCI/NIH for Erlotinib the Following RTOG study(s) involve Erlotinib: RTOG 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR ERLOTINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - CCI-779 OSI-774, AE-1192065, Protocol NABTC-04-02, -ISR.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. DATE: March 12, 2009 SUBJECT: RTOG 0438, Closed Effective Immediately Closed to Accrual RTOG 0438, "A Phase I Trial of Highly Conformal Radiation Therapy for Patients With Liver Metastases," is closed effective immediately for the protocol-specified toxicity evaluation of dose level IV (5.0 Gy/fx for a total of 50 Gy). We apologize for any inconvenience with respect to patients currently being worked up for this trial, but as safety is the primary endpoint, this closure must take place immediately. Please notify your affiliates who are not on e-mail. To share a comment or ask a question, access the Headquarters Information and Telephone Listing on the RTOG web site, www.rtog.org, under "Member Info", or call 1-800-227-5463, ext. 4189, which provides a menu to reach the Headquarters departments. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. DATE: March 12, 2009 SUBJECT: RTOG eNews: RTOG Participating in Annual Oral, Head and Neck Cancer Awareness Week RTOG eNews March 12, 2009 RTOG Participating in Annual Oral, Head and Neck Cancer Awareness Week With oral, head and neck cancer claiming more than 8,000 lives each year, screening and early diagnosis are critical to optimizing treatment and increasing survival. This year RTOG is working with the Head and Neck Cancer Alliance (HNCA, formerly known as the Yul Brynner Head and Neck Cancer Foundation) to raise awareness of the disease and stress early detection with its 12th Annual Oral, Head and Neck Cancer Awareness Week (OHANCAW), April 27-May 3, 2009. The week is highlighted by a worldwide day of free oral cancer screenings at medical and dental offices, centers and institutions across the country and overseas. Some locations organize an oral cancer walkathon, provide research presentations or conduct survivor events. We are encouraging our members to participate in this important effort by organizing a local program that can include offering free oral cancer screenings on the day of your choice during OHANCAW 2009. Participants in OHANCAW make a vital contribution to increasing public awareness of oral, head and neck cancer, its symptoms and risk factors, and the importance of early diagnosis for successful management and survival of this potentially deadly but entirely treatable disease. Your participation will provide an excellent opportunity to highlight your group's commitment to the community and dedication to cancer prevention and early detection. Most sites offering free screenings have been able to secure free newspaper, TV or radio coverage since they are offering a free health event for citizens of their community. Participants in OHANCAW 2009 will be provided with information by the HNCA for guidance on planning your event and support materials, including a customizable press release and publicity guide to help promote activities with your local media, as well as poster samples, flyers and t-shirts. You can contact the HNCA directly at 843-792-6624 or info@ohancaw.com with questions about how best to organize your local event. Sites interested in taking part can sign up online. Go to the official website where all participating sites will be listed, www.OHANCAW.com and click on "Sign Up for 2009." In addition to local outreach efforts, each year the HNCA conducts a national public relations campaign to promote the screenings. In the past, the organization has partnered with baseball great Brett Butler and college football coaching legend Lou Holtz, both of whom helped raise awareness of the disease and OHANCAW. In 2009, for the second year in a row, Lori Hamilton, wife of NASCAR racing legend Bobby Hamilton who died of oral cancer in 2007, will be the national spokesperson for this initiative Please let us know if your institution plans to participate in OHANCAW by sending an e-mail to Sharon Hartson at RTOG Headquarters (shartson@acr-arrs.org). Contact Us If you need further information or wish to be added to or removed from our mailing list please send an e-mail to shartson@acr-arrs.org. RTOG's clinical trials are available at http://www.rtog.org/members/active.html. More information is available on the Web at www.rtog.org. DATE: March 11, 2009 SUBJECT: RTOG (0324), (0234), 0522, 0436, & 0617 PROTOCOL NOTICE: IMPORTANT INSTRUCTIONS regarding ImClone/BMS CETUXIMAB Drug Recall IMPORTANT INSTRUCTIONS regarding the BMS/ImClone Withdrawal of Cetuximab/Erbitux Lot # 07Q00311B supplied for RTOG Clinical trials In addition the information broadcast 3/10/09 BMS has provided detailed instructions for addressing the Cetuximab/Erbitux withdrawal of Lot # 07Q00311B supplied for RTOG Clinical trials. Please read the attached letter carefully and follow the instructions provided. Response from sites who have received the affected lot number is required within 48 hours. - Erbitux-07Q00311BWithdrawal-vBMSO-09Mar09.pdf DATE: March 10, 2009 SUBJECT: RTOG (0324), (0234), 0522, 0436, & 0617 PROTOCOL NOTICE: ADDITIONAL INFORMATION regarding ImClone/BMS CETUXIMAB Drug Recall IMPORTANT ADDITIONAL INFORMATION regarding ImClone/BMS CETUXIMAB Drug Recall Please Note: It will be necessary to check all remaining inventory for the studies identified above for the affected Lot # 07Q00311B There were two separate distributors of Cetuximab for RTOG Studies: BMS is responsible for Cetuximab distribution for RTOG Studies 0234. 0324 & 0522 BIOLOGICS is responsible for Cetuximab distribution for RTOG Studies 0436 & 0617 Please be sure to contact the appropriate distributor for replacement of the recalled Cetuximab BMS can be reached at: 866-339-4267 or cetuximab.supply@bms.com Biologics can be reached at: 800-850-4306 or clinicaltrials@biologicstoday.com The studies listed in the earlier broadcast today as having received the affected lots only included the Biologics distributed drug (for Studies 0436 & 0617). BMS has not provided a site specific list of recipients of the affected lots (for Studies 0234, 0324 or 0522). We apologize for the confusion. ImClone Systems Corporation (manufacturer) has initiated a voluntary recall of a number of lots of the ERBITUX® (cetuximab) 100mg/50mL single -use vials, in conjunction with Bristol-Myers Squibb Company (distributor). ImClone is initiating this recall as a precautionary measure due to the potential presence of a small number of cracked vials. There is a risk that these cracked vials may lead to a loss of sterility. Our records indicate that RTOG sites may have received one of the affected lots (07Q00311B) from BMS in conjunction with a clinical study. Please cease use of the subject lot immediately. If insufficient replacement clinical inventory (i.e., other than the subject lot) is available for upcoming patient visits (e.g., over the next week), please initiate a re-supply request through your normal drug supply processes at your earliest opportunity. Thank you for your cooperation and assistance, and we regret any inconvenience this matter may cause. DATE: March 10, 2009 SUBJECT: RTOG (0411), 0417, 0615 & 0625 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety report(s) from NCI for BEVACIZUMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by the NCI. The Following RTOG studies involve BEVACIZUMAB: RTOG (0411) "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417 "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG 0615 "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - BevacizumabAE-1324148 Protocol E5103 -FU1.pdf - Bevacizumab CCI-779, AE-1360351, Protocol 7190, -ISR.pdf - Bevacizumab Oxaliplatin, AE-1201753, Protocol E5204, -ISR.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: March 10, 2009 SUBJECT: RTOG (0324), (0234), (0522), 0436, & 0617 PROTOCOL NOTICE: BMS, ImClone and/or NCI SAFETY REPORTS FOR CETUXIMAB RTOG has received safety report(s) from BMS, ImClone and/or NCI for CETUXIMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by BMS, ImClone, and/or NCI. The Following RTOG studies involve CETUXIMAB: RTOG (0324) "A PHASE II STUDY OF CETUXIMAB (C225) IN COMBINATION WITH CHEMORADIATION IN PATIENTS WITH STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC)" RTOG (0234) "A PHASE II RANDOMIZED TRIAL OF SURGERY FOLLOWED BY CHEMORADIOTHERAPY PLUS C225 (CETUXIMAB) FOR ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK" RTOG (0522) "A PHASE III TRIAL OF CONCURRENT ACCELERATED RADIATION AND CISPLATIN VERSUS CONCURRENT ACCELERATED RADIATION, CISPLATIN, AND CETUXIMAB (C225) FOLLOWED BY SURGERY FOR RESIDUAL DISEASE FOR STAGE III AND IV HEAD AND NECK CARCINOMAS" RTOG 0436, "A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery" RTOG 0617, "A RANDOMIZED PHASE III COMPARISON OF STANDARD- DOSE (60 Gy) VERSUS HIGHDOSE (74 Gy) CONFORMAL RADIOTHERAPY WITH CONCURRENT AND CONSOLIDATION CARBOPLATIN/PACLITAXEL IN PATIENTS WITH STAGE IIIA/IIIB NON-SMALL CELL LUNG CANCER" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - erbitux-ib13-esr323.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: March 10, 2009 SUBJECT: RTOG (0324), (0234), 0522, 0436, & 0617 PROTOCOL NOTICE: ImClone/BMS CETUXIMAB Drug Recall ImClone Systems Corporation (manufacturer) has initiated a voluntary recall of a number of lots of the ERBITUX® (cetuximab) 100mg/50mL single -use vials, in conjunction with Bristol-Myers Squibb Company (distributor). ImClone is initiating this recall as a precautionary measure due to the potential presence of a small number of cracked vials. There is a risk that these cracked vials may lead to a loss of sterility. Our records indicate that RTOG sites may have received one of the affected lots (07Q00311B) from BMS in conjunction with a clinical study. The Following RTOG Institutions have received drug supply from the affected lot: 3425 - Cancer Centers of the Carolinas 7830 - Kaiser Permanente 3442 - Iowa Oncology Research 2508 - Intermountain Medical Center 3340 - C.R. wood Cancer Center at Glens Falls Hospital Please cease use of the subject lot immediately. If insufficient replacement clinical inventory (i.e., other than the subject lot) is available for upcoming patient visits (e.g., over the next week), please initiate a re-supply request through your normal drug supply processes at your earliest opportunity. Thank you for your cooperation and assistance, and we regret any inconvenience this matter may cause. DATE: March 9, 2009 SUBJECT: IMPORTANT INFORMATION REGARDING ALL RTOG PROTOCOLS IMPORTANT INFORMATION REGARDING ALL RTOG PROTOCOLS: Institutional participation in an RTOG study requires that the site be prepared to participate in all components of the study. The site must offer the patient the opportunity to participate in all components. Only the patient can choose to opt out of the correlative components of the study by declining during the consent process. An Institutional IRB cannot elect to remove any portion of the consent related to correlative components. Institutions should carefully review new clinical trials for all correlative components prior to making the decision to open the study at their sites. PLEASE NOTE: If a site has removed the correlative components portion of the consent at an IRB's request using the IRB Justification of Consent Changes Process the change is considered null and void and a major deficiency will be given during the site audit. Please also be advised, there is no acceptable justification for the removal of the correlative components of the study. Sites unable to comply with all study requirements should refrain from opening the study. DATE: March 6, 2009 SUBJECT: Form Revision Notice - RTOG 0614 RTOG 0614 Form Revision Phase III Memantine/Brain Mets The following form for this study has been revised. Download the new version from the RTOG web site at http://www.rtog.org/pdf_forms.html?members/forms=0614/0614i1.pdf The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date I1 Initial Evaluation Form    I1a     3-6-09   Changes Made: Question #11: Additional element added in code table #5 - total resection. Web-based data submission is mandatory for all forms available for web-entry for all cases enrolled through RTOG. A complete listing of all forms available for web data submission is available at http://www.rtog.org/members/webreg.html For technical support with web data submission, please e-mail websupport@acr-arrs.org Questions regarding information being collected on the forms should be directed to RTOG Data Management at 25-574-3214. Please notify your joint center institutions and affiliates who are not on e-mail. Sandrine Geinoz, PhD, CCRP RTOG Data Management Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: March 5, 2009 SUBJECT: Form Revision Notice - RTOG 9903 RTOG 9903 Phase III Head & Neck Form Revision The following form for this study has been revised. Download the new version from the RTOG web site at http://www.rtog.org/pdf_forms.html?members/forms=9903/9903f1.pdf The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date F1 Follow-up Form    F1b     3-5-09   Changes Made: Page 3, column 5 has been corrected to read “Date of 1st Occurrence of Grade > 3”. Please discard obsolete versions and commence use of the revised edition immediately. Please notify your joint center institutions and affiliates who are not on e-mail. Joli Lavarino, B.A., C.C.R.P. RTOG Research Associate Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: March 5, 2009 SUBJECT: RTOG eNews: Thank you to RTOG 0522 Participating Institutions! Thank You to RTOG 0522 Accruing Sites Thank you to the institutions that helped RTOG 0522, A Randomized Phase III Trial of Concurrent Accelerated Radiation and Cisplatin versus Concurrent Accelerated Radiation, Cisplatin, and Cetuximab (C225) [Followed by Surgery for Selected Patients] for Stage III and IV Head and Neck Carcinomas, meet its accrual goal. A total of 942 patients were entered from 151 sites. According to Kian Ang, MD, the study's principal investigator, "We congratulate the RTOG investigators and clinical research associates on their commitment to enter patients onto this important trial. The accrual rate far exceeded the projection based on our prior track record. Because of the strong support of our members we were able to increase the sample size and use a surrogate endpoint of progression-free survival. This change will allow us to analyze our primary endpoint after three years of follow-up instead of four and report our results sooner." Accruing Sites to RTOG 0522 Inst Name Accrual H. Lee Moffitt Cancer Center & Research Institute 40 University of Louisville 36 McGill University 30 Roswell Park Cancer Institute 30 University of Alabama at Birmingham Medical Center 26 University of Texas-MD Anderson Cancer Center 24 Radiological Associates of Sacramento 21 University of Oklahoma Health Sciences Center 20 University of Colorado Denver 20 Stanford University Medical Center 19 John H. Stroger, Jr., Hospital of Cook County MBCCOP 19 Emory University 18 Fox Chase Cancer Center 18 University of Utah Health Science Center 17 The Ottawa Hospital Regional Cancer Centre 17 Virginia Mason CCOP 16 MD Anderson Cancer Center - Orlando 16 University of Cincinnati 15 Tom Baker Cancer Centre 14 Christiana Care Health Services, Inc. 14 University of Wisconsin Hospital 13 Medical College of Virginia Hospitals 13 University of California Davis Medical Center 13 Notre Dame Hospital/University of Montreal 12 University of Texas Southwestern Medical School 12 City of Hope Medical Center 12 Geisinger Medical Center 11 Pocono Cancer Center 11 East Carolina Medical School 11 University of Rochester 10 Princess Margaret Hospital 10 University of Texas at San Antonio 10 Thomas Jefferson University Hospital 9 Akron City Hospital 9 Dixie Medical Cancer Center 9 Medical College of Wisconsin 9 Methodist Cancer Center 9 Zablocki VA Medical Center-Wood 9 Mt. Sinai Comprehensive Cancer Center CCOP 8 Oregon Health & Science University 8 Greenville S.C. CCOP 8 Wake Forest University Baptist Medical Center 8 West Michigan Cancer Center CCOP 7 University of Kentucky Hospital 7 St Johns Hospital, Cancer Institute 7 Sentara Norfolk General Hospital 7 St. Joseph Mercy Hospital 7 Northeastern Ontario Regional Cancer Centre 7 Mayo Clinic 6 Cancer Care Manitoba Foundation 6 University of California San Francisco 6 Kansas City CCOP 5 University of Miami 5 The Schiffler Cancer Center 5 St. Agnes Healthcare 5 Clarian Health Partners, Inc. 5 Atlanta VA Medical Center 5 Nevada Cancer Research Foundation 4 Reading Hospital and Medical Center 4 Naval Medical Center/Portsmouth 4 Riverview Medical Center/Riverview Reg. Cancer Center 4 Piedmont Hospital 4 Lahey Clinic Medical Center 4 North Shore Cancer Center 4 University of Texas Medical Branch 4 Good Samaritan Hospital 4 Nova Scotia Cancer Centre 4 Raleigh Hematology Oncology Associates 4 Grady Memorial Hospital 4 Dartmouth Hitchcock Medical Center 4 Mercy San Juan Radiation Oncology Center 4 ICON- Cancer Center of Putnam 4 Moffitt South Cancer Center 4 Univ of Kansas Comprehensive Cancer Center 3 Lutheran General Hospital 3 Cancer Institute of Cape Girardeau 3 Community Medical Center 3 Carle Cancer Center CCOP 3 Central Illinois CCOP Decatur, IL 3 Univ. of Kansas Cancer Center 3 Swedish Medical Center 3 Medical University of South Carolina 3 Gunderson Clinic 3 St. Vincent Regional Cancer Center CCOP 3 Mayo Clinic Scottsdale 3 ICON- Baptist Medical Center South 3 Roseville Radiation Oncology Center 3 Brooke Army Medical Center 2 Rapid City Regional Hospital 2 UCSD - University of California, San Diego 2 UMDNJ-New Jersey Medical School 2 York Cancer Center 2 Methodist Medical Center of Illinois 2 St. Louis University Hospitals 2 Northern Indiana Cancer Research Consortium 2 Florida Radiation Oncology Group / Baptist Regional 2 New Mexico Oncology Hematology Consultants 2 John Muir Medical Center - Concord Campus 2 Intermountain Medical Center 2 Memorial Medical Center 2 Tufts Medical Center Hospital 2 Albert Einstein Medical Center 2 Ocean Medical Center 2 Mary Bird Perkins Cancer Center 2 David Grant USAF Medical Center 2 Rush University Medical Center 2 Henry Ford Hospital 2 Cox Health System 2 Memorial Medical Center 2 St. Luke's Mountain States Tumor Institute 2 Alta Bates Hospital Comprehensive Cancer Center 2 W.A. Foote Memorial Hospital 2 Wausau Hospital Center 2 Advocate Good Samaritan Hospital 2 ICON- Orange Park Cancer Center 2 The Wendt Regional Cancer Center of the Finley Hospital 1 Saint John's Health System Cancer Center 1 St. Lukes Hospital Association of Duluth 1 Mercy Catholic Medical Center/Fitzgerald 1 Bay Medical Center 1 Washington University 1 Akron General Medical Center 1 Wilford Hall USAF Medical Center 1 Dubs Cancer Center @ Rogue Valley Medical Center 1 Joe Arrington Cancer Research & Treatment Center 1 LDS Hospital 1 Penrose Cancer Center, 1 Utah Valley Regional Medical Center 1 Rodger Maris Cancer Center 1 Alegent Health Bergan Mercy 1 St. Joseph/Chandler Health System 1 St Francis Hospital 1 Sanford Cancer Center 1 Washington Cancer Institute 1 Thedacare Cancer Institute 1 St James Hospital and Health Centers 1 Allan Blair Cancer Centre 1 Presbyterian Hospital 1 Genesys Regional Medical Center 1 Providence Hospital 1 Beaumont CCOP 1 Memorial Mission-St. Joseph's 1 Saint Francis Medical Center 1 JC Robinson, MD Regional Cancer Center 1 Emory Crawford Long Hospital 1 St. Vincent Hospital and Health Care Centers, Inc. 1 Elliot Hospital 1 Hunter Holmes McGuire Veterans Hospital 1 Utah Cancer Specialists 1 The Regional Cancer Ctr. at Singing River Hospital System 1 ICON- Flagler Cancer Center 1 TOTAL 942 Contact Us If you need further information about articles in the RTOG Newsletter please send an e-mail to shartson@acr-arrs.org. RTOG's clinical trials are available at http://www.rtog.org/members/active.html. More information is available on the Web at http://www.rtog.org DATE: March 3, 2009 SUBJECT: RTOG 0522, Closed to Accrual Effective Immediately Closure RTOG 0522, "A Randomized Phase III Trial of Concurrent Accelerated Radiation and Cisplatin Versus Concurrent Accelerated Radiation, Cisplatin, and Cetuximab (C225) [Followed by Surgery for Selected Patients] for Stage III and IV Head and Neck Carcinomas", is closed to patient accrual effective immediately as it has met its accrual objective. (Closure notices were previously broadcast on 2/4/09 and 2/20/09). Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at http://www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. DATE: February 26, 2009 SUBJECT: RTOG (0324), (0234), 0522, 0436, & 0617 PROTOCOL NOTICE: BMS, ImClone and/or NCI SAFETY REPORTS FOR CETUXIMAB RTOG has received safety report(s) from BMS, ImClone and/or NCI for CETUXIMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by BMS, ImClone, and/or NCI. The Following RTOG studies involve CETUXIMAB: RTOG (0324) "A PHASE II STUDY OF CETUXIMAB (C225) IN COMBINATION WITH CHEMORADIATION IN PATIENTS WITH STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC)" RTOG (0234) "A PHASE II RANDOMIZED TRIAL OF SURGERY FOLLOWED BY CHEMORADIOTHERAPY PLUS C225 (CETUXIMAB) FOR ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK" RTOG 0522 "A PHASE III TRIAL OF CONCURRENT ACCELERATED RADIATION AND CISPLATIN VERSUS CONCURRENT ACCELERATED RADIATION, CISPLATIN, AND CETUXIMAB (C225) FOLLOWED BY SURGERY FOR RESIDUAL DISEASE FOR STAGE III AND IV HEAD AND NECK CARCINOMAS" RTOG 0436, "A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery" RTOG 0617, "A RANDOMIZED PHASE III COMPARISON OF STANDARD- DOSE (60 Gy) VERSUS HIGHDOSE (74 Gy) CONFORMAL RADIOTHERAPY WITH CONCURRENT AND CONSOLIDATION CARBOPLATIN/PACLITAXEL IN PATIENTS WITH STAGE IIIA/IIIB NON-SMALL CELL LUNG CANCER" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. erbitux-ib13-esr320-fu01.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at http://www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. DATE: February 26, 2009 SUBJECT: RTOG (0411), 0417, 0615 & 0625 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety report(s) from NCI for BEVACIZUMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by the NCI. The Following RTOG studies involve BEVACIZUMAB: RTOG (0411) "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417 "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG 0615 "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. BAY 43-9006 BevacizumabAE-1475911 Protocol E2804-FU1.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org http://www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. DATE: February 25, 2009 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0618 Web-based Electronic Data Submission Is Now Available For RTOG # 0618 F1 Follow-Up Form Per previous Broadcasts, web-based data submission became mandatory as of May 14, 2007 for all forms available for web-entry for all cases enrolled through RTOG. A complete listing of forms available for web data submission is available at http://www.rtog.org/members/webreg.html For technical support with web data submission, please email websupport@acr-arrs.org. Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214. Forms received in paper format after March 13, 2009 will be returned to the site for transcription. Please notify your joint center institutions and affiliates who are not on e-mail. Mary Gramkowski, RN, BA, CCRP RTOG Data Management DATE: February 25, 2009 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0813 Web-based Electronic Data Submission Is Now Available For RTOG # 0813 I1 Initial Evaluation Form Per previous Broadcasts, web-based data submission became mandatory as of May 14, 2007 for all forms available for web-entry for all cases enrolled through RTOG. A complete listing of forms available for web data submission is available at http://www.rtog.org/members/webreg.html For technical support with web data submission, please email websupport@acr-arrs.org. Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214. Please notify your joint center institutions and affiliates who are not on e-mail. Mary Gramkowski, RN, BA, CCRP RTOG Data Management DATE: February 24, 2009 SUBJECT: CHANGE TO PROSTATE CORE PROCESSING BY PUNCH KITS RTOG STUDIES 0232, 0415, 0521, 0526, 0621 Attention: Change to Prostate Core Processing by Punch Kits RTOG STUDIES 0232, 0415, 0521, 0526, 0621 The RTOG Biospecimen Resource is in the process of updating Section 10 for the prostate study protocols 0232, 0415, 0521, 0526, and 0621 to reflect a change in specimen collection for tissue banking. We will no longer provide punch kits for these studies. Although the protocols posted on the RTOG website (http://www.rtog.org) will not immediately reflect this change, institutions participating in the above protocols should implement these procedures immediately. This change is being implemented because there is a very low success rate of obtaining adequate tumor tissue from prostate needle core tissue blocks when using the RTOG standard 2mm skin punch protocol. Therefore, for protocols involving prostate needle core biopsies, an H&E slide with tumor present must be submitted to the Biospecimen Resource as follows: 1) Send the corresponding FFPE block to be banked by the Biospecimen Resource (preferred). OR 2) If the institution will release the block but requires that it be returned, we will make the unstained slides (or take a punch from it if possible) before returning it. OR 3) If the institution will not release the block, then send at least 10 (but no more than 20) unstained sections cut at 5 micron thickness and placed on positively charged slides. If the study allows tumor-containing transurethral resection of the prostate (TURP) material for patient enrollment (RTOG 0415 and 0521) institutions must submit the specimen as follows: If the institution will not release the block, then: a) If the material is prostate needle core biopsy, send at least 10 (but no more than 20) unstained sections cut at 5 micron thickness and placed on positively charged slides. b) If the material is from a TURP specimen, send a 2mm core punched from the tumor area of the block using a dermpunch or similar device (kits for punching blocks can be obtained from the Biospecimen Resource), or send at least 10 (but no more than 20) unstained sections cut at 5 micron thickness and placed on positively charged slides. If you have any questions regarding this change of procedure please contact the RTOG Biospecimen Resource Manager at RTOG.manager@ucsf.edu. Thank you for your cooperation with this matter. Dr. Frederic Waldman and Dr. Jeffry Simko Director and Co-Director, RTOG Biospecimen Resource DATE: February 24, 2009 SUBJECT: RTOG 0524, Updated Updated RTOG 0524, “A Phase I/II Trial Of A Combination Of Paclitaxel And Trastuzumab With Daily Irradiation Or Paclitaxel Alone With Daily Irradiation Following Transurethral Surgery For Non-Cystectomy Candidates With Muscle-Invasive Bladder Cancer”: Sections 4.1, 5.1, 8.1, and 10.0 have been updated. Sites can access the complete summary of changes at http://www.rtog.org/members/protocols/0524/summary_changes.html Sites can download a copy of the updated protocol by accessing the RTOG web site at http://www.rtog.org/members/protocols/0524/0524.pdf The "Update Date" on the protocol title page indicates that editorial/administrative changes were made to the protocol; for clarity, the broadcast date of the update is provided in parentheses at the top of the summary of changes for the update. IRB review of an update is not required; however, these changes must be reported to site IRBs. Please notify your affiliates that are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Sites should not contact Michelle Buado for any other reason or reply directly to this broadcast. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. DATE: February 24, 2009 SUBJECT: RTOG 0627, Notification of Action Letter and Amendment Forthcoming RTOG has received an ACTION LETTER from NCI/NIH for dasatinib (BMS-354825, NSC 732517, IND 73969). The Action Letter pertains to RTOG 0627, ”Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme” (temporarily closed to accrual). Patients currently on study may continue on study provided they are informed of the new and/or modified risk information. This information should be communicated to patients already enrolled on study without waiting for IRB review/approval since this information represents a significant new finding(s) that developed during the course of the research that may relate to a patient’s willingness to continue participation and per the Office for Human Research Protections, the regulations do not require IRB review and approval of statements describing such significant new findings before they are provided to already enrolled patients. Documentation of their informed consent should be carried out according to local IRB requirements. Please see the attached risk modifications, extracted from the action letter. - Dasatinib Risk Modification Summary.doc RTOG will broadcast the action letter and amended protocol in the near future. Please be advised, in addition to the action letter amendment, RTOG will incorporate additional modifications to the protocol, at which time the study is expected to re-open to patient accrual. Please notify your affiliates that are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Sites should not contact Michelle Buado for any other reason or reply directly to this broadcast. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: February 24, 2009 SUBJECT: RTOG eNews: Nancy Soto Named New Director of Protocol Development and Regulatory Compliance RTOG eNews February 24, 2009 Nancy Soto Named New Director of Protocol Development and Regulatory Compliance Nancy Soto has been named the new director of RTOG’s Protocol Development and Regulatory Compliance Department “Nancy is a valuable addition to the RTOG administrative staff,” said Walter J. Curran, Jr., M.D., the RTOG Group Chair, and the Lawrence W. Davis Professor and Chair of the Department of Radiation Oncology in the Emory School of Medicine and Chief Medical Officer of the Emory Winship Cancer Institute. “Her background in clinical trial research in both the corporate and academic arenas have allowed her to hit-the-ground running at RTOG headquarters.” Prior to coming to RTOG Ms. Soto spent 17 years with Memorial Sloan Kettering Cancer Center in New York working in grants management and clinical trial research coordination. Most recently Ms. Soto was with Schering-Plough Corporation in their Oncology Phase IV Global Clinical Trials Management section where she was a clinical project manager for investigator-initiated studies. Ms. Soto replaces Wilma Hoffman who was promoted to the position of RTOG Senior Director last year. Contact information for Nancy Soto: nsoto@acr-arrs.org, 215-740-8876. Contact Us If you need further information or wish to be added to or removed from our mailing list please send an e-mail to shartson@acr-arrs.org. RTOG clinical trials are available at http://www.rtog.org/members/active.html. More information is available on the Web at www.rtog.org. DATE: February 20, 2009 SUBJECT: RTOG 0534 - Calendar Revisions RTOG 0534 A Phase III trial of short term androgen deprivation with pelvic lymph node or prostate bed only radiotherapy (SPPORT) in prostate cancer patients with a rising PSA after radical prostatectomy Calendar Revisions The patient calendars have been revised to reflect calendar due dates for the Quality of Life forms (CS, FA, HP, QF and SA) according to Section 12 of the protocol. Please Note: There is no NP form for this study and the protocol (section 12) will be corrected to reflect this. The CS form is the form to be used to report the results of the neurocognitive assessments (HVLT-R, the Trail Making Test and COWA) and this form is available on the RTOG web site. As noted, the calendars have been revised to reflect this data form submission change. Please notify your joint center institutions and affiliates who are not on e-mail. Roseann Bonanni, CCRP RTOG Data Management Web registration is available 24/7. Information and instructions available at https://clinicalweb1.acr-arrs.org/ClinicalRtog/faces/jsp/index.jsp DATE: February 20, 2009 SUBJECT: RTOG 0522, 2nd Closure Notice Closure Notice RTOG 0522, “A Randomized Phase III Trial of Concurrent Accelerated Radiation and Cisplatin Versus Concurrent Accelerated Radiation, Cisplatin, and Cetuximab (C225) [Followed by Surgery for Selected Patients] for Stage III and IV Head and Neck Carcinomas”, has accrued 915 patients of the required 945 patients. (A closure notice was previously broadcast on 2/4/09 when 890 patients had been accrued. The RTOG accrual report is updated weekly and is available on the RTOG web site at http://www.rtog.org/pdf_document/accruing.pdf.) Note: Due to contractual restraints and the rapid rate of accrual to this study, RTOG will broadcast that the study is closed to accrual as soon as the 945th patient is entered on study. There will be no exceptions. Please notify your affiliates who are not on e-mail. DATE: February 19, 2009 SUBJECT: RTOG (0411), 0417, 0615 & 0625 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety report(s) from NCI for BEVACIZUMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by the NCI. The Following RTOG studies involve BEVACIZUMAB: RTOG (0411) “A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER” RTOG 0417 “A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA” RTOG 0615 “A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER” RTOG 0625 “A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA” Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - Bevacizumab CCI-779, AE-1034535, Protocol E2804, -ISR.pdf - Bevacizumab CCI-779, AE-1951869, Protocol 6986, -FU1.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org <<http://www.rtog.org>> by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. DATE: February 19, 2009 SUBJECT: RTOG (0324), (0234), 0522, 0436, & 0617 PROTOCOL NOTICE: BMS, ImClone and/or NCI SAFETY REPORTS FOR CETUXIMAB RTOG has received safety report(s) from BMS, ImClone and/or NCI for CETUXIMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by BMS, ImClone, and/or NCI. The Following RTOG studies involve CETUXIMAB: RTOG (0324) "A PHASE II STUDY OF CETUXIMAB (C225) IN COMBINATION WITH CHEMORADIATION IN PATIENTS WITH STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC)" RTOG (0234) "A PHASE II RANDOMIZED TRIAL OF SURGERY FOLLOWED BY CHEMORADIOTHERAPY PLUS C225 (CETUXIMAB) FOR ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK” RTOG 0522 “A PHASE III TRIAL OF CONCURRENT ACCELERATED RADIATION AND CISPLATIN VERSUS CONCURRENT ACCELERATED RADIATION, CISPLATIN, AND CETUXIMAB (C225) FOLLOWED BY SURGERY FOR RESIDUAL DISEASE FOR STAGE III AND IV HEAD AND NECK CARCINOMAS” RTOG 0436, “A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery” RTOG 0617, “A RANDOMIZED PHASE III COMPARISON OF STANDARD- DOSE (60 Gy) VERSUS HIGHDOSE (74 Gy) CONFORMAL RADIOTHERAPY WITH CONCURRENT AND CONSOLIDATION CARBOPLATIN/PACLITAXEL IN PATIENTS WITH STAGE IIIA/IIIB NON-SMALL CELL LUNG CANCER” Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - erbitux-ib13-esr322.pdf - erbitux-ib13-esr321.pdf - erbitux-ib13-esr320.pdf - erbitux-ib13-esr322-fu01.pdf - erbitux-ib13-esr321-fu01.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org <<http://www.rtog.org>> by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. DATE: February 19, 2009 SUBJECT: RTOG Study Terminations RTOG Study Terminations The studies listed below are completed and will be terminated as of February 19, 2009. As of that date all study activity and data collection will cease, and institutions should notify their local IRBs/REBs of the terminations. Any data received at RTOG Headquarters after February 19, 2009 will be returned to the submitting institution. Brain: RTOG 0013: A Phase II Trial of Conventional Radiation Therapy Followed by Intratumoral Bleomycin Delivered Using a Refillable, Sustained Release Device (IND# 46,592) for the Treatment of Supratentorial Glioblastoma RTOG 0021: A Phase II Trial of Conventional Radiation Therapy Plus High DoseTamoxifen for the Treatment of Supratentorial Glioblastoma Multiforme (GBM) RTOG 0023: A Phase II Trial of Accelerated Radiotherapy Using Weekly Stereotactic Conformal Boosts for Supratentorial Glioblastoma Multiforme RTOG 0118: A Phase III Study of Conventional Radiation Therapy Plus Thalidomide (NSC# 66847) Versus Conventional Radiation Therapy for Multiple Brain Metastases RTOG 0119: A Randomized Phase II Study of A.M. And P.M. Melatonin for Brain Metastasis on RPA Class II Patients Head & Neck: RTOG 0421: A Phase III Trial for Locally Recurrent, Previously Irradiated Head and Neck Cancer: Concurrent Re-Irradiation and Chemotherapy Versus Chemotherapy Alone Lung: RTOG 0412: Phase III Randomized Trial of Preoperative Chemotherapy Versus Preoperative Concurrent Chemotherapy and Thoracic Radiotherapy Followed by Surgical Resection and Consolidation Chemotherapy in Favorable Prognosis Patients with Stage IIIA (N2) Non-Small Cell Lung Cancer Symptom Management: RTOG 97-14: Randomized Trial of Palliative Radiation Therapy for Osseous Metastases: A Study of Palliation of Symptoms and Quality of Life RTOG 0122: Double-Blind Study of Nutritional Intervention for the Treatment of Cancer Cachexia Using Juven® Nutritional Supplement RTOG 0435: A Randomized, Phase III, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Palifermin (NSC# 740548; IND #100,192) for the Reduction of Oral Mucositis in Patients with Locally Advanced Head and Neck Cancer Receiving Radiation Therapy with Concurrent Chemotherapy (Followed by Surgery for Selected Patients) Please notify your affiliates that are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Sites should not contact Michelle Buado for any other reason or reply directly to this broadcast. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. DATE: February 11, 2009 SUBJECT: RTOG (0324), (0234), 0522, 0436, & 0617 PROTOCOL NOTICE: BMS, ImClone and/or NCI SAFETY REPORTS FOR CETUXIMAB RTOG has received safety report(s) from BMS, ImClone and/or NCI for CETUXIMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by BMS, ImClone, and/or NCI. The Following RTOG studies involve CETUXIMAB: RTOG (0324) "A PHASE II STUDY OF CETUXIMAB (C225) IN COMBINATION WITH CHEMORADIATION IN PATIENTS WITH STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC)" RTOG (0234) "A PHASE II RANDOMIZED TRIAL OF SURGERY FOLLOWED BY CHEMORADIOTHERAPY PLUS C225 (CETUXIMAB) FOR ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK" RTOG 0522 "A PHASE III TRIAL OF CONCURRENT ACCELERATED RADIATION AND CISPLATIN VERSUS CONCURRENT ACCELERATED RADIATION, CISPLATIN, AND CETUXIMAB (C225) FOLLOWED BY SURGERY FOR RESIDUAL DISEASE FOR STAGE III AND IV HEAD AND NECK CARCINOMAS" RTOG 0436, "A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery" RTOG 0617, "A RANDOMIZED PHASE III COMPARISON OF STANDARD- DOSE (60 Gy) VERSUS HIGHDOSE (74 Gy) CONFORMAL RADIOTHERAPY WITH CONCURRENT AND CONSOLIDATION CARBOPLATIN/PACLITAXEL IN PATIENTS WITH STAGE IIIA/IIIB NON-SMALL CELL LUNG CANCER" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - erbitux-ib13-esr314-fu01.pdf - erbitux-ib13-esr306-fu02.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org <<http://www.rtog.org>> by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. DATE: February 11, 2009 SUBJECT: RTOG (0411), 0417, 0615 & 0625 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety report(s) from NCI for BEVACIZUMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by the NCI. The Following RTOG studies involve BEVACIZUMAB: RTOG (0411) "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417 "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG 0615 "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - Bevacizumab,AE-1580693, Protocol E1505, -FU1.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org <<http://www.rtog.org>> by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. DATE: February 10, 2009 SUBJECT: RTOG Newsletter - February 2009 Attached is the new edition of the RTOG Newsletter containing: Group Chair Report People in the News New Studies RTOG 0617 - High Dose RT + Cetuximab for NSCLC RTOG 0619 - Vandetanib for Post-op Head & Neck Cancer RTOG 0712 - ChemoRT for Bladder Cancer RTOG 0813 - SBRT for NSCLC Patient Advocate Introductions Top Accruing Sites RTOG Sponsors Contact Us If you need further information about articles in the RTOG Newsletter please send an e-mail to shartson@acr-arrs.org. RTOG's clinical trials are available at http://www.rtog.org/members/active.html. - RTOG NL_February09.pdf More information is available on the Web at http://www.rtog.org DATE: February 10, 2009 SUBJECT: RTOG 0625/ACRIN 6677: Re-Opened, Amended, & Updated Re-Opened to Accrual, Amended, and Updated RTOG 0625/ACRIN 6677, "A Randomized Phase II Trial of Bevacizumab With Irinotecan or Bevacizumab With Temozolomide in Recurrent Glioblastoma," has been re-opened to accrual. A protocol-specified efficacy and toxicity analysis has determined that there is sufficient evidence to proceed to the second stage of accrual. Amendment #3: Major changes include: (1) a description of the results of the efficacy and toxicity analysis; and (2) modifications to the risk profile for bevacizumab in the informed consent for consistency with the current CAEPR. Update: Various sections have been updated to current RTOG standard. Please see the complete summary of changes for the amendment and update at http://www.rtog.org/members/protocols/0625/summary_changes.html Sites can download a copy of the amended protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/protocols/0625/0625.pdf NCI policy requires that the "Version Date" on the protocol title page reflect the date the amendment was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses. The "Update Date" indicates that administrative/editorial changes were made to the protocol. Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. Expedited review is allowed; however, site IRB requirements take precedence. Since additional risks were added, RTOG recommends reconsenting patients on this trial; however, your local IRB will have the final authority. Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org <<http://www.rtog.org>> by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. DATE: February 9, 2009 SUBJECT: Calendar OPS Tool ACCESS PATIENT CALENDARS 24/7 - THE CALENDAR OPS TOOL As you know, you can view your patient(s) calendar 24 hrs/7 days a week, just as we view it at Headquarters, by accessing the RTOG Website Home Page and clicking onto SITE TOOLS at the top of the page and then clicking on OPS Tools. This tool replaces the Forms Due Reports for all RTOG institutions. You can now retrieve the calendar by specific study, case #, form or for all studies, all cases and all forms. You can retrieve the last six months, last year, last two years, as well as future information - you control the date range. You can also view the entire calendar to see all forms that are due and those that were submitted or just view forms that are due. Please use this tool on a regular basis to verify that data have been received at headquarters and to also keep informed as to what data are delinquent and need to be submitted. This is your tool to view forms which are due for your RTOG cases. Data submitted via the WEB will be credited to the calendar immediately. Please keep in mind that data submitted via the mail can take up to 4 weeks to be credited to the calendar. OPS TOOL PPT.ppt If you have general questions please contact Wendy Bergantz @(215) 574-3230. For technical support, please email websupport@acr-arrs.org DATE: February 5, 2009 SUBJECT: RTOG 0615, Closure Closure RTOG 0615, “A Phase II Study of Concurrent Chemoradiotherapy Using Three-Dimensional Conformal Radiotherapy (3D-CRT) or Intensity-Modulated Radiation Therapy (IMRT) + Bevacizumab (BV) for Locally or Regionally Advanced Nasopharyngeal Cancer”, will close to patient accrual at 5 pm today (EST), as it has met its accrual objective. (Notice of this closure was previously broadcast on 1/22/09.) Please notify your affiliates who are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Sites should not contact Michelle Buado for any other reason or reply directly to this broadcast. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. DATE: February 4, 2009 SUBJECT: RTOG (0324), (0234), 0522, 0436, & 0617 PROTOCOL NOTICE: BMS, ImClone and/or NCI SAFETY REPORTS FOR CETUXIMAB RTOG has received safety report(s) from BMS, ImClone and/or NCI for CETUXIMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by BMS, ImClone, and/or NCI. The Following RTOG studies involve CETUXIMAB: RTOG (0324) "A PHASE II STUDY OF CETUXIMAB (C225) IN COMBINATION WITH CHEMORADIATION IN PATIENTS WITH STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC)" RTOG (0234) "A PHASE II RANDOMIZED TRIAL OF SURGERY FOLLOWED BY CHEMORADIOTHERAPY PLUS C225 (CETUXIMAB) FOR ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK” RTOG 0522 “A PHASE III TRIAL OF CONCURRENT ACCELERATED RADIATION AND CISPLATIN VERSUS CONCURRENT ACCELERATED RADIATION, CISPLATIN, AND CETUXIMAB (C225) FOLLOWED BY SURGERY FOR RESIDUAL DISEASE FOR STAGE III AND IV HEAD AND NECK CARCINOMAS” RTOG 0436, “A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery” RTOG 0617, “A RANDOMIZED PHASE III COMPARISON OF STANDARD- DOSE (60 Gy) VERSUS HIGHDOSE (74 Gy) CONFORMAL RADIOTHERAPY WITH CONCURRENT AND CONSOLIDATION CARBOPLATIN/PACLITAXEL IN PATIENTS WITH STAGE IIIA/IIIB NON-SMALL CELL LUNG CANCER” Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - erbitux-ib13-esr310-fu01.pdf - erbitux-ib13-esr313-fu02.pdf - erbitux-ib13-esr319.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org <<http://www.rtog.org>> by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. DATE: February 4, 2009 SUBJECT: RTOG 0522, Closure Notice Closure Notice RTOG 0522, “A Randomized Phase III Trial of Concurrent Accelerated Radiation and Cisplatin Versus Concurrent Accelerated Radiation, Cisplatin, and Cetuximab (C225) [Followed by Surgery for Selected Patients] for Stage III and IV Head and Neck Carcinomas”, has accrued 890 patients of the required 945 patients. It is anticipated that this study will close 1 month from today. RTOG’s goal is not to exceed the required sample size. Another closure notice will be broadcast 2 weeks before the study is closed to accrual. Please notify your affiliates who are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Sites should not contact Michelle Buado for any other reason or reply directly to this broadcast. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org ; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. DATE: February 3, 2009 SUBJECT: RTOG 9813 PROTOCOL NOTICE: NEW Temozolomide Investigator Brochure now available on the website (Correction) Please Note: This is not a duplicate message, there has been a correction to the password from the message sent earlier today A NEW Investigator Brochure for Temozolomide Version: December 2008 for RTOG 9813 as well as a Summary of the Changes is now available on the RTOG website at http://www.rtog.org/investbrochure.html. In addition to the user name and password routinely used to access other confidential materials on the RTOG website, these confidential documents require the password below to gain access. The password for the New RTOG 9813 Temozolomide Investigator Brochure and Summary of Changes currently posted on our website is included below: Password: RTOG Please note that this password is case sensitive, so please type exactly as noted above DATE: February 3, 2009 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0712 Web-Based Electronic Data Submission is now available for the following form: RTOG 0712 TF Per previous Broadcasts, web-based data submission became mandatory as of May 14, 2007 for all forms available for web-entry for all cases enrolled through RTOG. A complete listing of forms available for web data submission is available at http://www.rtog.org/members/webreg.html For technical support with web data submission, please email websupport@acr-arrs.org. Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214. Please notify your joint center institutions and affiliates who are not on e-mail. Elaine Motyka-Welsh, RN, MSN, CCRP Research Associate Web registration is available 24/7. Information and instructions available at https://clinicalweb1.acr-arrs.org/ClinicalRtog/faces/jsp/index.jsp DATE: February 3, 2009 SUBJECT: Investigator Brochure Update Alert Notification of updated Investigator Brochures has recently been received by RTOG for the following studies: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) The IB & Summary of Changes for the Temozolomide used in this study is available on the RTOG Website at http://www.rtog.org/investbrochure.html. Please refer to the Protocol Notification broadcast sent 2/3/09 for applicable password information RTOG 0627 "PHASE II TRIAL OF DASATINIB IN PATIENTS WITH RECURRENT GLIOBLASTOMA MULTIFORME" The IB for the Dasatinib used in this study can be obtained from the NCI/PMB by contacting the IB Coordinator at ibcoordinator@mail.nih.gov or (301) 496-5725 DATE: February 3, 2009 SUBJECT: RTOG 9813 PROTOCOL NOTICE: NEW Temozolomide Investigator Brochure now available on the website A NEW Investigator Brochure for Temozolomide Version: December 2008 for RTOG 9813 as well as a Summary of the Changes is now available on the RTOG website at - http://www.rtog.org/investbrochure.html. In addition to the user name and password routinely used to access other confidential materials on the RTOG website, these confidential documents require the password below to gain access. The password for the New RTOG 9813 Temozolomide Investigator Brochure and Summary of Changes currently posted on our website is included below: Password: RTOG Cancer Group Please note that this password is case sensitive, so please type exactly as noted above DATE: January 30, 2009 SUBJECT: RTOG 0813, Activated Activated RTOG 0813, "Seamless Phase I/II Study of Stereotactic Lung Radiotherapy (SBRT) for Early Stage, Centrally Located, Non-Small Cell Lung Cancer (NSCLC) in Medically Inoperable Patients" The following items are available on the RTOG web site A copy of the protocol for IRB review: http://www.rtog.org/members/protocols/0813/0813.pdf The sample consent: http://www.rtog.org/members/protocols/0813/consent.html Forms for the study: http://www.rtog.org/members/forms/0813/main.html A diagram for avoidance of organs at risk: http://www.rtog.org/members/protocols/0813/0813%20OAR%20avoid%20diagram.ppt NOTE: This is a limited participation study. Due to the importance of timely data quality with regards to assigning doses to new cases for this study, institutions must receive approval for participation in the study from RTOG Headquarters. See Section 5.1 of the protocol for details. Sites can find the "application to participate" on the RTOG web site at http://www.rtog.org/members/protocols/0813/0813%20Application%20to%20participate.doc Regulatory Note: NCI policy requires that the "Version Date" of the protocol reflect the date that the protocol was submitted by RTOG to NCI; therefore, the version date and the activation date on the protocol title page are not the same. The "Update Date" (the same as the activation date) indicates that administrative changes were made to the protocol after NCI approval; these changes are detailed in a summary of changes that can be accessed at http://www.rtog.org/members/protocols/0813/summary_changes.html Please notify your affiliates that are not on e-mail. DATE: January 30, 2009 SUBJECT: RTOG 0518, Closure Closure RTOG 0518, "A Phase III Randomized Trial to Evaluate the Efficacy of Zometa® for the Prevention of Osteoporosis and Associated Fractures in Patients Receiving Radiation Therapy and Long Term LHRH Agonists for High-Grade and/or Locally Advanced Prostate Cancer”, will close to patient accrual at 5:00 PM today (EST), as the study has not met its accrual objective. Please notify your affiliates who are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Sites should not contact Michelle Buado for any other reason or reply directly to this broadcast. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: January 29, 2009 SUBJECT: RTOG (0324), (0234), 0522, 0436, & 0617 PROTOCOL NOTICE: BMS, ImClone and/or NCI SAFETY REPORTS FOR CETUXIMAB RTOG has received safety report(s) from BMS, ImClone and/or NCI for CETUXIMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by BMS, ImClone, and/or NCI. The Following RTOG studies involve CETUXIMAB: RTOG (0324) "A PHASE II STUDY OF CETUXIMAB (C225) IN COMBINATION WITH CHEMORADIATION IN PATIENTS WITH STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC)" RTOG (0234) "A PHASE II RANDOMIZED TRIAL OF SURGERY FOLLOWED BY CHEMORADIOTHERAPY PLUS C225 (CETUXIMAB) FOR ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK" RTOG 0522 "A PHASE III TRIAL OF CONCURRENT ACCELERATED RADIATION AND CISPLATIN VERSUS CONCURRENT ACCELERATED RADIATION, CISPLATIN, AND CETUXIMAB (C225) FOLLOWED BY SURGERY FOR RESIDUAL DISEASE FOR STAGE III AND IV HEAD AND NECK CARCINOMAS" RTOG 0436, "A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery" RTOG 0617, "A RANDOMIZED PHASE III COMPARISON OF STANDARD- DOSE (60 Gy) VERSUS HIGHDOSE (74 Gy) CONFORMAL RADIOTHERAPY WITH CONCURRENT AND CONSOLIDATION CARBOPLATIN/PACLITAXEL IN PATIENTS WITH STAGE IIIA/IIIB NON-SMALL CELL LUNG CANCER" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - erbitux-ib13-esr313-fu01.pdf - erbitux-ib13-esr318.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org <<http://www.rtog.org>> by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. DATE: January 29, 2009 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0537 Web-based Electronic Data Submission Is Now Available For RTOG # 0537 F1 - Follow-up Form A Phase II/III Study Comparing Acupuncture-like Transcutaneous Electrical Nerve Stimulation (ALTENS) Versus Pilocarpine in Treating Early Radiation-Induced Xerostomia Per previous Broadcasts, web-based data submission became mandatory as of May 14, 2007 for all forms available for web-entry for all cases enrolled through RTOG. A complete listing of forms available for web data submission is available at http://www.rtog.org/members/webreg.html For technical support with web data submission, please email websupport@acr-arrs.org. Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214. Please notify your joint center institutions and affiliates who are not on e-mail. Roseann Bonanni, CCRP RTOG Data Management DATE: January 27, 2009 SUBJECT: RTOG (0324), (0234), 0522, 0436, & 0617 PROTOCOL NOTICE: BMS, ImClone and/or NCI SAFETY REPORTS FOR CETUXIMAB RTOG has received safety report(s) from BMS, ImClone and/or NCI for CETUXIMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by BMS, ImClone, and/or NCI. The Following RTOG studies involve CETUXIMAB: RTOG (0324) "A PHASE II STUDY OF CETUXIMAB (C225) IN COMBINATION WITH CHEMORADIATION IN PATIENTS WITH STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC)" RTOG (0234) "A PHASE II RANDOMIZED TRIAL OF SURGERY FOLLOWED BY CHEMORADIOTHERAPY PLUS C225 (CETUXIMAB) FOR ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK" RTOG 0522 "A PHASE III TRIAL OF CONCURRENT ACCELERATED RADIATION AND CISPLATIN VERSUS CONCURRENT ACCELERATED RADIATION, CISPLATIN, AND CETUXIMAB (C225) FOLLOWED BY SURGERY FOR RESIDUAL DISEASE FOR STAGE III AND IV HEAD AND NECK CARCINOMAS" RTOG 0436, "A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery" RTOG 0617, "A RANDOMIZED PHASE III COMPARISON OF STANDARD- DOSE (60 Gy) VERSUS HIGHDOSE (74 Gy) CONFORMAL RADIOTHERAPY WITH CONCURRENT AND CONSOLIDATION CARBOPLATIN/PACLITAXEL IN PATIENTS WITH STAGE IIIA/IIIB NON-SMALL CELL LUNG CANCER" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - erbitux-ib13-esr308-fu01.pdf - erbitux-ib13-esr314.pdf - erbitux-ib13-esr315.pdf - erbitux-ib13-esr316.pdf - erbitux-ib13-esr317.pdf - erbitux-ib13-esr311-fu01.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org <<http://www.rtog.org>> by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. DATE: January 27, 2009 SUBJECT: RTOG (0411), 0417, 0615 & 0625 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety report(s) from NCI for BEVACIZUMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by the NCI. The Following RTOG studies involve BEVACIZUMAB: RTOG (0411) "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417 "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG 0615 "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - Bevacizumab, AE-1729567, Protocol E5103, -FU1.pdf - Bevacizumab, AE-1580693, Protocol E1505, -ISR.pdf - Bevacizumab, AE- 1324148, Protocol E5103, -ISR.pdf - Bevacizumab Investigator Notification Genentech Manufacturer Report 273064 January 9 2009.pdf - Bevacizumab, AE-1996104, Protocol GOG-0218, -ISR.pdf - Bevacizumab Oxaliplatin, AE-1118620, Protocol E5204, -FU1.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org <<http://www.rtog.org>> by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. DATE: January 26, 2009 SUBJECT: Statistical Analyses on RTOG 9813 and 0525 ALL INSTITUTIONS PARTICIPATING IN RTOG 9813 AND RTOG 0525 Important statistical analyses are being planned on the above studies. Please review your OPS tool and submit all outstanding data due through February 15th, 2009 to RTOG Headquarters by February 27th, 2009. Please notify your joint center institutions and affiliates who are not on e-mail. Thank you for your cooperation. Barbara Kaiser, RN, CCRP RTOG Data Management DATE: January 22, 2009 SUBJECT: RTOG 0615, Closure Notice Closure Notice RTOG 0615, "A Phase II Study of Concurrent Chemoradiotherapy Using Three-Dimensional Conformal Radiotherapy (3D-CRT) or Intensity-Modulated Radiation Therapy (IMRT) + Bevacizumab (BV) for Locally or Regionally Advanced Nasopharyngeal Cancer", will close to patient accrual on Thursday, February 5th, as it has met its accrual objective. Please notify your affiliates who are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Sites should not contact Michelle Buado for any other reason or reply directly to this broadcast. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org ; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. DATE: January 21, 2009 SUBJECT: RTOG 0518, Closure Notice Closure Notice RTOG 0518, "A Phase III Randomized Trial to Evaluate the Efficacy of Zometa® for the Prevention of Osteoporosis and Associated Fractures in Patients Receiving Radiation Therapy and Long Term LHRH Agonists for High-Grade and/or Locally Advanced Prostate Cancer", will close to patient accrual on Friday, January 30th, as the study has not met its accrual objective. Please notify your affiliates who are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Sites should not contact Michelle Buado for any other reason or reply directly to this broadcast. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org ; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. DATE: January 14, 2009 SUBJECT: Form Revision Notice & Web Data Submission Update - RTOG 0518 Web-based Electronic Data Submission RTOG 0518 Phase III randomized trial to evaluate the efficacy of Zometa® for the prevention of osteoporosis and associated fractures in patients receiving radiation therapy and long term LHRH agonists for high-grade and/or locally advanced prostate cancer Per previous Broadcasts, web-based data submission became mandatory as of May 14, 2007 for all forms available for web-entry for all cases enrolled through RTOG. A complete listing of forms available for web data submission is available at http://www.rtog.org/members/webreg.html For technical support with web data submission, please email websupport@acr-arrs.org. Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214. Forms Revision Notice The following form for this study has been revised. Download the new version from the RTOG web site at http://www.rtog.org/pdf_forms.html?members/forms=0518/0518f1.pdf The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date F1 F1b 12/30/08 Changes-Q#6-revised to include 9-unknown Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions received on or after January 31, 2009 will be returned to the site for transcription. Please notify your joint center institutions and affiliates who are not on e-mail. Roseann Bonanni, CCRP, RTOG Data Management DATE: January 13, 2009 SUBJECT: Special Pre-Meeting Edition of the RTOG RA Reporter Now Available The Special Pre-Meeting (Winter 2009) Edition of the RTOG RA Reporter is now available on the RTOG website (RA Corner &rarr RA Reporter) It is also available at the attached link: http://www.rtog.org/pdf_document/RAreporter.pdf DATE: January 13, 2009 SUBJECT: RTOG 9601, Amended Amended RTOG 9601, "A Phase III Trial Of Radiation Therapy With Or Without Casodex In Patients With PSA Elevation Following Radical Prostatectomy For pT3N0 Carcinoma Of The Prostate", Amendment #5 Please see the complete Summary of Changes at http://www.rtog.org/members/protocols/96-01/summary_changes.html Sites can download a copy of the protocol for IRB review at http://www.rtog.org/members/protocols/96-01/96-01.pdf NCI policy requires that the "Version Date" on the protocol title page reflect the date the amendment was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses. Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. Expedited review is allowed; however, site IRB requirements take precedence. Please notify your affiliates that are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org. Sites should not contact Michelle Buado for any other reason or reply directly to this broadcast. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org ; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. DATE: January 13, 2009 SUBJECT: Form Revision Notice & Web-Based Electronic Data Submission Update - RTOG 0622 Web-based Electronic Data Submission RTOG # 0622 Phase II trial of Samarium 153 followed by salvage prostatic fossa 3D-CRT or IMRT irradiation in high risk prostate cancer after prostatectomy Per previous Broadcasts, web-based data submission became mandatory as of May 14, 2007 for all forms available for web-entry for all cases enrolled through RTOG. A complete listing of forms available for web data submission is available at http://www.rtog.org/members/webreg.html For technical support with web data submission, please email websupport@acr-arrs.org. Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214. DATE: January 12, 2009 SUBJECT: RTOG eNews: Anthony M. Magliocco, MD, Named New RTOG Pathology Committee Chair RTOG eNews January 12, 2009 Anthony M. Magliocco, MD, Named New RTOG Pathology Committee Chair Anthony M. "Tony" Magliocco, M.D., has been appointed RTOG's Pathology Committee. Dr. Magliocco is the director of the Translational Laboratory at the Tom Baker Cancer Centre in Alberta, Canada and an associate professor in the department of Oncology, Pathology & Laboratory Medicine at the University of Calgary. "Dr. Magliocco is an internationally respected molecular pathologist with a strong clinical and research background. He has been actively involved in RTOG research for a number of years. The translational group in Calgary has become a center of excellence for protein expression using the HistoRx/Aqua technology and Dr. Magliocco is currently directing studies aimed at identifying novel molecular markers of tumor response to therapies in several different cancers, including breast cancer and gynecological malignancies," said RTOG Group Chair Walter J. Curran, Jr., M.D. Dr. Magliocco succeeds Mahul B. Amin, M.D., of Cedars Sinai Medical Center in Los Angeles as RTOG Pathology Committee chair. For the complete announcement of Dr. Magliocco's appointment please see the RTOG Web site. < press release > Survey on Collecting Patient-reported AEs in Oncology Trials Reminder - RTOG clinical investigators, CRAs, and research staff are asked to complete a brief online survey pertaining to the NCI contract to create a system for patients to self-report their own adverse symptoms in oncology clinical trials (including radiation oncology trials which use the CTCAE). Towards developing this system, we wish to elicit the impressions of research personnel about how such a system would ideally function within the context of trials, and what barriers exist to implementation. Answers are automatically anonymous and will be collected until January 31st. To take the survey please click the link below: http://www.surveymonkey.com/s.aspx?sm=jVB_2fcUvZmCk6Po9PLEYJIA_3d_3d For more information about this project please contact Deborah W Bruner, PhD (wbruner@nursing.upenn.edu). Announcements Meeting Book on Web Site The RTOG January 2009 Semiannual Meeting Book, containing the group progress reports, meeting agendas, membership lists, and other important group information, has been posted on the RTOG Web site. You will need your RTOG Username and Password to access the book. Copies of the meeting book will be available at the RTOG Semiannual Meeting in New Orleans in CD and hard copy format. <Meeting Book> Special Meeting Events RTOG 0537 ALTENS Training Thursday, 2:00 PM - Oakley Room Friday, 11:00 AM - Oakley Room DNA Repair Symposium - Friday, 9:00 AM - 1:00 PM, Grand Ballroom C, Box lunches provided.< DNA Agenda > RTOG 0617 Kick-off Breakfast - Saturday, 7:00 - 8:30 AM Scientific Session - Saturday, 1:00 - 2:00 PM - Four ASTRO presentations <Agenda> Plenary Session - Saturday, 2:00 - 3:00 PM <Agenda> Maura Gillison, MD, PhD, Ohio State University - "HPV as a Biomarker for Treatment Response and Survival for Head and Neck Cancer." Walter J. Curran, Jr., MD, RTOG Group Chair - Group Update Michael T. Milano, MD, PhD, University of Rochester, Simon Kramer New Investigator Award - "Curative-intent Stereotactic Body Radiation Therapy in Patients with Five or Fewer Oligometastic Lesions," Contact Us If you need further information or wish to be added to or removed from our mailing list please send an e-mail to shartson@acr-arrs.org. RTOG clinical trials are available at http://www.rtog.org/members/active.html. More information is available on the Web at www.rtog.org. The Radiation Therapy Oncology Group (RTOG) is administered by the American College of Radiology (ACR) and is located in the ACR Clinical Research Center in Philadelphia, PA. RTOG is a multi-institutional international clinical cooperative group funded primarily by National Cancer Institute grants CA21661, CA32115 and CA37422. RTOG has 40 years of experience in conducting clinical trials and is comprised of over 300 major research institutions in the United States, Canada, and internationally. The group currently is currently accruing to 40 studies that involve radiation therapy alone or in conjunction with surgery and/or chemotherapeutic drugs or which investigate quality of life issues and their effects on the cancer patient. DATE: January 9, 2009 SUBJECT: RTOG (0411), 0417, 0615 & 0625 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB -RESEND RTOG has received safety report(s) from NCI for BEVACIZUMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by the NCI. The Following RTOG studies involve BEVACIZUMAB: RTOG (0411) "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417 "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG 0615 "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - Bevacizumab and CCI-779, AE- 1803957, Protocol GOG-0118G, -FU1.pdf - Bevacizumab & CCI-779, AE-1205368, Protocol E2804,-FU1.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org <<http://www.rtog.org>> by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. DATE: January 9, 2009 SUBJECT: RTOG (0324), (0234), 0522, 0436, & 0617 PROTOCOL NOTICE: BMS, ImClone and/or NCI SAFETY REPORTS FOR CETUXIMAB RTOG has received safety report(s) from BMS, ImClone and/or NCI for CETUXIMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by BMS, ImClone, and/or NCI. The Following RTOG studies involve CETUXIMAB: RTOG (0324) "A PHASE II STUDY OF CETUXIMAB (C225) IN COMBINATION WITH CHEMORADIATION IN PATIENTS WITH STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC)" RTOG (0234) "A PHASE II RANDOMIZED TRIAL OF SURGERY FOLLOWED BY CHEMORADIOTHERAPY PLUS C225 (CETUXIMAB) FOR ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK" RTOG 0522 "A PHASE III TRIAL OF CONCURRENT ACCELERATED RADIATION AND CISPLATIN VERSUS CONCURRENT ACCELERATED RADIATION, CISPLATIN, AND CETUXIMAB (C225) FOLLOWED BY SURGERY FOR RESIDUAL DISEASE FOR STAGE III AND IV HEAD AND NECK CARCINOMAS" RTOG 0436, "A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery" RTOG 0617, "A RANDOMIZED PHASE III COMPARISON OF STANDARD- DOSE (60 Gy) VERSUS HIGHDOSE (74 Gy) CONFORMAL RADIOTHERAPY WITH CONCURRENT AND CONSOLIDATION CARBOPLATIN/PACLITAXEL IN PATIENTS WITH STAGE IIIA/IIIB NON-SMALL CELL LUNG CANCER" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - erbitux-ib13-esr303-fu01.pdf - erbitux-ib13-esr312-fu01.pdf - erbitux-ib13-esr312.pdf - erbitux-ib13-esr311.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org <<http://www.rtog.org>> by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. DATE: January 9, 2009 SUBJECT: RTOG (0411), 0417, 0615 & 0625 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety report(s) from NCI for BEVACIZUMAB Please note: If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by the NCI. The Following RTOG studies involve BEVACIZUMAB: RTOG (0411) "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417 "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG 0615 "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - Bevacizumab and CCI-779, AE- 1803957, Protocol GOG-0118G, -FU1.pdf - Bevacizumab & CCI-779, AE-1205368, Protocol E2804,-FU1.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org <<http://www.rtog.org>> by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. DATE: January 9, 2009 SUBJECT: RTOG 0627 PROTOCOL NOTICE: BMS and/or NCI SAFETY REPORTS FOR DASATINIB RTOG has received safety report(s) from BMS and/or NCI for DASATINIB If any of the attached reports are follow-up they will contain all of the information from the initial report(s), which may not have been provided by BMS, ImClone, and/or NCI. The Following RTOG studies involve DASATINIB: RTOG 0627 "PHASE II TRIAL OF DASATINIB IN PATIENTS WITH RECURRENT GLIOBLASTOMA MULTIFORME" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - dasatinib-ib08-esr01.pdf - dasatinib-ib08-esr01-fu01.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@acr-arrs.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org <<http://www.rtog.org>> by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. DATE: January 9, 2009 SUBJECT: RTOG eNews: Meeting Book on Web Site, Meeting Announcements, New Publication RTOG eNews January 9, 2009 RTOG Meeting Book Posted on Web Site The RTOG January 2009 Semiannual Meeting Book , containing the group progress reports, meeting agendas, membership lists, and other important group information, has been posted on the RTOG Web site. You will need your RTOG Username and Password to access the book. Copies of the meeting book will be available at the RTOG Semiannual Meeting in New Orleans in CD and hard copy format. <meeting book> RTOG Semiannual Meeting Special Events Mark your meeting calendar! RTOG 0537 ALTENS Training Thursday, 2:00 PM - Oakley Room Friday, 11:00 AM - Oakley Room DNA Repair Symposium Friday, 9:00 AM - 1:00 PM, Grand Ballroom C, Box lunches provided. RTOG 0617 Kick-off Breakfast Saturday, 7:00 - 8:30 AM Scientific Session Saturday, 1:00 - 2:00 PM - Four ASTRO presentations Plenary Session Saturday, 2:00 - 3:00 PM Maura Gillison, MD, PhD, Ohio State University - "HPV as a Biomarker for Treatment Response and Survival for Head and Neck Cancer." Walter J. Curran, Jr., MD, RTOG Group Chair - Group Update Michael T. Milano, MD, PhD, University of Rochester, Simon Kramer New Investigator Award - "Curative-intent Stereotactic Body Radiation Therapy in Patients with Five or Fewer Oligometastic Lesions," Recent Publication Androgen Deprivation Therapy Not Related to Cardiovascular Death - RTOG 8531 Results RTOG researchers led by Jason A Efstathiou, MD, of Massachusetts General Hospital, found that gonadotropin-releasing hormone (GnRH) agonists do not seem to increase cardiovascular mortality in men with locally advanced prostate cancer. Between 1987 and 1992, 945 men with locally advanced prostate cancer registered on RTOG 8531 were randomly assigned to receive radiotherapy and adjuvant goserelin or radiotherapy alone. With a median follow-up of 8.1 years and 117 cardiovascular-related deaths, the investigators found that the 9-year cardiovascular mortality rate for men treated with adjuvant goserelin was 8.4% v 11.4% for men treated without adjuvant goserelin. The lack of an apparent treatment-related detrimental effect was similarly seen after censoring patients at time of salvage GnRH agonist therapy and when using alternative definitions of cardiovascular mortality. The results of the trial, RTOG 8531, were published in the January 1, 2009 issue of the Journal of Clinical Oncology ( J Clin Oncol. 2009 Jan 1;27(1):92-9). The publication abstract and access to the full publication is available from the JCO. These results were originally presented at the 2007 American Society for Therapeutic Radiology and Oncology Annual Meeting in Los Angeles and the 2008 American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco. <abstract > Announcements Semiannual Meeting Registration It is still not too late to fax in your registration for the RTOG Semiannual Meeting that will be held at the Sheraton New Orleans Hotel January 15 - 18, 2009. Complete <meeting agendas> and <registration materials>are available on the RTOG Web site. Make your reservations now! <meeting materials> Contact Us If you need further information or wish to be added to or removed from our mailing list please send an e-mail to shartson@acr-arrs.org. RTOG clinical trials are available at http://www.rtog.org/members/active.html. More information is available on the Web at www.rtog.org. The Radiation Therapy Oncology Group (RTOG) is administered by the American College of Radiology (ACR) and is located in the ACR Clinical Research Center in Philadelphia, PA. RTOG is a multi-institutional international clinical cooperative group funded primarily by National Cancer Institute grants CA21661, CA32115 and CA37422. RTOG has 40 years of experience in conducting clinical trials and is comprised of over 300 major research institutions in the United States, Canada, and internationally. The group currently is currently accruing to 40 studies that involve radiation therapy alone or in conjunction with surgery and/or chemotherapeutic drugs or which investigate quality of life issues and their effects on the cancer patient. DATE: January 8, 2009 SUBJECT: RTOG Philadelphia RA Orientations The RTOG Registration Desk will be closed during the following ACR office holidays: Martin Luther King, Jr. Day The office will be closed all day on Monday, January 19th in observance of Martin Luther King, Jr. Day. Inauguration Day The office will be closed all day on Tuesday, January 20th in observance of Inauguration Day. The office will reopen at 8:30 a.m. on Wednesday, January 21st. Studies using web registration only may have cases registered via the RTOG web site, as usual. DATE: January 7, 2009 SUBJECT: RTOG Philadelphia RA Orientations Registration for the next Philadelphia RA Orientation, scheduled for February 5 and 6, 2009, is full and closed to further registrations. Thank you for your enthusiastic response! The next two day Philadelphia Orientation is scheduled for April 16 & 17, 2009. The schedule and information regarding upcoming RA Orientations can be found on the RA Corner section of the RTOG web site @ http://www.rtog.org/members/RAcorner.html Web registration is available 24/7. Information and instructions available at DATE: January 6, 2009 SUBJECT: RTOG eNews: Meeting Awards, ALTENS Training, Corporate Meeting Sponsors, PRO AE Survey RTOG eNews January 8, 2009 RTOG 0537 ALTENS Training Sessions in New Orleans Dr. Raimond Wong, principal investigator of RTOG 0537 "A Phase II/III Study Comparing Acupuncture-like Transcutaneous Electrical Nerve Stimulation (ALTENS) Versus Pilocarpine in Treating Early Radiation-Induced Xerostomia," will conduct two training sessions on the use of the ALTENS device. The sessions are scheduled for: Thursday, January 15th, 2:00 PM - Oakley Room Friday, January 16th, 11:00 AM - Oakley Room Interested investigators and clinical research associates are welcome to attend either session. If possible, please send an e-mail to Sharon Hartson (shartson@acr-arrs.org) so we can judge attendance. Also note that a video on the use of the ALTENS device and a study slide set on the protocol are available on the RTOG Web site. RTOG 0537 video RTOG 0537 slide set RTOG Meeting Awardees Simon Kramer New Investigator Award Michael T. Milano, MD, PhD, University of Rochester - Dr. Milano will present the results of his research, "Curative-intent Stereotactic Body Radiation Therapy in Patients with Five or Fewer Oligometastic Lesions," during the Plenary Session at the RTOG semiannual meeting on January 17th. Robert Ginsberg Surgical Oncology Award Constantinos G. Hadjipanayis, MD, PhD, Emory University Resident Travel Awards Felix Feng, MD, University of Michigan Guila Delouya, MD, CHUM-Notre-Dame Hospital First Meeting Medical Oncology Faculty Omer Kucuk, MD, Emory University James Philip Stevenson, MD, University of Pennsylvania First Meeting Surgical Oncology Faculty Neil D. Gross, MD, Oregon Health and Science University Steven J. Wang, MD, University of California San Francisco Thank you to our Corporate Meeting Supporters! Sponsors Bristol-Myers Squibb Pfizer Sanofi~Aventis Contributors Amgen, Inc. AstraZeneca Pharmaceuticals Elekta, Inc. Eli Lilly and Company General Electric OSI Pharmaceuticals, Inc. Survey on Collecting Patient-reported AEs in Oncology Trials RTOG clinical investigators, CRAs, and research staff are asked to complete a brief online survey pertaining to the NCI contract to create a system for patients to self-report their own adverse symptoms in oncology clinical trials (including radiation oncology trials which use the CTCAE). Towards developing this system, we wish to elicit the impressions of research personnel about how such a system would ideally function within the context of trials, and what barriers exist to implementation. Answers are automatically anonymous and will be collected until January 31st. To take the survey please click the link below: http://www.surveymonkey.com/s.aspx?sm=jVB_2fcUvZmCk6Po9PLEYJIA_3d_3d For more information about this project please contact Deborah W Bruner, PhD ( wbruner@nursing.upenn.edu ). DNA Repair Symposium & Scientific Session Agenda Posted The agendas for the DNA Repair Symposium (9:00 AM - 12:30 PM, 1/16/09) and the Scientific/Plenary Session (1:00 - 3:00, 1/17/09) have been posted on the RTOG Web site. Maura Gillison, MD, PhD, will give the RTOG Keynote Address at the Plenary Session on "HPV as a Biomarker for Treatment Response and Survival for Head and Neck Cancer." The scientific session will consist of four presentations originally ASTRO in September 2008. <DNA Repair Agenda> <Scientific Session Agenda> Full Member Principal Investigator Chair Elected Elizabeth Gore, MD, of the Medical College of Wisconsin was elected by the Full Member Principal Investigators to be their representative on the RTOG Steering and Executive Committees. Announcements Semiannual Meeting Registration It is still not too late to fax in your registration for the RTOG Semiannual Meeting that will be held at the Sheraton New Orleans Hotel January 15 - 18, 2009. Complete meeting agendas and registration materials are available on the RTOG Web site. Make your reservations now! http://www.rtog.org/meeting/main.html Contact Us If you need further information or wish to be added to or removed from our mailing list please send an e-mail to shartson@acr-arrs.org. RTOG clinical trials are available at http://www.rtog.org/members/active.html. More information is available on the Web at www.rtog.org. The Radiation Therapy Oncology Group (RTOG) is administered by the American College of Radiology (ACR) and is located in the ACR Clinical Research Center in Philadelphia, PA. RTOG is a multi-institutional international clinical cooperative group funded primarily by National Cancer Institute grants CA21661, CA32115 and CA37422. RTOG has 40 years of experience in conducting clinical trials and is comprised of over 300 major research institutions in the United States, Canada, and internationally. The group currently is currently accruing to 40 studies that involve radiation therapy alone or in conjunction with surgery and/or chemotherapeutic drugs or which investigate quality of life issues and their effects on the cancer patient. DATE: January 6, 2009 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0324 Web-based Electronic Data Submission Is Now Available For RTOG # 0324 F1 - Follow-up Form Per previous Broadcasts, web-based data submission became mandatory as of May 14, 2007 for all forms available for web-entry for all cases enrolled through RTOG. A complete listing of forms available for web data submission is available at http://www.rtog.org/members/webreg.html. For technical support with web data submission, please email websupport@acr-arrs.org. Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214. Please notify your joint center institutions and affiliates who are not on e-mail. Mary Gramkowski, RN, BA, CCRP RTOG Data Management Web registration is available 24/7. Information and instructions available at DATE: January 6, 2009 SUBJECT: RTOG 0417, Updated Updated RTOG 0417, "Phase II Study of Bevacizumab in Combination with Definitive Radiotherapy and Cisplatin Chemotherapy in Untreated Patients with Locally Advanced Cervical Carcinoma." Sections 3.2.22, 11.1, 13.4.5, and Appendix II have been updated. Sites can access the complete summary of changes at http://www.rtog.org/members/protocols/0417/summary_changes.html Sites can download a copy of the updated protocol by accessing the RTOG web site at http://www.rtog.org/members/protocols/0417/0417.pdf The "Update Date" on the protocol title page indicates that editorial/administrative changes were made to the protocol; for clarity, the broadcast date of the update is provided in parentheses at the top of the summary of changes for the update. IRB review of an update is not required; however, these changes must be reported to site IRBs. Please notify your affiliates that are not on e-mail. Sites should not contact Michelle Buado for any other reason or reply directly to this broadcast. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select the member information tab, and click Headquarters Information and Telephone Listings. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department. DATE: January 5, 2009 SUBJECT: RTOG 0127/ECOG E5597: Extension of Expiration Date for Selenized Yeast and Placebo Yeast drug products RTOG sites participating in RTOG 0127/ECOG E5597, "Phase III Chemoprevention Trial of Selenium Supplementation in Persons with Resected Stage I Non-Small Cell Lung Cancer" Per the ECOG Drug Team and ECOG Coordinating Center: Representative samples of both the selenized yeast and placebo yeast drug products provided for use in ECOG E5597 underwent analytical testing in compliance with cGMP requirements. Azopharma Contract Pharmaceutical Services, Mirimar, Fla, performed the testing on October 22, 2008. Validation of the testing methods was based on ICH guidelines and the acceptance criteria were based on cGMP requirements for drug products. The test parameters included appearance, assay for drug substance content (bound and free selenium), content uniformity, microbial limits and dissolution. The results of all test parameters for both the active and placebo drug products continue to meet the acceptance criteria and provide evidence that they remain suitable for their intended use. As a result, the expiration date for the current lots of the selenized yeast 200 mcg tablets and matching placebo has been extended to January 31, 2010. The analytical testing is scheduled to be routinely performed throughout the course of this trial and the expiration date is subject to further extension based on the results. If you have any questions, please contact the ECOG Drug Team at the ECOG Coordinating Center at (617) 632-3610 or ecog.drugorder@jimmy.harvard.edu. Please notify your affiliates that are not on e-mail. Sites should not contact Michelle Buado for any other reason or reply directly to this broadcast. Institutions can share a comment or ask a question by accessing th