Member Update FUTURE MEETINGS: June 17-20, 2010 at Loews Philadelphia Hotel, Philadelphia, PA DATE: March 9, 2010 SUBJECT: RTOG 0235/ACRIN 6668, Amended Amended RTOG 0235/ACRIN 6668, "Positron Emission Tomography Pre- and Post-treatment Assessment for Locally Advanced Non-small Cell Lung Carcinoma," (a closed study) Amendment 7: Updated contact information for the Study Chair, Nuclear Medicine Physics Co-Chair, and Statistician. Note: This study is coordinated by ACRIN. Please ACRIN's e-mail and attachments below. If you have any questions about this amendment, please contact Martha L. Heckel, ACRIN Protocol Associate (contact information below) Please notify your affiliates that are not on e-mail. ACRIN's e-mail and attachments NCI/CTEP has approved Amendment 7 for ACRIN 6668 (version date March 2, 2010). Please see the attached Amendment 7 materials: tracked and master protocols, Summary of Changes document, Word document for Informed Consent Form template (content unchanged), and CTEP approval letter. The revisions in Amendment 7 comprise: update to contact information for the trial PI, update in name to one of the co-chairs, a change in statistician, and a typo correction. Attached are: 1) The final amended protocol 2) The final version of the protocol with all changes tracked 3) A summary of changes describing the modifications made in Amendment 7 4) A Microsoft Word version of the informed consent 5) CTEP's approval letter. Please submit the amended protocol to your IRB within 60 working days from today. Please contact your IRB coordinator for guidance and for your IRB's policies on the type of review and approval needed for an amendment of this nature. Once you have received approval from your IRB, please fax the IRB approval letter and the revised consent form to the attention of the trial Monitor, Josephine Schloesser, at the fax number listed below. Please include your name, the ACRIN study number (6668), your ACRIN site number, and the amendment number/protocol version date. Please feel free to contact me with any questions. Martha L. Heckel Protocol Associate American College of Radiology Imaging Network 1818 Market St., Suite 1600 Philadelphia, PA 19103 Ph: 215-574-3169 Fax: 215-717-0936 - ACRIN6668_Amend7_master_030210.pdf - ACRIN6668_Amend7_tracked_030210_FINAL.PDF - SOC-ACRIN6668_Amend7_030210.pdf - PACRIN-6668A08Approval01.pdf - Informed_Consent-ACRIN6668_Amend7_030210.doc DATE: March 9, 2010 SUBJECT: CALGB 30610/RTOG 0538, Amended Amended CALGB 30610/RTOG 0538, "Phase III Comparison Of Thoracic Radiotherapy Regimens In Patients With Limited Small Cell Lung Cancer Also Receiving Cisplatin And Etoposide", CALGB Update 4: Sections 6.3.1, 7.0, and 18 (model consent form) were amended. Note: This is a CALGB-coordinated study in which RTOG is participating. RTOG sites can download a copy of the protocol and update 4 for IRB review by accessing the CTSU web site at www.ctsu.org and going to the CTSU members' site (requires CTSU user name and password). Click on the "Protocols" tab and search by Lead Organization or protocol number. Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. If the 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. Sites must submit IRB approval for the amendment to CTSU. Please notify your affiliates that are not on e-mail. DATE: March 8, 2010 SUBJECT: Form Revision Notice - RTOG 0825 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 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=0825/0825CS.pdf The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date CS: Neurocognitive Evaluation Summary Form    CSa     2/16/10   Changes Made: Trail Making Test Results (Sample A): Question added: "last # correctly reached if not completed" Trail Making Test Results (Sample B): Question added: "last # or letter correctly reached if not completed" Discard obsolete versions and commence use of the revised edition immediately. Obsolete versions received on or after 4/9/10 will be returned to the site for transcription. Please notify your joint center institutions and affiliates who are not on e-mail. This form is currently available for web data submission Web-based data submission is mandatory for all forms that are available for web-entry. 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 that is 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. DATE: March 3, 2010 SUBJECT: Web Data Submission Update - RTOG 0537 RTOG # 0537 A Phase II/III Study Comparing Acupuncture-like Transcutaneous Electrical Nerve Stimulation (ALTENS) Versus Pilocarpine in Treating Early Radiation-Induced Xerostomia Web-Based Electronic Data Submission is now available for the following forms: HP-UWHNSS QF-XeQOLS 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 e-mail 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 3/12/10 will be returned to the site for web submission. Please notify your joint center institutions and affiliates who are not on e-mail. Roseann Bonanni, CCRP RTOG Data Management DATE: March 3, 2010 SUBJECT: Web Data Submission Update - RTOG 0724 RTOG 0724 Phase III Study of Concurrent Chemo and Pelvic Radiation therapy in Early-Stage Cervical Carcinoma Web-Based Electronic Data Submission is now available for the following form: QL - Quality of Life 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 e-mail 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. Deb Grant, RN RTOG Data Management DATE: March 1, 2010 SUBJECT: RTOG 0436 FEBRUARY NEWSLETTER Hello: Attached please find the 0436 Newsletter for the month of February. Regards, Treena - RTOG 0436 Newsletter FEBRUARY 2010.pdf DATE: February 26, 2010 SUBJECT: RTOG 0831 - Temporarily Closed, Effective Immediately RTOG 0831: A RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED PHASE III TRIAL TO EVALUATE THE EFFECTIVENESS OF A PHOSPHODIESTERASE 5 INHIBITOR, TADALAFIL, IN PREVENTION OF ERECTILE DYSFUNCTION IN PATIENTS TREATED WITH RADIOTHERAPY FOR PROSTATE CANCER [Prevention of Erectile Dysfunction Study (PEDS)] is closed to patient accrual effective immediately due to problems with drug distribution. We will re-open the study as soon as this issue has been resolved and a new broadcast message will be sent. Please notify your affiliates who are not on e-mail. DATE: February 26, 2010 SUBJECT: RTOG 0837/ACRIN 6689, Activated Activated RTOG 0837/ACRIN 6689, "Randomized, Phase II, Double-Blind, Placebo-Controlled Trial of Conventional Chemoradiation and Adjuvant Temozolomide Plus Cediranib Versus Conventional Chemoradiation and Adjuvant Temozolomide Plus Placebo 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/protocols/0837/0837.pdf Forms for this study can be accessed on the RTOG web site at http://www.rtog.org/members/forms/0837/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/0837/summary_changes.html ACRIN 6689 Imaging Sub-study ACRIN is pleased to collaborate with RTOG 0837 investigators to enroll a subset of 51 trial participants in an imaging sub-study that will evaluate FLT PET and advanced MRI techniques. The primary aim is the identification of imaging biomarkers that are expected to provide valuable information about patient response to treatment, time to progression and survival. Many of these imaging techniques have shown promise in single institution studies and the ACRIN 6689 study will be a significant step forward in their validation. Another prime interest of the imaging sub-study is acquiring information to better understand cediranib's various mechanisms of action in combination therapy with temozolomide and radiation therapy in treating glioblastomas. Brief Four-Question Survey ACRIN is seeking approximately ten sites that will open the RTOG 0837 treatment trial and also carry out the ACRIN 6689 imaging study. If your site would like to be considered for this opportunity, please take a few minutes to complete a four-question survey regarding the level of site interest and the site imaging investigators for ACRIN to contact. http://www.surveymonkey.com/s/8VMLZHF Please notify your affiliates that are not on e-mail. DATE: February 26, 2010 SUBJECT: RTOG Registration Desk Opening 2 Hours Late Today 2/26/2010 Due to inclement weather the RTOG Registration Desk and offices at the American College of Radiology Clinical Research Center will be opening 2 hours late today, 2/26/2010, at 10:30 AM. Web registration for RTOG studies is open and functioning as usual. Thank you for your patience. DATE: February 25, 2010 SUBJECT: RTOG 0539 February 2010 Newsletter Attached is the February issue of the newsletter for RTOG 0539, "Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas." Highlights include: Thoughts From the Chair Allowance for Target Dose Increase Enrollment Information - 0539 February 2010 Newsletter.pdf DATE: February 22, 2010 SUBJECT: Form Revision Notice - RTOG -0921 RTOG 0921 "A PHASE II STUDY OF POSTOPERATIVE INTENSITY MODULATED RADIATION THERAPY (IMRT) WITH CONCURRENT CISPLATIN AND BEVACIZUMAB FOLLOWED BY CARBOPLATIN AND PACLITAXEL FOR PATIENTS WITH ENDOMETRIAL CANCER" 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=0921/0921F1.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    F1a     02/22/2010   Discard obsolete versions and commence use of the revised editions immediately. This form is currently available for web data submission Web-based data submission is mandatory for all forms that are available for web-entry. 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 that is 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. Deb Grant, RN MSN RTOG Data Management DATE: February 18, 2010 SUBJECT: Web-Data Submission Update & Form Revision Notice - RTOG 0831 RTOG # 0831 Phase III Trial to Evaluate the Effectiveness of a Phosphodiesterase 5 Inhibitor, Tadalafil, in Prevention of Erectile Dysfunction in Patients Treated With Radiotherapy for Prostate Cancer Web-Based Electronic Data Submission is now available for the following forms: QF-IIEF (patient) PF-LMAT (patient) PQ-LMAT (spouse/partner) 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 e-mail 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 2/26/10 will be returned to the site for web submission. The PF 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=0831/0831%20PF.pdf The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date PF-LMAT (patient)    PFa     02/15/2010   Changes Made: Element number added for #4 in the code table for Q#3 on the cover page. Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions received after 2/26/10 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: February 18, 2010 SUBJECT: RTOG 0825 JAN/FEB 2010 NEWSLETTER Hello: Attached please find the 0825 Newsletter for the months of January and February. - RTOG 0825 Newsletter JAN & FEB 2010.pdf Regards, Treena DATE: February 18, 2010 SUBJECT: RTOG 0813, Amended Amended 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”, Amendment 1: Correction in Section 3.0 and clarification in Appendix II. Please see the complete Summary of Changes at http://www.rtog.org/members/protocols/0813/summary_changes.html You may download a copy of the protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/protocols/0813/0813.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. If the 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. Sites must submit IRB approval for the amendment to CTSU. Please notify your affiliates that are not on e-mail. DATE: February 16, 2010 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 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=0534/0534qf.pdf The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date QF EQ-5D    QFa     02/15/2010   Changes Made: correction to the code table in Q#1 from the end of RT to week 6 of RT Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions received after February 26, 2010 will be returned to the site for transcription. Please notify your joint center institutions and affiliates who are not on e-mail. Roseann Bonanni, CTR, CCRP RTOG Data Management DATE: February 12, 2010 SUBJECT: RTOG eNews: Jeffrey D. Bradley, MD, New RTOG Lung Cancer Committee Chair www.rtog.org RTOG eNews February 12, 2010 Jeffrey D. Bradley, MD, New RTOG Lung Cancer Committee Chair Jeffrey D. Bradley, M.D., of Washington University School of Medicine in St. Louis, has been appointed Chair of the RTOG Lung Cancer Committee. Dr. Bradley is the S. Lee Kling Associate Professor of Radiation Oncology at the university where he is also the Chief of Thoracic Service and Director of the S. Lee Kling Center for Proton Therapy. “Dr. Bradley is widely recognized as a leader in testing new therapies for lung cancer. He has been actively involved in RTOG research for a number of years and is currently the principal investigator of RTOG’s large phase III trial testing both high-dose conformal radiation therapy and a targeted agent for patients with locally advanced lung cancer,” said Walter J. Curran, Jr., M.D., the RTOG Group Chair. “In 2008 RTOG identified Dr. Bradley as one of our outstanding Next Generation Investigators and his appointment to a group leadership position shows the fulfillment of this early promise.” “The RTOG Lung Cancer Committee has a history of practice-changing innovative research and I am honored to be appointed its new chair,” said Dr. Bradley. “RTOG investigators are examining novel methods of radiation therapy delivery in clinical trials for stereotactic body radiotherapy for both operable and inoperable lung cancer patients as well as testing of the integration of new systemic therapies with optimized radiation. We hope the results of these trials will help to improve the outcomes of cancer patients.” As the chair of the RTOG Lung Cancer Committee, Dr. Bradley will serve on the RTOG Research Strategy Committee and work closely with investigators from the group’s scientific core committees for translational research, advanced technology, symptom management, pathology, medical oncology, surgery, and pathology to develop and report on protocols designed to improve the outcome and quality of life of lung cancer patients. Dr. Bradley succeeds Hak Choy, M.D., the Nancy B. and Jake L. Hamon Distinguished Chair in Therapeutic Oncology Research at the University of Texas Southwestern Medical Center, as RTOG Lung Cancer Committee chair. According to Dr. Curran, “We are very appreciative of Dr. Choy’s leadership of our lung cancer research for the last nine years. Dr. Choy successfully led the Lung Cancer Committee through two competitive grant renewal processes and solidified RTOG as a world leader in performing multicenter cooperative group trials examining advanced radiation therapy technology applications in lung cancer. We are fortunate that he will continue as an active member of the committee.” DATE: February 10, 2010 SUBJECT: RTOG Registration Desk Closure Thursday February 11, 2010 Due to the inclement weather conditions, the RTOG Registration Desk at the American College of Radiology Clinical Research Center will be closed tomorrow, Thursday, February 11, 2010. Institutions can access web registration 24 hours a day, 7 days a week; see information and instructions at https://silver1.phila.acr.org/Clinical_RTOG/pgindex.html Please notify your affiliates that are not on e-mail. DATE: February 09, 2010 SUBJECT: RTOG Registration Desk Closure - Feb 10th Due to the potential severe weather conditions, the RTOG Registration Desk will be closed tomorrow, Wednesday, February 10, 2010. Institutions can access web registration 24 hours a day, 7 days a week; see information and instructions at https://silver1.phila.acr.org/Clinical_RTOG/pgindex.html Please notify your affiliates that are not on e-mail. DATE: February 04, 2010 SUBJECT: RTOG 9813 PROTOCOL NOTICE: NEW Temozolomide Investigator Brochure now available on the website A NEW Investigator Brochure for Temozolomide Version: December 2009 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 04, 2010 SUBJECT: RTOG 0712, Amended Amended 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" Amendment 1: The rectal dose constraints were revised to lower the radiation DVH of the rectum while maintaining all of the required tumor doses. Amendment 2: The dose constraint for the femoral heads was revised to be able to consistently meet the more stringent rectal dose constraint. Please see the complete summary of changes for both amendments at http://www.rtog.org/members/protocols/0712/summary_changes.html Sites can download a copy of the protocol (including Amendments 1 and 2) for IRB review 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 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 the 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. Sites must submit IRB approval for the amendment to CTSU. 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: February 04, 2010 SUBJECT: RTOG 0630, Amended and Cohort A Closure Amended and Cohort A Closure RTOG 0630, "A Phase II Trial of Image Guided Preoperative Radiotherapy for Primary Soft Tissue Sarcomas of the Extremity": Amendment 4: Due to the slow accrual for Cohort A (patients receiving chemotherapy and radiation), this cohort was closed. In addition, the sample size of Cohort B (patients receiving radiation alone) was increased. Please see the complete Summary of Changes at http://www.rtog.org/members/protocols/0630/summary_changes.html Cohort A will be closed at 5 p.m. EST, today, February 4th(a notice of closure of this cohort was previously broadcast on 1/21/10). NOTE: Cohort B of the study will remain open to patient accrual. You may download a copy of the protocol for IRB review 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. If the 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. Sites must submit IRB approval for the amendment to CTSU. 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: January 29, 2010 SUBJECT: RTOG 0617 JANUARY NEWSLETTER Hello: Attached please find the 0617 Newsletter for the month of January. RTOG_0617_Newsletter_January_2010.pdf Regards, Treena DATE: January 29, 2010 SUBJECT: RTOG (0411),(0417),(0615), (0625), 0825 & 0921 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" RTOG 0921, "A PHASE II STUDY OF POSTOPERATIVE INTENSITY MODULATED RADIATION THERAPY (IMRT) WITH CONCURRENT CISPLATIN AND BEVACIZUMAB FOLLOWED BY CARBOPLATIN AND PACLITAXEL FOR PATIENTS WITH ENDOMETRIAL 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. 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. Bevacizumab, AE-1070874, Protocol CALGB-90601, -ISR.PDF DATE: January 29, 2010 SUBJECT: New Quality of Life Consent Withdrawal Form (CQ) Quality of Life Consent Withdrawal (CQ) RTOG has created a Quality of Life (QoL) consent withdrawal form (CQ). If a patient chooses to no longer participate in the quality of life portion of a protocol, this form will need to be completed and signed by both the patient and the institutional PI. After this form is received at RTOG Headquarters, quality of life forms that are due (per the patient's calendar) subsequent to the date the QoL Consent Withdrawal form (CQ) is signed will be suppressed. The CQ form and instructions for the quality of life consent withdrawal are available at http://www.rtog.org/members/forms/list.html. 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.phila.acr.org/ClinicalRtog/faces/jsp/index.jsp DATE: January 28, 2010 SUBJECT: RTOG 0539 January Newsletter Attached is the January issue of the newsletter for RTOG 0539, “Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas.” Highlights include: Kick-off breakfast thank you Recruitment material reminder Special thank you to Arizona Oncology Services Foundation Enrollment information 0539 January 2010 Newsletter.pdf DATE: January 27, 2010 SUBJECT: Guidelines for Completing the RTOG 0825 Treatment Summary Form Guidelines for completing the 0825 Treatment Summary form Question #6 Agent treatment being reported 1 Concurrent RT and TMZ ~ report the 1st 3 weeks of concurrent treatment 2 Concurrent RT, TMZ and Bev/placebo ~ report the LAST 3weeks of the concurrent treatment, this includes the Bev/placebo dose given 2 weeks from the end of RT 3 Adjuvant TMZ and Bev/placebo ~ report each 28 day cycle of adjuvant treatment (1 cycle per TF) Please call Barbara Kaiser R.N. @215-574-3221 with questions Web registration is available 24/7. Information and instructions available at https://clinicalweb1.phila.acr.org/ClinicalRtog/faces/jsp/index.jsp DATE: January 27, 2010 SUBJECT: RTOG 0436 JANUARY NEWSLETTER Hello: Attached please find the 0436 Newsletter for the month of January. RTOG_0436_Newsletter_January_2010.pdf Regards, Treena DATE: January 27, 2010 SUBJECT: RTOG 0433/NCIC CTG SC.20 -- Submission of forms and query replies Investigators participating in RTOG 0433/NCIC CTG SC.20, "A Phase III International Randomized Trial Of Single Versus Multiple Fractions For Re-Irradiation Of Painful Bone Metastases", (an NCIC CTG coordinated study): NCIC CTG has requested that RTOG forward the attached form submission and query letter reply memo. SC20_data_and_query_submission_memo_2010Jan25.pdf Questions concerning this memo should be directed to Carolyn Wilson, the NCIC CTG Study Coordinator, at 613-533-6430, Cwilson@ctg.queensu.ca Please notify your affiliates that are not on e-mail. DATE: January 26, 2010 SUBJECT: Form Revision Notice - RTOG 0724 RTOG 0724 Phase III Study of Concurrent Chemo and Pelvic Radiation therapy in Early-Stage Cervical Carcinoma Forms 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=0724/0724I1.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     01-26-10   This form is currently available for web data submission Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions received after February 1, 2010 will be returned to the site for transcription. Please notify your joint center institutions and affiliates who are not on e-mail. Wendy Bergantz, RN RTOG Data Management DATE: January 26, 2010 SUBJECT: RTOG 94-15/INT 0146/NCCTG 93-46-53: No further patient follow up required RTOG Institutions and investigators participating in RTOG 94-15/INT 0146/NCCTG 93-46-53, "A Phase III Prospective Randomized Trial Comparing Laparoscopic-Assisted Colectomy Versus Open Colectomy for Colon Cancer" (an intergroup study coordinated by the NCCTG): RTOG recently received the following notice of status change from the NCCTG, which was effective 11/27/09: "Per the study design, you may cease follow up for all patients (see Section 18.0). According to regulatory requirements, it is no longer necessary to maintain the paper records; however, local institutional policy must be followed regarding record retention. Please retain this notice with the protocol". Please inform your affiliates that not on e-mail. DATE: January 22, 2010 SUBJECT: RTOG (0411),(0417),(0615), (0625), 0825 & 0921 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" RTOG 0921, "A PHASE II STUDY OF POSTOPERATIVE INTENSITY MODULATED RADIATION THERAPY (IMRT) WITH CONCURRENT CISPLATIN AND BEVACIZUMAB FOLLOWED BY CARBOPLATIN AND PACLITAXEL FOR PATIENTS WITH ENDOMETRIAL 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. - Bevacizumab, AE-1901777, 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 DATE: January 22, 2010 SUBJECT: RTOG (0320) & 0848 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" RTOG 0848 "A PHASE III TRIAL EVALUATING BOTH ERLOTINIB AND CHEMORADIATION AS ADJUVANT TREATMENT FOR PATIENTS WITH RESECTED HEAD OF PANCREAS ADENOCARCINOMA " 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-1727021, Protocol S0727. -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: January 21, 2010 SUBJECT: RTOG 0630, Cohort A Closure Closure Notice Cohort A (patients receiving chemotherapy and radiation) of RTOG 0630, "A Phase II Trial of Image Guided Preoperative Radiotherapy for Primary Soft Tissue Sarcomas of the Extremity", will be closed at 5 p.m. EST, Thursday, February 4th, due to slow accrual. NOTE: Cohort B (patients receiving radiation alone) of the study will remain open to patient accrual. An amendment of the study also will be broadcast on February 4th. Please notify your affiliates who are not on e-mail. DATE: January 21, 2010 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0415 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 forms: FA-Expanded Prostate Cancer Index Composite (EPIC) SA-Utilization of Sexual Medication/Devices HP-Hopkins Symptom Checklist (HSCL-25) 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 e-mail 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 February 5, 2010 will be returned to the site for web submission. PLEASE NOTE: THE QF (EQ-5D) FOR THIS STUDY WILL REMAIN AS A FORM THAT IS SUBMITTED ON PAPER AND WILL NOT BE AVAILABLE FOR WEB SUBMISSION. Please notify your joint center institutions and affiliates who are not on e-mail. Elaine Motyka-Welsh, RN, MSN, CCRP RTOG Data Management DATE: January 21, 2010 SUBJECT: RTOG 0920: Important information regarding the HCO3 assessment Sites and Investigators participating in RTOG 0920, " A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally-Advanced Resected Head and Neck Cancer": In Section 4.1.1 of the protocol, assessment of HCO3 is required within 2 weeks prior to the start of treatment. A venous CO2 is an acceptable equivalent to an arterial draw for this assessment. This information applies immediately to RTOG 0920, and the protocol will be revised in a future amendment. Please notify your affiliates that are not on e-mail. DATE: January 20, 2010 SUBJECT: Form Revision Notice & Web Data Submission Update - 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 Web-Based Electronic Data Submission is now available for the following forms: FA-Expanded Prostate Cancer Index Composite (EPIC) PQ-AUA Symptom Score HP-HSCL-25 SA-Utilization of Sexual Medications/Devices CS-Neurocognitive Evaluation Summary 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 e-mail 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 1/29/10 will be returned to the site for web submission. The CS 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=0534/0534cs.pdf The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date CS    CSa     01/20/10   Changes Made: Last # correctly reached added to Trail Making Test results for Test A and Test B Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions received after 1/29/10 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 20, 2010 SUBJECT:Scheduled Electrical shut down at RTOG Headquarters RTOG Institutions and Investigators Due to a scheduled electrical shut down at RTOG Headquarters, there will no access to the RTOG web site, web registration, or web data entry from 6:30 p.m. EST Friday, January 22nd until 6:00 p.m. EST Saturday, January 23rd. We apologize for any inconvenience. DATE: January 15, 2010 SUBJECT:RTOG eNews: Tampa Update - CME Credits & Webinars CME Credits for Semiannual Meeting Sessions The American College of Radiology (ACR) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. ACR designates this educational activity (RTOG Semiannual Meeting) for a maximum of 15 AMA PRA Category1 CreditsTM. Physicians should only claim credit commensurate with the extent of their participation in the activity. Sign Up for RTOG Meeting Webinars Webinars of the Research Associates Scientific Session and the Health Science Research & Outcomes Committee Meeting will be available for RTOG members unable to travel to Tampa. Research Associates Scientific Session, Friday, January 15, 1:00 - 3:00 PM ET HSRO & Symptom Management Committee Session, Saturday, January 16, 10:00 AM - Noon ET To participate in the webinars you must register ahead of time at http://www.signup4.net/public/ap.aspx?EID=RTOG10E&OID=130. After you register you will be sent a confirmation e-mail with instructions on how to log in to the session(s). It is also recommended that you run the diagnostic test at this time to ensure you have the correct software to participate in the Webinar. Meeting Materials The RTOG Meeting Book, an updated meeting agenda, and other materials for the RTOG Semiannual Meeting at the Tampa Marriott Waterside Hotel January 14 - 17, 2010 are available on the RTOG Web site at 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'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: January 14, 2010 SUBJECT:RTOG eNews: Live from Tampa - RTOG Webinars Sign Up for RTOG Meeting Webinars Webinars of the Research Associates Scientific Session and the Health Science Research & Outcomes Committee Meeting will be available for RTOG members unable to travel to Tampa. Research Associates Scientific Session, Friday, January 16, 1:00 - 3:00 PM ET HSRO & Symptom Management Committee Session, Saturday, January 17, 10:00 AM - Noon ET To participate in the webinars you must register ahead of time at http://www.signup4.net/public/ap.aspx?EID=RTOG10E&OID=130. After you register you will be sent a confirmation e-mail with instructions on how to log in to the session(s). It is also recommended that you run the diagnostic test at this time to ensure you have the correct software to participate in the Webinar. Meeting Materials The RTOG Meeting Book, an updated meeting agenda, and other materials for the RTOG Semiannual Meeting at the Tampa Marriott Waterside Hotel January 14 - 17, 2010 are available on the RTOG Web site at 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'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: January 14, 2010 SUBJECT:RTOG 0920, Important Information about Submission of Tissue Important information from the RTOG Biospecimen Resource for institutions participating in RTOG 0920, " A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally-Advanced Resected Head and Neck Cancer": Testing for EGFR expression (all cases) and HPV (only oropharyngeal cancers) will be performed prior to patient stratification and randomization. Seven to ten days are required for testing. Institutions that are unable to submit a tissue block may instead submit to the RTOG Biospecimen Resource (BSR) FIVE unstained sections mounted onto adherent microscope slides. Send the unstained slides by overnight courier to the BSR. It also is recommended that sites obtain one to three 3 mm core punches of the block to be re-imbedded into a recipient paraffin block (this can be done at the site's pathology department or by the BSR) Institutions can request an FFPE specimen plug kit from the RTOG BSR free of charge for this purpose: 415-476-RTOG (7864)/FAX 415-476-5271; RTOG@ucsf.edu. Additional molecular analyses will be performed on tumor specimens at the end of this trial requiring the submission of further unstained slides at a later date if no plugs or block are submitted. Alternatively institutions may do the following: If it is not feasible for an institution to obtain the unstained sections and punches, and the institution prefers to retain the tissue block, the institution can send the entire paraffin block to the BSR. Unstained sections and the core punches from the block will be made, and the block returned to the site. Please indicate this request on the submission form. This information applies immediately to RTOG 0920. It will be added to the 0920 protocol and any other applicable protocols in future amendments. DATE: January 14, 2010 SUBJECT:RTOG Registration Desk Closure The RTOG Registration Desk will be closed for the Martin Luther King holiday on Monday, January 18th. The Registration Desk will reopen on Tuesday, January 19th at 8:30 a.m. EST. Institutions can access web registration 24 hours a day, 7 days a week; see information and instructions at https://silver1.phila.acr.org/Clinical_RTOG/pgindex.html Please notify your affiliates that are not on e-mail. DATE: January 14, 2010 SUBJECT: Instructions for Consent Withdrawal Form Revised Consent Withdrawal Instructions The instructions for the CW form have been revised. The revised instructions may be found at http://www.rtog.org/pdf_forms.html?members/forms=discontinuation_instructions.pdf 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.phila.acr.org/ClinicalRtog/faces/jsp/index.jsp DATE: January 12, 2010 SUBJECT: Reminder: RTOG 0539 breakfast discussion at RTOG semi-annual meeting Reminder: Please see the attached invitation for a breakfast discussion during the upcoming RTOG Semi-Annual Meeting for RTOG 0539, "Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas IMPORTANT: The discussion will take place in Grand Salon E, not the Florida Foyer as published in the final agenda to be distributed at the RTOG Meeting. Date: Friday, January 15, 2010 Time: 7:00-8:30 am Place: Grand Salon E, Tampa Marriott Waterside Hotel - RTOG 0539 Invitation.pdf DATE: January 8, 2010 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. 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. - Pertuzumab Trastuzmab Investigator Notification Genentech Manufacturer Report 667324, December 22, 2009.pdf DATE: January 8, 2010 SUBJECT: RTOG (0411),(0417),(0615), (0625), 0825 & 0921 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" RTOG 0921, "A PHASE II STUDY OF POSTOPERATIVE INTENSITY MODULATED RADIATION THERAPY (IMRT) WITH CONCURRENT CISPLATIN AND BEVACIZUMAB FOLLOWED BY CARBOPLATIN AND PACLITAXEL FOR PATIENTS WITH ENDOMETRIAL 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. - Bevacizumab, AE-1279067, Protocol AEWS0521, -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 8, 2010 SUBJECT: RTOG (0411),(0417),(0615), (0625), 0825 & 0921 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" RTOG 0921, "A PHASE II STUDY OF POSTOPERATIVE INTENSITY MODULATED RADIATION THERAPY (IMRT) WITH CONCURRENT CISPLATIN AND BEVACIZUMAB FOLLOWED BY CARBOPLATIN AND PACLITAXEL FOR PATIENTS WITH ENDOMETRIAL 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. - Bevacizumab,AE-1858857, Protocol E1305, -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 <<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 8, 2010 SUBJECT: RTOG eNews: RTOG Meeting News RTOG eNews January 8, 2010 New for January 2010 Meeting in Tampa Box lunches will be available for all attendees on Friday and Saturday, January 16 & 17. All are invited to pick up a box lunch in the Salon Foyer and bring it to your session. Webinars of the Research Associates Scientific Session and the Health Science Research & Outcomes Committee Meeting will be available for RTOG members unable to travel to Tampa. See details below. CME credits are available for disease site and scientific committee attendance as well as for the RTOG Symposium, the Scientific Session and the Plenary Session. See the new meeting agenda posting on the RTOG Web site (www.rtog.org/meeting/January_2010_Agenda.pdf) for a list of the sessions awarded credit. Oncology Nursing Society credits (2.0 contact hours) have been awarded for the RA Panel Presentation entitled "Optimizing Radiation-Based Clinical Trials for Quality Patient Care" which will be held on Thursday, January 14 from 3:00 - 5:00 PM. RTOG Symposium - Friday, January 15, 2010 - 9:00 AM - Noon Moving Away from Survival - Novel Clinical Trial Endpoints for Radiation Oncology Research Moderators Terence Z. Wong MD, PhD, Duke University Medical Center James Dignam, PhD, RTOG Group Statistician, University of Chicago Introduction - Surrogate Endpoints James Dignam, PhD, RTOG Group Statistician, University of Chicago New Response Measurements for Malignant Gliomas Michael Vogelbaum, MD, Cleveland Clinic Foundation Non-Survival Endpoints in Head and Neck Trials Qiang Zhang, PhD, RTOG Statistical Center The New Patient Reported Outcomes - Common Toxicity Criteria for Adverse Events (PRO-CTCAE) Reporting System Deborah Watkins Bruner, PhD, University of Pennsylvania Use of Functional Imaging in Evaluating Response in Lung Cancer Trials Mitchell Machtay, MD, Case Western Reserve University School of Medicine Five Years Later - The Phoenix Definition Revisited Daniel A. Hamstra, MD, PhD, The University of Michigan Medical Center Panel Discussion & Summary Scientific & Plenary Sessions - Saturday, January 16, 2010 - 1:00 - 3:00 PM 1:00 PM Scientific Session Christopher Jones, MD, Radiological Associates of Sacramento Short-term Endocrine Therapy Prior to and During Radiation Therapy Improves Overall Survival in Patients with T1b-T2b Adenocarcinoma of the Prostate and PSA ?20: Initial Results of RTOG 94-08 McGowan DG, Hunt D, Jones C, Amin M, Leibenhaut MH, Husain SM, Souhami L, Sandler H, Shipley WU Alexander Sun, MD, Princess Margaret Hospital Phase III Study of Prophylactic Cranial Irradiation (PCI) versus Observation in Patients with Stage III Non-Small Cell Lung Cancer (NSCLC): Neurocognitive and Quality of Life (QOL) Analysis of RTOG 0214 Movsas B, Bae K, Meyers C, Gore E, Bonner J, Sun Alex, Schild S, Gaspar LE, Bogart J, Choy H K. Kian Ang, MD, PhD, University of Texas, MD Anderson Cancer Center A Phase III Trial to Test Accelerated versus Standard Fractionation in Combination with Concurrent Cisplatin for Head and Neck Carcinomas (RTOG 0129): Report of Efficacy and Toxicity Ang K, Pajak T, Wheeler R, Rosenthal D, Nguyen F, Lu C, Kim H, Axelrod R, Silverman C, Weber R Discussant - Mitchell Machtay, MD, Case Western Reserve University School of Medicine Robert Timmerman, MD, University of Texas Southwestern Medical School RTOG 0236: Stereotactic Body Radiation Therapy to Treat Medically Inoperable Early Stage Lung Cancer Patients Timmerman R, Paulus R, Galvin J, Michalski J, Straube W, Bradley J, Fakiris A, Bezjak A, Videtic G, Choy H 2:00 PM Plenary Session Keynote Address - Clinical Radiation Research: Challenges and Opportunities Søren Bentzen, PhD, DSc, University of Wisconsin School of Medicine & Public Health RTOG Group Chair Update Walter J. Curran, Jr., MD, RTOG Group Chair, Emory Winship Cancer Institute Semiannual Meeting Webinars Two semiannual meeting sessions will be broadcast as webinars. Research Associates Scientific Session, Friday, January 16, 1:00 - 3:00 PM ET HSRO & Symptom Management Committee Session, Saturday, January 17, 10:00 AM - Noon ET To participate in the webinars you must register ahead of time at http://www.signup4.net/public/ap.aspx?EID=RTOG10E&OID=130. After you register you will be sent a confirmation e-mail with instructions on how to log in to the session(s). It is also recommended that you run the diagnostic test at this time to ensure you have the correct software to participate in the webinar. Meeting Materials An updated meeting agenda and other materials for the RTOG Semiannual Meeting at the Tampa Marriott Waterside Hotel January 14 - 17, 2010 are available on the RTOG Web site at 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 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: January 7, 2010 SUBJECT: room change: RTOG 0539 breakfast discussion at RTOG semi-annual meeting Please note the room change for this discussion. Please see the attached invitation for a breakfast discussion during the upcoming RTOG Semi-Annual Meeting for RTOG 0539, "Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas" Date: Friday, January 15, 2010 Time: 7:00-8:30 am Place: Grand Salon E, Tampa Marriott Waterside Hotel DATE: January 6, 2010 SUBJECT: RTOG 0539 breakfast discussion at RTOG semi-annual meeting Please see the attached invitation for a breakfast discussion during the upcoming RTOG Semi-Annual Meeting for RTOG 0539, "Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas" Date: Friday, January 15, 2010 Time: 7:00-8:30 am Place: Florida Foyer, Tampa Marriott Waterside Hotel - RTOG 0539 Invitation.pdf DATE: January 5, 2010 SUBJECT: Form Revision Notice - RTOG 0831 RTOG #0831 Phase III Trial to Evaluate the Effectiveness of a Phosphodiesterase 5 Inhibitor, Tadalafil, in Prevention of Erectile Dysfunction in Patients Treated With Radiotherapy for Prostate Cancer Form Revision 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/0831/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 TF    TFa     01/05/10 F1    F1a     01/05/10   Changes Made: TF- Instructions corrected. F1-date of serum testosterone added 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: January 4, 2010 SUBJECT: Request for Data for Upcoming Analysis on RTOG 9111 ALL PARTICPATING INSTITUTIONS IN RTOG 9111 We plan on submitting a manuscript reporting the 10-years results with a focus on overall survival for RTOG 9111. It is critical to have as current as possible follow-up data on every case for the analysis even if it is only the following survival information (Patient status: [dead or alive], status date, cause of death if applicable) Please review your OPS tool and submit all outstanding data through December 31, 2009 to RTOG Headquarters by Friday, February 26, 2010. You can access the OPS tool via the following link: https://silver1.phila.acr.org/Clinical_RTOG/pgSiteTools.html or go to the RTOG homepage 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 this email. Please direct any questions about outstanding data to the Research Associate listed below. Thank you for your cooperation. Joli Lavarino RTOG Data Management 215-574-3154 215-940-8830 (fax) DATE: December 29, 2009 SUBJECT: QF EQ-5D Form for RTOG 0815 RTOG # 0815 A Phase III Prospective Randomized Trial of Dose-Escalated Radiotherapy With or Without Short-Term Androgen Deprivation Therapy for Patients With Intermediate-Risk Prostate Cancer Please note that the QF EQ-5D will not be available for electronic data submission. In order to achieve sufficient quality control of this data, the data must be submitted in paper format only. Please notify your joint center institutions and affiliates who are not on e-mail. Roseann Bonanni, CCRP RTOG Data Management DATE: December 24, 2009 SUBJECT: RTOG 0436 DECEMBER NEWSLETTER Happy Holidays! Attached please find the 0436 Newsletter for the month of December. Regards, Treena - RTOG 0436 Newsletter DECEMBER 2009.pdf DATE: December 24, 2009 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0232 RTOG 0232 A Phase III Study Comparing Combined External Beam Radiation and Transperineal Interstitial Permanent Brachytherapy With Brachytherapy Alone For Selected Patients With Intermediate Risk Prostatic Carcinoma Web-Based Electronic Data Submission is now available for the following form: PQ - AUA Patient Urinary Symptom Questionnaire 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 e-mail 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 January 5, 2010 will be returned to the site for web submission. Please notify your joint center institutions and affiliates who are not on e-mail. Elaine Motyka-Welsh, RN, MSN, CCRP RTOG Data Management DATE: December 24, 2009 SUBJECT: Web-Based Electronic Data Submission Update & Form Revision Notice - RTOG 0815 RTOG # 0815 A Phase III Prospective Randomized Trial of Dose-Escalated Radiotherapy With or Without Short-Term Androgen Deprivation Therapy for Patients With Intermediate-Risk Prostate Cancer Web-Based Electronic Data Submission is now available for the following forms: FA-Expanded Prostate Cancer Index Composite (EPIC) QL-PSQI/GLTEQ HP-PROMIS QF-EQ-5D PLEASE NOTE- IF THE PATIENT COMPLETES THE QF QUESTIONNAIRE, THE ORIGINAL HARD COPY WILL NEED TO BE MAILED TO HEADQUARTERS SO THAT THE BEST IMAGINABLE HEALTH SCALE CAN BE REVIEWED BY THE QOL INVESTIGATOR 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 e-mail 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 December 31, 2009 will be returned to the site for web submission. Form Revision The QF 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=0815/0815%20QF.pdf The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date QF    QFa     12/24/09   Changes Made: Instructions revised. Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions received after 12/31/09 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: December 23, 2009 SUBJECT: Endorsed, GOG-0249 The following study has been endorsed by the Radiation Therapy Oncology Group and its Gynecologic Cancer Working Group: GOG-0249, "A Phase III Trial of Pelvic Radiation Therapy Versus Vaginal Cuff Brachytherapy Followed by Paclitaxel/Carboplatin Chemotherapy in Patients With High Risk, Early Stage Endometrial Carcinoma” RTOG Co-Chair: Catheryn M. Yashar, MD; University of California, San Diego; 858-822-6040; cyashar@ucsd.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 who are not on e-mail. DATE: December 23, 2009 SUBJECT: Endorsed, GOG-0258 The following study has been endorsed by the Radiation Therapy Oncology Group and its Gynecologic Cancer Working Group: GOG-0258, "A Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel vs. Carboplatin and Paclitaxel for Optimally Debulked, Advanced Endometrial Carcinoma" RTOG Co-Chair: I-Chow Joe Hsu, MD; University of California, San Francisco; 415-353-7175; ihsu@radonc.ucsf.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 who are not on e-mail. DATE: December 22, 2009 SUBJECT: Information for the RTOG Semi-Annual Meeting, Tampa FL, January 14 - 17, 2010 The deadline to register for RTOG Meeting Semi-Annual meeting has been moved to January 6, 2010. If you are planning to attend the meeting, please make sure that you register for the meeting, and make your travel reservations in advance. Your preregistration is necessary to ensure that the appropriate amount of resources is devoted to the meeting. You may complete the online registration form for the meeting at the following link: https://registrations.acr.org/rtog/Reg.aspx Registration for the meeting must be received by 4:00pm EST on January 6, 2010 General Information for the meeting, including travel and hotel accommodation can be obtained in the meeting brochure on the RTOG website (www.rtog.org) under the "Meeting" tab. You may also use this http://www.rtog.org/meeting/main.html If you need additional information, please contact Michelle Buado at (215) 574-3224 or via email at mbuado@acr-arrs.org Sincerely yours, Michelle G. Buado DATE: December 18, 2009 SUBJECT: RTOG Biospecimen Resource Holiday Schedule RTOG Biospecimen Resource Holiday Schedule The RTOG Biospecimen Resource will be Closed for the upcoming Holidays: Thursday December 24th- Friday December 25th and Thursday December 31st -Friday January 1st Frozen Biospecimens: To avoid possible delays due to winter weather conditions or customs we ask that sites do NOT ship any frozen biospecimens to us after Wednesday December 16th, but instead wait to ship on Monday January 4th. If sites must ship during the holiday weeks please ONLY ship on Monday Dec 21st , or Monday December 28th. Shipments made Tuesday-Wednesday (22nd -23rd and 29th -30th) cannot be accepted. Canadian Sites- please wait to ship until the New Year. Our recommended Storage Conditions are to store Frozen Biospecimens at -80° C (-70°C to -90°C) until ready to ship. If a -80°C Freezer is not available our alternate storage suggestions include: Samples can be stored short term in a -20° C freezer (non-frost free preferred) for one-two weeks (please ship out Monday) OR: Samples can be stored in plenty of dry ice for one-two weeks, replenishing daily (ship out Monday). OR: Samples can be stored in liquid nitrogen vapor phase (ship out Monday). Kit Requests: We will be accepting Kit Requests until Wednesday Dec 23rd but will not be shipping any kits Monday 28th -Friday January 1st except for emergency situations. Please plan ahead- If you need a kit for the week of the 28th please email us as soon as possible (before 10 am on Wednesday the 23rd) at RTOG@ucsf.edu to ensure you will receive it on time. Happy Holidays and a Happy New Year! DATE: December 17, 2009 SUBJECT: RTOG (0411),(0417),(0615), (0625), 0825 & 0921 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" RTOG 0921, "A PHASE II STUDY OF POSTOPERATIVE INTENSITY MODULATED RADIATION THERAPY (IMRT) WITH CONCURRENT CISPLATIN AND BEVACIZUMAB FOLLOWED BY CARBOPLATIN AND PACLITAXEL FOR PATIENTS WITH ENDOMETRIAL 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. - Bevacizumab Sunitinib Malate, AE-1329500, Protocol 7537, -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 <<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: December 17, 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 (BMS-354825), AE-1263182, Protocol S0325, -FU1.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at https://silver1.phila.acr.org/Clinical_RTOG/pgindex.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: December 17, 2009 SUBJECT: RTOG Registration Desk Early closure tomorrow, 12/18/09 The RTOG Registration Desk will be closed tomorrow, Friday, December 18th from noon-5 p.m. EST. Institutions can access web registration 24 hours a day, 7 days a week; see information and instructions at https://silver1.phila.acr.org/Clinical_RTOG/pgindex.html Also, keep in mind the upcoming holiday closures: Thursday, December 24th, noon-5 p.m. EST, and 8:30 a.m.-5 p.m. EST on Friday, December 25th Thursday, December 31, noon-5 p.m. EST, and 8:30 a.m.-5 p.m. EST on Friday, January 1st On behalf of the RTOG, we would like to wish you all a safe and joyous holiday! Please notify your affiliates that are not on e-mail. DATE: December 17, 2009 SUBJECT: RTOG 0539 December Newsletter Attached is the December issue of the newsletter for RTOG 0539, "Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas." Highlights include information on: Recruitment Material Tampa Kick-Off Breakfast Enrollment - 0539 December Newsletter.pdf DATE: December 16, 2009 SUBJECT: Calendar OPS Tool ATTENTION!! ATTENTION!!! ATTENTION!!! REMINDER ACCESS PATIENT CALENDARS 24/7 - THE OPS TOOL IS IN PRODUCTION 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. This tool has replaced the Forms Due Reports for all RTOG institutions. You can 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 or future dates- you control the date range. Please use this tool on a regular basis to verify that data has been received at headquarters and to also keep informed as to what data is delinquent and needs to be submitted. Attached is the Ops Tool User Guide. If you have general questions, please contact Wendy Bergantz @ (215) 574-3230. For technical support please email websupport@acr-arrs.org - OPS TOOL PPT.ppt DATE: December 16, 2009 SUBJECT: Instructions for Printing Labels ATTENTION!! ATTENTION!! ATTENTION!! PRINTING LABELS You must print your labels using the Print Label function from the Main Menu of the Web Data Submission Tool. Access Data Center Login just as you would to electronically submit data. After you enter your Login and Password scroll to the bottom of the Overdue Forms List and continue to the Main Menu. Click on Print Labels- enter the Study and Case No. and hit submit. The labels will be populated with the patient initials, Study and Case No. and institution number. You need to enter the form type. This utility was optimized to print 1"X 4" labels on sheets with 2 rows of 10 labels. Standard Label is Avery 5161 or equivalent. Data submitted with incomplete labels will be returned to your institution. If you have questions, please contact Wendy Bergantz @ 215-574-3230. DATE: December 15, 2009 SUBJECT: RTOG 0825 NOVEMBER/DECEMBER NEWSLETTER Hello: Attached please find the 825 Newsletter for the months of November and December. Regards, Treena - RTOG 0825 Newsletter NOV DECEMBER 2009.pdf DATE: December 15, 2009 SUBJECT: NSABP B-39/RTOG 0413, Amended Amended 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," has been amended (Amendment 4). For a complete summary of changes see: http://misshare/members/protocols/0413/0413soc.pdff Sites may download a copy of the protocol for IRB review by accessing the RTOG web site at: http://misshare/members/protocols/0413/0413.pdf 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 e-mail mbuado@phila.acr.org. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at - https://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: December 15, 2009 SUBJECT: RTOG (0324), (0234), (0522), 0436, 0617 & 0920 PROTOCOL NOTICE: BMS, ImClone and/or NCI SAFETY REPORTS FOR CETUXIMAB ATTENTION: Imclone recently transitioned the distribution of Expedited Safety Reports (ESRs) to Eli Lilly. Please note the following changes in the method ESRs will be provided: Lilly will not include a cover letter (aka Dear Doctor Letter) Lilly uses the Manufacturer Report Number and date of event instead of the numbering system that Imclone used to track reports Lilly will continue to provide a copy of the subject's MEDWATCH form. Additionally, you will note that there has been a decrease in the number of ESRs generated. According to Lilly, they have a different approach to determining which events need to be reported to Regulators/Investigators. ******************************************************************************************************************************************************** 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"; RTOG 0920 "A PHASE III STUDY OF POSTOPERATIVE RADIATION THERAPY (IMRT) +/- CETUXIMAB FOR LOCALLY-ADVANCED RESECTED HEAD AND NECK 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. Any questions regarding the content of this ESR should be addressed to MG-RD-ESR-Safety-Scientists@bms.com. Kindly include the drug name and ESR number in question in the e-mail header of your query. - erbitux-ib14-esr09-02-18170.pdf - erbitux-ib14-esrDE200911003725.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: December 11, 2009 SUBJECT: Amended and Updated: RTOG 0834 Group-Specific Appendix for United States Sites Amended and Updated: RTOG 0834 Group-Specific Appendix for United States Sites RTOG 0834/EORTC 26053_22054/NCIC CTG CEC.1: Phase III Trial on Concurrent and Adjuvant Temozolomide Chemotherapy in Non-1p/19q Deleted Anaplastic Glioma: The CATNON Intergroup Trial Amendment 1: As mandated by CTEP, the CTCAE version was revised from v. 3.0 to the CTEP Active Version of CTCAE. Additional appendix sections were updated to current standard or corrected for clarity and accuracy. Update: Procedures for specimen submission and certification for neurocognitive testing were updated. United States RTOG sites can download a copy of the summary of changes for the amendment and update as well as the amended, updated Group-Specific Appendix by accessing the CTSU website at - https://www.ctsu.org/ and going to the CTSU members' site (requires CTSU user name and password). 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@phila.acr.org. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at - https://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: December 11, 2009 SUBJECT: RTOG Registration Desk Closure for the holidays: CORRECTION The RTOG Registration Desk will be closed on Monday, December 14th from 1-5 p.m. EST (not 1-4 p.m. as previously broadcast yesterday). We apologize for this error. The RTOG Registration Desk will close as follows for the upcoming holidays: Monday, December 14th, 1-5 p.m. EST Thursday, December 24th, noon-5 p.m. EST, and 8:30 a.m.-5 p.m. EST on Friday, December 25th. Thursday, December 31, noon-5 p.m. EST, and 8:30 a.m.-5 p.m. EST on Friday, January 1st. Institutions can access web registration 24 hours a day, 7 days a week; see information and instructions at https://silver1.phila.acr.org/Clinical_RTOG/pgindex.html Please notify your affiliates that are not on e-mail. DATE: December 10, 2009 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0232 RTOG 0232 A Phase III Study Comparing Combined External Beam Radiation and Transperineal Interstitial Permanent Brachytherapy With Brachytherapy Alone For Selected Patients With Intermediate Risk Prostatic Carcinoma Web-Based Electronic Data Submission is now available for the following forms: FA-Expanded Prostate Cancer Index Composite (EPIC) SA-Utilization of Sexual Medication/Devices 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 e-mail 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 December 18, 2009 will be returned to the site for web submission. Please notify your joint center institutions and affiliates who are not on e-mail. Elaine Motyka-Welsh, RN, MSN, CCRP RTOG Data Management DATE: December 10, 2009 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0848 RTOG #0848 A PHASE III TRIAL EVALUATING BOTH ERLOTINIB AND CHEMORADIATION AS ADJUVANT TREATMENT FOR PATIENTS WITH RESECTED HEAD OF PANCREAS ADENOCARCINOMA Web-Based Electronic Data Submission is now available for the following forms: FA FACIT- Fatigue QOL PR Promis Fatigue Short Form-1 QOL 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 e-mail 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 RTOG Data Management DATE: December 10, 2009 SUBJECT: RTOG Registration Desk Closure for the holidays The RTOG Registration Desk will close as follows for the upcoming holidays: Monday, December 14th, 1-4 p.m. EST Thursday, December 24th, noon-5 p.m. EST, and 8:30 a.m.-5 p.m. EST on Friday, December 25th. Thursday, December 31, noon-5 p.m. EST, and 8:30 a.m.-5 p.m. EST on Friday, January 1st. Institutions can access web registration 24 hours a day, 7 days a week; see information and instructions at https://silver1.phila.acr.org/Clinical_RTOG/pgindex.html Please notify your affiliates that are not on e-mail. DATE: December 9, 2009 SUBJECT: RTOG 0413/NSABP B-39 Article RTOG received the attached article from NSABP regarding 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." The article was published on November 11, 2009, on MedScape's web-site as part of their coverage of the American Society for Radiation Oncology's (ASTRO) 51st Annual Meeting (November 1-5, in Chicago, IL). If you have any further questions regarding this article, please call the NSABP Operations Center at 412-330-4600. Please notify your joint center institutions and affiliates who are not on e-mail. - B-39 Article on Medscape.pdf DATE: December 9, 2009 SUBJECT: Information for the RTOG Semi-Annual Meeting, Tampa FL, January 14 - 17, 2010 Dear RTOG Members: The RTOG Meeting Semi-Annual meeting will be held in Tampa, Florida from January 14 - 17, 2010. The RTOG semi-annual meeting is fast approaching, if you are planning to attend the meeting, please make sure that you register for the meeting, and make your travel reservations in advance. Your preregistration is necessary to ensure that the appropriate amount of resources is devoted to the meeting. You may complete the online registration form for the meeting at the following link: - https://registrations.acr.org/rtog/Reg.aspx Registration for the meeting must be received by 4:00pm EST on Wednesday, December 23, 2009. General Information for the meeting, including travel and hotel accommodation can be obtained in the meeting brochure on the RTOG website (www.rtog.org) under the "Meeting" tab. You may also use this link - http://www.rtog.org/meeting/main.html If you need additional information, please contact Michelle Buado at (215) 574-3224 or via email at mbuado@acr-arrs.org Sincerely yours, Michelle Buado DATE: December 9, 2009 SUBJECT: RTOG 0873, Eligibility Worksheet updated RTOG 0873, "A Phase III Study Of Active Surveillance Therapy Against Radical Treatment In Patients Diagnosed With Favourable Risk Prostate Cancer (START)" Eligibility Worksheet Updated: The Intergroup Patient ID (case #) must be provided (if possible) for non-Canadian patients at the time of randomization (top right corner of the worksheet). The updated worksheet is available on the NCIC CTG website. RTOG 0873 is coordinated by NCIC CTG. Click on the URL below to access the protocol and forms. URL: http://www.ctg.queensu.ca/trials/genito-urinary/pr11/pr11.html User Name: RTOG Password: 4rtog2use For questions about this broadcast, please contact: Andrea Hiltz, M.Sc., Study Coordinator/GU Disease Site Representative Queen's University NCIC Clinical Trials Group 10 Stuart Street Kingston, Ontario K7L 3N6 Canada Telephone: 613.533.6430 Fax: 613.533.2941 E-mail: ahiltz@ctg.queensu.ca DATE: December 8, 2009 SUBJECT: RTOG Biospecimen Resource Holiday Schedule RTOG Biospecimen Resource Holiday Schedule The RTOG Biospecimen Resource will be Closed for the upcoming Holidays: Thursday December 24th- Friday December 25th and Thursday December 31st -Friday January 1st Frozen Biospecimens: To avoid possible delays due to winter weather conditions or customs we ask that sites do NOT ship any frozen biospecimens to us after Wednesday December 16th, but instead wait to ship on Monday January 4th. If sites must ship during the holiday weeks please ONLY ship on Monday Dec. 21st , or Monday December 28th. Shipments made Tuesday-Wednesday (22nd -23rd and 29th -30th) cannot be accepted. Canadian Sites- please wait to ship until the New Year. Our recommended Storage Conditions are to store Frozen Biospecimens at -80° C (-70°C to -90°C) until ready to ship. If a -80°C Freezer is not available our alternate storage suggestions include: -Samples can be stored short term in a -20° C freezer (non-frost free preferred) for one-two weeks (please ship out Monday) OR: -Samples can be stored in plenty of dry ice for one-two weeks, replenishing daily (ship out Monday). OR: -Samples can be stored in liquid nitrogen vapor phase (ship out Monday). Kit Requests: We will be accepting Kit Requests until Wednesday Dec. 23rd but will not be shipping any kits Monday 28th -Friday January 1st except for emergency situations. Please plan ahead- If you need a kit for the week of the 28th please email us as soon as possible (before 10 am on Wednesday the 23rd) at RTOG@ucsf.edu to ensure you will receive it on time. Happy Holidays and a Happy New Year! DATE: December 8, 2009 SUBJECT: Form Revision Notice - RTOG 0921 FORM REVISION NOTICE RTOG 0921 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/0921/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 SF Systemic Treatment Summary Form    SFa     12-8-09 TF Treatment Summary Form    TFa     12-8-09   Changes: SF Form: Q#11(QNO 602-620) Column "C" added. TF Form: Q#11(QNO 602-620) Column "C" added. Discard obsolete versions and commence use of the revised editions immediately. Both forms are currently available for web data submission Web-based data submission is mandatory for all forms that are available for web-entry. 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 that is 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. Deb Grant, RN, MSN RTOG Data Management DATE: December 8, 2009 SUBJECT: RTOG (0411),(0417),(0615), (0625), 0825 & 0921 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" RTOG 0921, "A PHASE II STUDY OF POSTOPERATIVE INTENSITY MODULATED RADIATION THERAPY (IMRT) WITH CONCURRENT CISPLATIN AND BEVACIZUMAB FOLLOWED BY CARBOPLATIN AND PACLITAXEL FOR PATIENTS WITH ENDOMETRIAL 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. - Bevacizumb Sunitib Malate, AE-1939558, Protocol 7537, -ISR.PDF - Bevacizmub, AE-1206408, 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 <<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: December 3, 2009 SUBJECT: Guidelines for Completing the RTOG 0825 Treatment Summary Form Guidelines for completing the 0825 Treatment Summary form Question #6 Agent treatment being reported 1 Concurrent RT and TMZ ~ report the 1st 3 weeks of concurrent treatment 2 Concurrent RT, TMZ and Bev/placebo ~ report the LAST 3weeks of the concurrent treatment, this includes the Bev/placebo dose given 2 weeks from the end of RT 3 Adjuvant TMZ and Bev/placebo ~ report each 28 day cycle of adjuvant treatment (1 cycle per TF) Please call Barbara Kaiser R.N. @215-574-3221 with questions DATE: December 1, 2009 SUBJECT: Upcoming RTOG RA Orientations - 2010 The schedule for the upcoming RTOG RA Orientations is now available on the RA Corner section of the RTOG web site @ http://www.rtog.org/members/RAcorner.html DATE: December 1, 2009 SUBJECT: Data Needed for Upcoming Statistical Analyses for RTOG 9902, 0019 and 0233 ALL INSTITUTIONS PARTICIPATING IN THE FOLLOWING GU STUDIES: RTOG 9902: A PHASE III PROTOCOL OF ANDROGEN SUPPRESSION (AS) AND RADIATION THERAPY (RT) VS AS AND RT FOLLOWED BY CHEMOTHERAPY WITH PACLITAXEL, ESTRAMUSTINE, AND ETOPOSIDE (TEE) FOR LOCALIZED, HIGH-RISK, PROSTATE CANCER RTOG 0019: A PHASE II STUDY OF EXTERNAL BEAM RADIATION THERAPY COMBINED WITH PERMANENT SOURCE BRACHYTHERAPY FOR INTERMEDIATE RISK CLINICALLY LOCALIZED ADENOCARCINOMA OF THE PROSTATE RTOG 0233: A PHASE II RANDOMIZED TRIAL FOR PATIENTS WITH MUSCLE-INVADING BLADDER CANCER EVALUATING TRANSURETHRAL SURGERY AND BID IRRADIATION PLUS EITHER PACLITAXEL AND CISPLATIN OR 5-FLUOROURACIL AND CISPLATIN FOLLOWED BY SELECTIVE BLADDER PRESERVATION AND GEMCITABINE/PACLITAXEL/CISPLATIN ADJUVANT CHEMOTHERAPY Important statistical analyses are upcoming for the following RTOG studies: 9902, 0019 and 0233. Please review your OPS tool and submit all outstanding follow up data due through December 31, 2009 to RTOG Headquarters by January 15, 2010. 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: December 1, 2009 SUBJECT: RTOG 0631, Updated Updated RTOG 0631, "Phase II/III Study of Image-Guided Radiosurgery/SBRT for Localized Spine Metastasis:" The Reimbursement and Confidentiality/Storage sections were renumbered as Sections 10.7.and 10.8, respectively, due to a numbering error in the 11/6/09 amended version. Sites can access the complete summary of changes at http://www.rtog.org/members/protocols/0631/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/0631/0631.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 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. DATE: November 30, 2009 SUBJECT: RTOG 0617 NOVEMBER NEWSLETTER Hello: Attached please find the 0617 Newsletter for the month of November. Regards, Treena - RTOG 0617 Newsletter NOVEMBER 2009.pdf DATE: November 30, 2009 SUBJECT: RTOG 0436 NOVEMBER NEWSLETTER Hello: Attached please find the November newsletter for the 0436 study. Regards, Treena - RTOG 0436 Newsletter NOVEMBER 2009.pdf DATE: November 23, 2009 SUBJECT:RTOG 9813, 0436, 0521, 0525, 0617 & 0834 PROTOCOL NOTICE: Thanksgiving Holiday Shipping Schedule for all study drug products provided through Biologics Biologics Clinical Trial Services is closed for Thanksgiving on Thursday, Nov.26, and Friday, Nov. 27, 2009. They will resume regular business hours on Monday, Nov. 30. If you have questions or need to coordinate shipments in advance, please don't hesitate to contact Karl Buer, the RTOG Clinical Trial Project Manager at 800-693-4906 Ext. 4991 or Kbuer@biologicstoday.com. The study drug products distributed by Biologics include the following: Temozolomide for RTOG 9813, 0525 & 0834 Cetuximab and Paclitaxel for RTOG 0436 & 0617 Taxotere for RTOG 0521 DATE: November 20, 2009 SUBJECT:RTOG (0411),(0417),(0615), (0625), 0825 & 0921 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" RTOG 0921, "A PHASE II STUDY OF POSTOPERATIVE INTENSITY MODULATED RADIATION THERAPY (IMRT) WITH CONCURRENT CISPLATIN AND BEVACIZUMAB FOLLOWED BY CARBOPLATIN AND PACLITAXEL FOR PATIENTS WITH ENDOMETRIAL CANCER" - Bevacizumab & Sunitinib malate, AE-1312527, 1395393, 1474081, 1613977, Protocol 7537, -FU#1.pdf - Bevacizumab, AE-1202538, Protocol GOG-0218, -FU#1.pdf - Bevacizumab, Follow-Up to a Written Report, AE-1823741, Protocol GOG-0218, -FU1.pdf - Bevacizumab, AE-1192440, Protocol CALGB-40502, -FU#1.pdf - Bevacizumab, AE-1843518, Protocol GOG-0218, -FU#3.pdf 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. 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: November 20, 2009 SUBJECT:RTOG Registration Desk Closure for Thanksgiving The RTOG Registration Desk will close for the Thanksgiving holiday on Wednesday, November 25th at noon EST and will remain closed on Thursday and Friday, November 26th and 27th. The Registration Desk will re-open on Monday, November 30th at 8:30 a.m. EST. Institutions can access web registration 24 hours a day, 7 days a week; see information and instructions at https://silver1.phila.acr.org/Clinical_RTOG/pgindex.html Please notify your affiliates that are not on e-mail. DATE: November 19, 2009 SUBJECT:SoCRA Exam at the RTOG Semiannual Meeting In order to finalize the arrangements for the SoCRA exam at the RTOG semiannual meeting in January we need an estimate of the number of our members who plan to register for the exam. If you want to take the SoCRA Certification Exam at the January RTOG meeting in Tampa please send an e-mail to Marianne Yachinsky (MYACHINSKY@ACR-ARRS.ORG) by Tuesday, November 24th. Thank you! 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 available at https://clinicalweb1.phila.acr.org/ClinicalRtog/faces/jsp/index.jsp DATE: November 19, 2009 SUBJECT:Information for the RTOG Semi-Annual Meeting, Tampa FL, January 14 - 17, 2010 November 19, 2009 Dear RTOG Members: The RTOG Meeting Semi-Annual meeting will be held in Tampa, Florida from January 14 - 17, 2010. If you are planning to attend the meeting, please make sure that you register for the meeting, and make your travel reservations in advance.. Your preregistration is necessary to ensure that the appropriate amount of resources is devoted to the meeting. You may complete the online registration form for the meeting at the following link: https://registrations.acr.org/rtog/Reg.aspx Registration for the meeting must be received by 4:00pm EST on Wednesday, December 23, 2009. General Information for the meeting, including travel and hotel accommodation can be obtained in the meeting brochure on the RTOG website (www.rtog.org) under the "Meeting" tab. You may also use this http://www.rtog.org/meeting/main.html If you need additional information, please contact Michelle Buado at (215) 574-3224 or via email at mbuado@acr-arrs.org Sincerely yours, Michelle Buado DATE: November 19, 2009 SUBJECT:RTOG 0631, Amended Amended RTOG 0631, "Phase II/III Study of Image-Guided Radiosurgery/SBRT for Localized Spine Metastasis," Amendment 1: As mandated by CTEP, the CTCAE version referred to in the protocol was revised from v. 3.0 to the CTEP Active Version of CTCAE. Additional sections were updated to current RTOG standard or corrected for clarity and accuracy. Sites can access the complete summary of changes at http://www.rtog.org/members/protocols/0631/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/0631/0631.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. If the 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@phila.acr.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: November 18, 2009 SUBJECT:RTOG 0825 Pseudo Progression It has come to our attention that we will need to capture some additional data on the SR form. An amended SR form will be forthcoming but in the interim we will need to capture if patients during their pre-cycle 1 scan experienced pseudo progression. If the patient has experienced pseudo progression, on the Pre-cycle 1 scan please amend the SR form to reflect this information by adding pseudo progression to the comments section. Please note that per section 11.4 Patients with pseudo progression at this time point are to continue on study. If you have any questions please contact Denise Manfredi RT(T) RTOG RTQA 215-717-2755 And/or Erin J. Cunningham, MHSA RTOG RTOQA 215-717-0831 DATE: November 18, 2009 SUBJECT:RTOG 0539 November Newsletter Attached is the November issue of the newsletter for RTOG 0539, “Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas.” Highlights include: Important Pathology Reminder Information on Recruitment Material & Study Kick-Off Event Enrollment Attachment DATE: November 18, 2009 SUBJECT: RTOG Biospecimen Resource Thanksgiving Holiday Schedule RTOG Biospecimen Resource Thanksgiving Holiday Schedule The RTOG Biospecimen Resource will be closed for the Thanksgiving Holiday Thursday November 26th - Friday November 27th. Frozen Biospecimens: We ask that sites do not ship any frozen biospecimens to us that week if at all possible, instead please wait to ship on Monday November 30th. Shipments made Tuesday (24th) or Wednesday (25th) cannot be accepted. Our recommended Storage Conditions are to store Frozen Biospecimens at -80° C (-70°C to -90°C) until ready to ship. If a -80°C Freezer is not available our alternate storage suggestions include: Samples can be stored short term in a -20° C freezer (non-frost free preferred) for up to one week (please ship out Monday) OR: Samples can be stored in plenty of dry ice for up to one week, replenishing daily (ship out Monday). OR: Samples can be stored in liquid nitrogen vapor phase (ship out Monday). Kit Requests: We will be accepting Kit Requests Monday-Tuesday (23rd and 24th) but will not be shipping any kits on Wednesday 25th -Friday 27th. If you need a kit for November 30th or December 1st please email us at RTOG@ucsf.edu before Monday the 23rd to ensure you will receive it on time. Have a Happy Thanksgiving! DATE: November 17, 2009 SUBJECT: RTOG 0848, Activated RTOG 0848, A Phase III Trial Evaluating Both Erlotinib and Chemoradiation as Adjuvant Treatment for Patients with Resected Head of Pancreas Adenocarcinoma Institutions can download a copy of the protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/protocols/0848/0848.pdf Forms for this study can be accessed on the RTOG web site at http://www.rtog.org/members/forms/0848/main.html Funding Note: Sites will receive an additional $1000 per eligible patient registered, for a total of $3000 per patient. Regulatory Notes: NCI policy requires that the "Version Date" on 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/0848/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. Web registration is available 24/7. Information and instructions available at https://clinicalweb1.phila.acr.org/ClinicalRtog/faces/jsp/index.jsp DATE: November 16, 2009 SUBJECT: RTOG 0831, Activated: CORRECTION RTOG 0831, "A Randomized, Double-Blinded, Placebo-Controlled Phase III Trial To Evaluate The Effectiveness Of A Phosphodiesterase 5 Inhibitor, Tadalafil, In Prevention Of Erectile Dysfunction In Patients Treated With Radiotherapy For Prostate Cancer [Prevention of Erectile Dysfunction Study (PEDS)]" Institutions can download a copy of the protocol for IRB review by accessing the RTOG website at http://www.rtog.org/members/protocols/0831/0831.pdf Forms for this study also are available on the RTOG website at http://www.rtog.org/members/forms/0831/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. 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 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. Web registration is available 24/7. Information and instructions available at https://clinicalweb1.phila.acr.org/ClinicalRtog/faces/jsp/index.jsp DATE: November 16, 2009 SUBJECT:RTOG 0831, Activated RTOG 0831, "A Phase II Protocol For Patients With Stage T1 Bladder Cancer To Evaluate Selective Bladder Preserving Treatment By Radiation Therapy Concurrent With Cisplatin Chemotherapy Following A Thorough Transurethral Surgical Re-Staging [Prevention of Erectile Dysfunction Study (PEDS)]" Institutions can download a copy of the protocol for IRB review by accessing the RTOG website at http://www.rtog.org/members/protocols/0831/0831.pdf Forms for this study also are available on the RTOG website at http://www.rtog.org/members/forms/0831/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. 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 available at https://clinicalweb1.phila.acr.org/ClinicalRtog/faces/jsp/index.jsp DATE: November 13, 2009 SUBJECT: RTOG 0825: Clarification of Scan Time point ATTENTION!!! Please note for clarification this issue will be addressed in a forthcoming protocol update for RTOG 0825. The scan for blood detection must be obtained within 1 week prior to 2nd step registration. 3.1.6.1 An MRI or CT scan (potentially in addition to the postoperative scan) must be obtained within 1 week prior to registration and must not demonstrate significant postoperative hemorrhage defined as > 1 cm diameter of blood. If > 1 cm of acute blood is detected, the patient will be ineligible for this trial. The radiation planning MRI or CT scan may be used to determine presence of hemorrhage DATE: November 13, 2009 SUBJECT: RTOG 0822, Closure Closure 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", will close to patient accrual at 5 PM EST today, November 13, because the study has met its accrual objective. (Notice of this closure was previously broadcast on October 30.) 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: November 12, 2009 SUBJECT: RTOG 0825 Central Pathology Review Form Instructions Attention! 0825 participants Attention! When submitting the P4, central pathology review form, please list the names and contact information for those who need to be copied on the eligibility notification email. Please limit this to no more than 3 persons. You can also include those you want copied on the email notification that you send to Dr. Aldape’s lab at the time you are shipping the tissue. Contact Barbara Kaiser R.N. @215-574-3221 with any questions. DATE: November 11, 2009 SUBJECT: RTOG 0926, Activated Activated RTOG 0926, "A Phase II Protocol For Patients With Stage T1 Bladder Cancer To Evaluate Selective Bladder Preserving Treatment By Radiation Therapy Concurrent With Cisplatin Chemotherapy Following A Thorough Transurethral Surgical Re-Staging" Institutions can download a copy of the protocol for IRB review by accessing the RTOG website at http://www.rtog.org/members/protocols/0926/0926.pdf Forms for this study also are available on the RTOG website at http://www.rtog.org/members/forms/0926/main.html Update: Appendix VI is posted on the RTOG website next to the protocol. This was noted in the protocol on the "Appendix VI" page. 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/0926/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: November 10, 2009 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0915 Web-Based Electronic Data Submission is now available for the following forms RTOG 0915 (NCCTG N0927) A RANDOMIZED PHASE II STUDY COMPARING 2 STEREOTACTIC BODY RADIATION THERAPY (SBRT) SCHEDULES FOR MEDICALLY INOPERABLE PATIENTS WITH STAGE I PERIPHERAL NON-SMALL CELL LUNG CANCER F1 Follow up form T1 Radiotherapy form A5 Demographic 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 DATE: November 6, 2009 SUBJECT: RTOG (0234), (0324), 0436, (0522), 0617, 0920 PROTOCOL NOTICE: NEW Cetuximab Investigator Brochure now available on the website A NEW Investigator Brochure for Cetuximab Version Number: 14 dated 24-August-2009 for RTOG (0324), (0234), (0522), 0436, 0617 & 0920 is now available on the RTOG website at http://www.rtog.org/investbrochure.html. This version replaces the previous Version Number 13 dated 21-August-2008. The Summary of Changes is included within the document beginning on page 3. ****The same username and password currently required to view all confidential materials on the RTOG website must be used to access this Investigator Brochure**** DATE: November 6, 2009 SUBJECT: Form Revision Notice - RTOG 0617 Form Revision 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 The following forms for this study have been revised. Download the new version from the RTOG web site @ http://www.rtog.org/members/forms/0617/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     11-6-09 DP Patient Swallowing Diary    DPa     11-6-09   Changes Made: I1 form: Question 14A - The code table has been expanded to collect additional responses to the question, "Is it malignant", pertaining to the presence of a pleural effusion. DP form: The written instructions to the patient regarding the completion of the swallowing diary have been expanded and clarified. The form questions have not changed. Please Note: The I1 form is available for web data submission. Please notify your joint center institutions and affiliates who are not on e-mail. Mary Gramkowski. RN, BA, CCRP RTOG Research Associate, Lung Team 215-574-3159 DATE: November 6, 2009 SUBJECT: RTOG 0127/ECOG E5597: Documents from ECOG Closed RTOG 0127/ECOG E5597, "Phase III Chemoprevention Trial of Selenium Supplementation in Persons with Resected Stage I Non-Small Cell Lung Cancer", effective November 5, 2009 at 5 p.m. EST. Per the ECOG Coordinating Center: The Eastern Cooperative Oncology Group's Data Monitoring Committee (DMC) reviewed E5597 and determined that the study was not likely to meet its endpoint. Therefore, the DMC recommended the study be closed to new accrual and that the intervention be stopped. All patients should discontinue the selenium/placebo tablets at this time. All patients are to be followed according to the study for recurrence and survival (as instructed in the "After Protocol Therapy" section of the Forms Submission Schedule at http://ecog.dfci.harvard.edu/cgi-bin/forms.cgi). Study investigators have carefully considered how to follow patients and feel it would be most proper and useful to continue to follow patients in a blinded fashion. However, if a patient asks to know which supplement he/she was receiving unblinding may occur. To unblind your patient please visit: https://webapps.ecog.org/UnblindPatTxListing/E5597Tx or log into the ECOG Web Application Portal at https://webapps.ecog.org and find the link for the E5597 patient listings.* * Patients who request to be unblinded will continue to be followed in the manner originally outlined in the protocol. In addition, those patients who agreed to participate in the correlative project are requested to continue to provide blood and sputum samples as described in section 11.2 of the protocol. Samples for selenium blood levels (section 11.1) do NOT need to be submitted. Details regarding the ECOG DMC's action are available on the ECOG website (http://www.ecog.org/ecoginst/E5597.html) and can be used to inform your IRB of this action. A frequently asked questions document has also been posted. In addition, physicians should review this information with their patients. To facilitate this discussion, we have prepared letters that can be distributed to them. These letters are available online at http://www.ecog.org/ecoginst/E5597.html. We encourage you to make this information available to your patients. Please notify your affiliates who are not on e-mail. Some RTOG institutions are having difficulty accessing the documents referred to below in ECOG's closure text for RTOG 0127/ECOG E5597. Therefore, ECOG has provided the documents, which are attached for your use. For any further questions about the closure of this study, RTOG sites should contact Alice Hackman, ECOG Coordinating Center, 617-632-3610, hackman.alice@jimmy.harvard.edu - E5597_Letter_to_Physicians.pdf - E5597_FAQ.PDF - E5597_Letter_to_patients_off_treatment.doc - E5597_Letter_to_patients_on_treatment.doc - e5597formssubmit.pdf DATE: November 6, 2009 SUBJECT: RTOG 0539, Pathology Reminder RTOG 0539, Pathology Reminder When submitting tissue for Central Pathology Review in conjunction with Step 1 Registration, please remember to send one H&E slide per paraffin block, rather than one representative H&E slide. This can be accomplished most efficiently and expeditiously by simply requesting that the histology lab cut 2 sets of slides up front (one for routine diagnosis and the other for central review). Please refer to Section 10.2 of the protocol for Central Pathology Review submission details. Contact Dr. Arie Perry with questions (aperry@wustl.edu; 314-362-7426). DATE: November 6, 2009 SUBJECT: RTOG 0921, Activated Activated: RTOG 0921: "A Phase II Study of Postoperative Intensity Modulated Radiation Therapy (IMRT) with Concurrent Cisplatin and Bevacizumab Followed by Carboplatin and Paclitaxel for Patients with Endometrial Cancer" Institutions can download a copy of the protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/protocols/0921/0921.pdf Forms for this study also are available on the RTOG web site at http://www.rtog.org/members/forms/0921/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/0921/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: November 6, 2009 SUBJECT: Neurocognitive Assessments for RTOG 0424, 0525, 0534, 0614 and 0825 When completing the neurocognitive assessment on your patients, please submit to Headquarters the summary form only. The summary form contains the scores from the evaluations. You are to keep the worksheets in the patient's record for audit purposes. Any worksheets submitted to Headquarters will be returned to the site. The current studies utilizing the neurocognitive assessment are: RTOG#0424 RTOG#0525 RTOG#0534 RTOG#0614 RTOG#0825 Please notify your joint center institutions and affiliates who are not on e-mail. Roseann Bonanni, CTR, CCRP RTOG Data Management DATE: November 6, 2009 SUBJECT: Form Revision Notice - RTOG 0815 RTOG # 0815 A Phase III prospective randomized trial of dose-escalated radiotherapy with or without short-term androgen deprivation therapy for patients with intermediate-risk prostate cancer Form Revision 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/0815/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 FA    FAa     11/06/09 QL    QLa     11/06/09   Changes Made: The FA had internal schema changes The QL-the cover page was omitted at activation. If you have submitted a completed QL form, please complete the cover page for that time point. Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions received after November 13, 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, CTR, CCRP RTOG Data Management DATE: November 6, 2009 SUBJECT: RTOG 0415, Closure Closure 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", will close to patient accrual at 5 PM EST today, November 6, because the study has met its accrual objective. (Notice of this closure was broadcast October 22.) 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: November 6, 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, Follow-Up to a Written Report, AE-1720941, 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: November 5, 2009 SUBJECT: RTOG 0127/ECOG 5597, Closed Closed RTOG 0127/ECOG E5597, "Phase III Chemoprevention Trial of Selenium Supplementation in Persons with Resected Stage I Non-Small Cell Lung Cancer", effective November 5, 2009 at 5 p.m. EST. Per the ECOG Coordinating Center: The Eastern Cooperative Oncology Group's Data Monitoring Committee (DMC) reviewed E5597 and determined that the study was not likely to meet its endpoint. Therefore, the DMC recommended the study be closed to new accrual and that the intervention be stopped. All patients should discontinue the selenium/placebo tablets at this time. All patients are to be followed according to the study for recurrence and survival (as instructed in the "After Protocol Therapy" section of the Forms Submission Schedule at http://ecog.dfci.harvard.edu/cgi-bin/forms.cgi). Study investigators have carefully considered how to follow patients and feel it would be most proper and useful to continue to follow patients in a blinded fashion. However, if a patient asks to know which supplement he/she was receiving unblinding may occur. To unblind your patient please visit: https://webapps.ecog.org/UnblindPatTxListing/E5597Tx or log into the ECOG Web Application Portal at https://webapps.ecog.org and find the link for the E5597 patient listings.* * Patients who request to be unblinded will continue to be followed in the manner originally outlined in the protocol. In addition, those patients who agreed to participate in the correlative project are requested to continue to provide blood and sputum samples as described in section 11.2 of the protocol. Samples for selenium blood levels (section 11.1) do NOT need to be submitted. Details regarding the ECOG DMC's action are available on the ECOG website (http://www.ecog.org/ecoginst/E5597.html) and can be used to inform your IRB of this action. A frequently asked questions document has also been posted. In addition, physicians should review this information with their patients. To facilitate this discussion, we have prepared letters that can be distributed to them. These letters are available online at http://www.ecog.org/ecoginst/E5597.html. We encourage you to make this information available to your patients. Please notify your affiliates who are not on e-mail. DATE: November 5, 2009 SUBJECT: RTOG 0433/NCIC CTG SC.20, Amended RTOG 0433/NCIC CTG SC.20, "A Phase III International Randomized Trial Of Single Versus Multiple Fractions For Re-Irradiation Of Painful Bone Metastases", an NCIC CTG coordinated study, has been amended (Amendment #5). The amended protocol and the summary of changes are located on the NCIC CTG website under "Protocol - Amendment #5 - 2009AUG07" and "Amendment/Update Documentation". Sites can access the protocol documents via the following link: http://www.rtog.org/members/protocols/0433/index.html. A username and password for NCIC CTG website access is provided. The sample consent (Appendix VIII) for use by U.S. RTOG sites is available on the RTOG website at http://www.rtog.org/members/protocols/0433/consent.html. The first paragraph under "What are the Costs" (p. 8) was revised for U.S. institutions. Questions about the protocol should be directed to the NCIC CTG Study Coordinator, Carolyn Wilson, at 613-533-6430, CWilson@ctg.queensu.ca. 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: November 5, 2009 SUBJECT: RTOG 0920, Activated Activated RTOG 0920, "A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally-Advanced Resected Head and Neck Cancer" Institutions can download a copy of the protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/protocols/0920/0920.pdf Forms for this study can be accessed on the RTOG web site at http://www.rtog.org/members/forms/0920/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. 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: November 5, 2009 SUBJECT: Information for the RTOG Semi-Annual Meeting, Tampa FL, January 14 - 17, 2010 Dear RTOG Members: The RTOG Meeting Semi-Annual meeting will be held in Tampa, Florida from January 14 - 17, 2010. If you are planning to attend the meeting, please make sure that you register for the meeting, and make your travel reservations in advance. Your preregistration is necessary to ensure that the appropriate amount of resources is devoted to the meeting. You may complete the online registration form for the meeting at the following link: https://registrations.acr.org/rtog/Reg.aspx Registration for the meeting must be received by 4:00pm EST on Wednesday, December 23, 2009. General Information for the meeting, including travel and hotel accommodation can be obtained in the meeting brochure on the RTOG website (www.rtog.org) under the "Meeting" tab. You may also use this http://www.rtog.org/meeting/main.html If you need additional information, please contact Michelle Buado at (215) 574-3224 or via email at mbuado@acr-arrs.org Sincerely yours, Michelle Buado DATE: November 4, 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-1392926, 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: October 30, 2009 SUBJECT: RTOG 0822, Closure Notice Closure Notice 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", will close to patient accrual at 5 PM EST Friday, November 13, 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: October 30, 2009 SUBJECT: RTOG 0436 OCTOBER NEWSLETTER Hello: Attached please find the 0436 Newsletter for the month of October. Regards, Treena - RTOG 0436 Newsletter OCTOBER 2009.pdf DATE: October 29, 2009 SUBJECT: RTOG 0617/NCCTG N0628/CALGB 30609/ECOG R0617, Amended and Updated Amended and Updated 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 in Patients With Stage IIIA/IIIB Non-Small Cell Lung Cancer", has been amended and updated. Amendment 4: Section 3.1.2 was amended to include patients with a nodal recurrence after surgery for an early stage NSCLC. Update: Sections 10.2.5 and 10.2.5.1 were updated to current RTOG Biospecimen Resource standards. Sites can access the complete Summary of Changes for the amendment and for the update at http://www.rtog.org/members/protocols/0617/summary_changes.html Sites can download a copy of the amended and updated 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. The "Update Date" indicates that editorial/administrative changes were made to the protocol after NCI approved the amendment. NCI requires that these changes be documented on the protocol title page as an update, not as an amendment. For clarity, the broadcast date of the amendment and update is provided in parentheses on each summary of change. Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. If the 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. 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: October 29, 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 3: The title page and Section 10.0 were amended. 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. If the 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/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: October 29, 2009 SUBJECT: RTOG eNews: RTOG ASTRO Presentations RTOG eNews October 29, 2009 RTOG ASTRO Abstracts Features 2 Plenary Session Presentations RTOG investigators will present 24 abstracts at the American Society for Radiation Oncology (ASTRO) 51st Annual Meeting in Chicago, IL, November 1 - 5, 2009. Two RTOG presentations will be featured in the Monday plenary session: Christopher Jones, M.D., will present Short-term Endocrine Therapy Prior to and During Radiation Therapy Improves Overall Survival in Patients with T1b-T2b Adenocarcinoma of the Prostate and PSA ?20: Initial Results of RTOG 94-08, and Benjamin Movsas, M.D., will present Phase III Study of Prophylactic Cranial Irradiation (PCI) versus Observation in Patients with Stage III Non-Small Cell Lung Cancer (NSCLC): Neurocognitive and Quality of Life (QOL) Analysis of RTOG 0214. If you are attending ASTRO please make sure to visit the RTOG booth (#1562). Below is a list of the presentations and attached is a list of the sessions by date and time. A booklet containing all of the RTOG abstracts will be available on the RTOG Web site after the close of the meeting. - RTOG ASTRO 2009 by Date.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: October 27, 2009 SUBJECT: RTOG 0612, Amended Amended RTOG 0612, "Investigating Markers of Radiation Outcome in Patients With Intermediate-Risk Prostate Cancer Using DNA Microarray Analysis: An RTOG Pilot Study" Amendment 1: The Principal Investigator's contact information was updated. Institutions can access the complete summary of changes at http://www.rtog.org/members/protocols/0612/summary_changes.html Institutions can download a copy of the protocol for IRB review at http://www.rtog.org/members/protocols/0612/0612.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. If the 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/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: October 26, 2009 SUBJECT: RTOG 0617 OCTOBER NEWSLETTER Hello: Attached please find the 0617 newsletter for the month of October. - RTOG 0617 Newsletter OCTOBER 2009.pdf Regards, Treena DATE: October 26, 2009 SUBJECT: RTOG 0619, Important Information about Submission of Tissue Important information for institutions participating in 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": Institutions that are unable to submit a tissue block for the required central review (and for patients with oropharyngeal carcinoma, the required HPV analysis) may instead take 3 unstained sections from the block then obtain three 3mm core punches of the block and re-imbed the core punches into a recipient paraffin for submission. Institutions can request an FFPE specimen plug kit from the RTOG Biospecimen Resource free of charge for this purpose: 415-476-RTOG (7864)/FAX 415-476-5271; RTOG@ucsf.edu Or institutions can use the following alternative: If an institution is uncomfortable with obtaining the unstained sections and punches and wants to retain the tissue block, the site can send the entire block to the RTOG Biospecimen Resource, and the Resource will obtain the unstained sections and the core punches from the block and return the remaining block to the site. Please indicate this request (to obtain the sections, perform the core punch procedure, and return the block) on the submission form. Note: For oropharyngeal carcinoma patients, there is a 10-day turnaround needed for HPV assays, so institutions should send the block by overnight courier to the Biospecimen Resource as soon as possible with their request. This information applies immediately to RTOG 0619 and to all applicable RTOG head and neck studies. It will be added to the 0619 protocol and any other applicable protocols in future amendments. Please notify your affiliates that are not on e-mail. DATE: October 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/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. Any questions regarding the content of this ESR should be addressed to MG-RD-ESR-Safety-Scientists@bms.com. Kindly include the drug name and ESR number in question in the e-mail header of your query. - Cetuximab, Investigator Notification, Imclone Systems 09-02-17988 -Merck 6054349, October 8, 2009.pdf - Cetuximab, Follow-Up to an Investigator Notifictaion, Imclone Systems 09-02-1763-Merck 6053727, October 8, 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: October 23, 2009 SUBJECT: RTOG 0517 & 0518 Protocol Notice: Novartis SAFETY REPORT FOR ZOMETA RTOG has received safety report(s) from the Novartis for Zometa The Following RTOG study(s) involve Zometa: RTOG 0518 "A Phase III, Double-blind, Placebo-controlled Study 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" RTOG 0517 "Randomized Phase III Trial to Evaluate Radiopharmaceuticals and Zoledronic Acid in the Palliation of Osteoblastic Metastases from Lung, Breast and Prostate Cancer" Please send the report(s) to your institutional IRB. A copy also should be retained in your protocol file. The safety report(s) do not require revisions to the above protocol at this time. - PHOO2009IL04263 04-09-09.pdf - PHHO2008DE11815 10-13-08.pdf - PHHO2009FR01323 02-04-09.pdf - PHHO2009US01375 02-03-09.pdf - PHOO2008DE14219 06-03-09.pdf - PHHO2007CN20134 12-20-07.pdf - PHHO2008DE14219 01-15-09.pdf - PHHO2009FR01323 02-12-09.pdf - PHHO2009US08904 07-24-09.pdf - PHHO2008BE00726 01-21-08.pdf - PHHO2008NL14392 12-16-08.pdf - PHHO2009FR09265 08-11-09.pdf - PHHO2009US08904 08-03-09.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: October 23, 2009 SUBJECT: RTOG 0537, Closure Phase II Closure The phase II component 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 close to patient accrual at 5:00 PM EST today, Friday, October 23, because this component of the study has met its accrual goal. (Notice of this closure was broadcast on October 19, 2009.) All institutions must ship the Codetron® unit to RTOG Headquarters within 1 week following the final treatment of the last patient entered on study at the institution. Return address labels were included in the initial shipment of the Codetron® unit to individual institutions. If you have questions about returning the Codetron® unit, please call RTOG Headquarters at 215-574-3192. 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@phila.acr.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: October 22, 2009 SUBJECT: RTOG 0621 PROTOCOL NOTICE: US Taxotere Supply RTOG has received information from sanofi-aventis regarding the US Taxotere supply for RTOG 0621 RTOG 0621 "ADJUVANT 3DCRT/IMRT IN COMBINATION WITH ANDROGEN SUPPRESSION AND DOCETAXEL FOR HIGH RISK PROSTATE CANCER PATIENTS POST-PROSTATECTOMY: A PHASE II TRIAL" sanofi-aventis Clinical Supplies Management exhausted the stock of Taxotere 80 mg, specifically labeled for RTOG 0621(US). They will transition to generically labeled material for all future shipments and resupplies. A Note to File from CSM is attached with a complete explanation. Please note that there will be no changes in the description and administration of the drug. All future case registrations or re-orders will receive the generically labelled Taxotere. Any questions regarding the drug supply transition should be addressed to Nisha Kumar at sanofi-aventis at Phone: (908)981-4166 or E-mail: nisha.kumar@sanofi-aventis.com - RTOG0621 US Note to File.pdf 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: October 22, 2009 SUBJECT: RTOG 0534, Updated Updated 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" Update: Eligibility Checklist, Question 25, the prescribed RT dose must be recorded in gray (Gy) rather than centigray (cGy) units. Section 6.1, for clarity, "1.8 Gy per fraction" was added next to each treatment arm immediately above the section and at the end of the "Dose Specifications" paragraph. Section 11.9.5 and Appendix VII, the neurocognitive certification instructions were updated. Institutions can access the complete summary of changes at http://www.rtog.org/members/protocols/0534/summary_changes.html and the Neurocognitive Training Procedure Letter under "Quality of Life Neurocognitive Assessments" (see Section 11.9.5) at http://www.rtog.org/members/forms/0534/main.html Institutions can download a copy of the updated protocol by accessing the RTOG web site at http://www.rtog.org/members/protocols/0534/0534.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. 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: October 22, 2009 SUBJECT: RTOG 0415, Closure Notice Closure Notice 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", will close to patient accrual at 5 PM EST Friday, November 6, 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, 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: October 22, 2009 SUBJECT: RTOG 0825/ACRIN 6686: Corrections Attention RTOG 0825/ACRIN 6686 Principal Investigators and Research Associates: Please note the following corrections to protocol material for RTOG 0825/ACRIN 6686: Summary of Changes for Amendment #2 The originally broadcast summary of changes for Amendment #2 contained an error. In the change description next to Section 10.3.3, the last sentence should read, "Corresponding corrections were made to Appendix II" not "…Appendix I." The summary of changes on the RTOG website has been updated to reflect the correction. ACRIN 6686 Advanced Imaging Sub-Study Portion of Appendix I The current version of RTOG 0825/ACRIN 6686 (version date August 27, 2009; update date September 29, 2009) contains an editorial error in the ACRIN 6686 Advanced Imaging Sub-Study portion of Appendix I. The table found under the second paragraph of "About Advanced Imaging in the Study" contains only three (3) imaging time points and should describe four (4). Please correct this in the site-specific Informed Consent Forms submitted to your local IRB. The table will be corrected at the next amendment and will read as follows: Advanced imaging will take place at four (4) time points: Within 5 days of starting chemoradiation ↓ Within a couple of days of receiving either placebo or bevacizumab ↓ The day of or the day after you receive the placebo or bevacizumab ↓ Seven weeks later, after you have received several cycles of the study treatment (after you are done with chemoradiation) In addition, the description of the Gadolinium Contrast Agent contains reference to "triple dose" that instead should be "double dose"; please use this paragraph content in place of the current content under "Risks." The highlighted text is where "double dose" should appear instead of "triple dose." Gadolinium Contrast Agent. The gadolinium used during the MRI is an FDA-approved MRI contrast agent with very few side effects. The dose used in the advanced MRI tests is "double dose," which is injected rapidly. Some but not all MRI contrast agents have been FDA-approved for double dose, but double dose of all of these agents has been used in many hospitals around the world without evidence of negative effects from the increased dose. Approximately 2 percent of participants experience some side effects with the use of gadolinium; however, they are mostly mild (nausea, headache, hives, temporary low blood pressure). DATE: October 22, 2009 SUBJECT: RTOG 0615, Updated Updated RTOG 0615, "A Phase II Study of Concurrent Chemoradiotherapy Using Three-Dimensional Conformal Radiotherapy (3D-CRT) or Intensity-Modulated Radiation Therapy (IMRT) + Bevacizumab (BV) [NSC 708865; IND 7921] for Locally or Regionally Advanced Nasopharyngeal Cancer" (a closed study): At the request of the RTOG Biospecimen Resource, Sections 10.2.4.2 and 10.3 were updated for blood collection (which continues for some patients on study). Sites can access the complete summary of changes at http://www.rtog.org/members/protocols/0615/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/0615/0615.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 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: October 21, 2009 SUBJECT: RTOG 0825 OCTOBER NEWSLETTER Hello: Attached please find the 825 Newsletter for the month of October. - Cetuximab, Follow-Up to an Investigator Notification, Imclone Systems 09-02-17423-Merck 6052792.pdf Regards, Treena DATE: October 20, 2009 SUBJECT: Form Revision Notice - RTOG 0618 Form Revision 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 The following form for this study has been revised. Download the new version from the RTOG web site @ http://www.rtog.org/pdf_forms.html?members/forms=0618/0618i1.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     10-19-09   Changes: This form was revised to conform with the protocol amendment broadcast on 9/17/09. Question #14 has been revised to indicate that the following criteria no longer apply to eligibility and have been deleted from the code table; item #6 (exercise oxygen consumption >50% predicted). This form is currently available for web data submission. Web-based data submission is mandatory for all forms that are available for web-entry. 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. Mary Gramkowski, RN, BA, CCRP RTOG Data Management DATE: October 19, 2009 SUBJECT: RTOG 0537, Phase II Closure Notice Phase II Closure 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 accrual objective for the phase II portion of this study has been met; the phase II portion of this study will close to patient accrual FRIDAY, OCTOBER 23, AT 5:00 PM EST. All institutions must ship the Codetron® unit to RTOG Headquarters within 1 week following the final treatment of the last patient entered on study at the institution. Return address labels were included in the initial shipment of the Codetron® unit to individual institutions. If you have questions about returning the Codetron® unit, please call RTOG Headquarters at 215-574-3192. Please notify your affiliates that are not on e-mail. 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: October 19, 2009 SUBJECT: RTOG 0539 October Newsletter Attached is the first edition of the newsletter for RTOG 0539, "Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas." Highlights include: Study Summary ARRA Funding/Case Payment Pathology Reminder Information on Recruitment Material Enrollment - 0539 October Newsletter.pdf DATE: October 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/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. Any questions regarding the content of this ESR should be addressed to MG-RD-ESR-Safety-Scientists@bms.com. Kindly include the drug name and ESR number in question in the e-mail header of your query. - Cetuximab, Follow-Up to an Investigator Notification, Imclone Systems 09-02-17423-Merck 6052792.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: October 19, 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" - Trastuzumab, AE-1353951, Protocol RTOG-0524, -FU1.pdf 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. 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: October 16, 2009 SUBJECT:RTOG eNews: RTOG Semiannual Meeting Materials Posted RTOG eNews October 16, 2009 RTOG Semiannual Meeting Materials Posted on Web The RTOG semiannual meeting will be held January 14-17, 2010 at the Tampa Marriott Waterside Hotel in Tampa, Florida. The meeting agenda and brochure (containing hotel and travel information) are available on the RTOG Web site at: http://www.rtog.org/meeting/main.html. We expect the online registration portal to be available soon but attendees may mail or fax in the hard copy registration form is available now on the Web. Applications Being Accepted for RTOG Meeting Awards RTOG offers several different travel awards and grants for each semiannual meeting. The maximum amount of each award/grant is $1,000 to defray the costs of attending the RTOG semiannual meeting. To apply for this funding, the principal investigator must submit a letter of nomination indicating the name of the award or grant that is being sought along with a copy of the faculty member's CV to Sharon Hartson-Stine ( shartson@acr-arrs.org) by November 16, 2009. Please note that several awards have additional requirements. All required materials must be submitted for the application to be considered. Simon Kramer New Investigator Award The RTOG Simon Kramer New Investigator Award is presented semiannually in honor of Simon Kramer, MD, founder and past Group Chair of the RTOG. The twice-yearly award is given to a junior faculty member who has completed a research project that has a direct relationship to the mission of the RTOG. The project can be clinical, translational, or basic science in nature. The awardee receives a stipend of $1,000 travel support for the meeting, and the opportunity to present an abstract at the scientific/plenary session of the RTOG semiannual meeting. The candidate should be a junior faculty member with no more than five years at the instructor or assistant professor level. Full members are eligible to nominate a candidate from their own institution or from an affiliate. A letter of support from the full member principal investigator, and where applicable the affiliate principal investigator, must accompany the nomination. An abstract of the research project as well as the CV of the nominee must also be included along with the letter of nomination. Robert Ginsberg Surgical Oncology Award The Robert Ginsberg Surgical Oncology Award is presented annually in honor of Robert Ginsberg, MD, longtime RTOG investigator and past chair of the RTOG Surgical Oncology Committee. The award is given to a junior faculty member who has completed a research project or paper that has a direct relationship to the mission of the RTOG. The project can be clinical or translational in nature. The awardee receives a stipend of $1,000 travel support for the meeting and the opportunity to present an abstract at the appropriate RTOG disease site committee meeting. The candidate should be a junior faculty member with no more than five years at the instructor or assistant professor level. Full member principal investigators may nominate a candidate from their own institution or from one of their affiliates. A letter of support from the full member principal investigator, and where applicable the affiliate principal investigator, must accompany the nomination. An abstract of the research project as well as the CV of the nominee must also be included in the submission material. Resident / Fellows Travel Award RTOG Resident/Fellow Travel Awards support the travel of senior residents or fellows to attend RTOG semiannual meetings. All principal investigators of full member institutions in good standing may nominate one resident or fellow at their institution or at one of their affiliates for this award. Residents should be at least in the PGY4 year of training and must be in an ACGME accredited residency program. Fellows must be in a recognized training program committed to oncology. First Meeting Medical Oncology Faculty Travel Grant RTOG First Meeting Medical Oncology Faculty Travel Awards are given to board certified/eligible medical oncology faculty members at full member institutions who have not previously attended an RTOG semiannual meeting. Full member principal investigators may nominate one faculty member at their institution or at one of their affiliates for this grant. First Meeting Surgical Oncology Faculty Travel Grant RTOG First Meeting Surgical Oncology Faculty Travel Awards are given to board certified/eligible surgical oncology faculty members at full member institutions who have not previously attended an RTOG semiannual meeting. Full member principal investigators may nominate one faculty member at their institution or at one of their affiliates for this grant. 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: October 16, 2009 SUBJECT: RTOG (0411), (0417), (0615), (0625), (0825) Initial Written Report for Bevacizumab (INDs 7921 & 11460) (NSC 704865) and Epothilone B Analog (BMS-247550) (IND 59699) (NSC 710428) RTOG has received a safety report from the 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 included here does 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 Epothilone B Analog (BMS 247550) AE-1857033, 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: October 14, 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 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=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    TFb     10/13/09   Changes: Question 3a has been changed from “Week 1” to “Week 1-8”. Questions 3b-h have been deleted. Discard obsolete versions and commence use of the revised editions immediately. Institutions who have already submitted this TF form will need to send a revised form to RTOG. This form is currently available for web data submission Web-based data submission is mandatory for all forms that are available for web-entry. 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 that is 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. Joli Lavarino, B.A., CCRP RTOG Data Management DATE: October 14, 2009 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0630 RTOG #0630 A Phase II Trial of Image Guided Preoperative Radiotherapy for Primary Soft Tissue Sarcomas of the Extremity Web-Based Electronic Data Submission is now available for the following forms: I1 (Initial Evaluation Form), TF (Treatment Form), S1 (Surgery Form) and P0 (Wound Assessment 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 e-mail 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 October 30, 2009 will be returned to the site for web submission. Please notify your joint center institutions and affiliates who are not on e-mail. Joli Lavarino, BA, CCRP RTOG Data Management DATE: October 13, 2009 SUBJECT: RTOG 0539, Enhanced Case Payment Announcement Announcement of Enhanced Case Payment RTOG 0539, "Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas" RTOG is pleased to announce that sites accruing to RTOG 0539 will receive an additional $3700 per eligible patient registered, for a total of $5700 per patient. This supplemental funding is made possible by funds received through CTEP's Accelerating Clinical Trials of Novel Oncologic PathWays (ACTNOW) program, under the 2009 American Recovery and Reinvestment Act (ARRA) economic stimulus plan. CTEP designed the ACTNOW program to provide supplemental funds for select novel oncology trials that have the potential to complete accrual within 2 years. CTEP formally selected RTOG 0539 as an ACTNOW recipient in May 2009. DATE: October 13, 2009 SUBJECT: RTOG 0619, Updated Updated 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": Section 7.1.3.1 was updated to instruct institutions to dispense the entire 8 week supply of vandetanib to the patient in the original bottle to ensure stability and shelf life of the study agent. 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 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 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: October 9, 2009 SUBJECT: RTOG 0517 & 0518 Protocol Notice: Novartis SAFETY REPORT FOR ZOMETA RTOG has received safety report(s) from the Novartis for Zometa The Following RTOG study(s) involve Zometa: RTOG 0518 "A Phase III, Double-blind, Placebo-controlled Study 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" RTOG 0517 "Randomized Phase III Trial to Evaluate Radiopharmaceuticals and Zoledronic Acid in the Palliation of Osteoblastic Metastases from Lung, Breast and Prostate Cancer" Please send the report(s) to your institutional IRB. A copy also should be retained in your protocol file. The safety report(s) do not require revisions to the above protocol at this time. - PHOO2008FR09725 10-6-09.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: October 9, 2009 SUBJECT: Endorsed, ECOG E3F05 The following study has been endorsed by the Radiation Therapy Oncology Group and its Brain Tumor Committee: ECOG E3F05, "Phase III Study of Radiation Therapy With or Without Temozolomide for Symptomatic or Progressive Low-Grade Gliomas" RTOG Co-Chair: Lynn Stuart Ashby, MD; Barrow Neurology Clinics; 602-406-6262; lynn.ashby@chw.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 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: October 8, 2009 SUBJECT: Form Revision Notice - RTOG 0622 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 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=0622/0622i1.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     10/08/09   Changes-Q#13: #4 in the table has been deleted to be consistent with the amendment. Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions received after October 16, 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. 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 that is 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 DATE: October 8, 2009 SUBJECT: RTOG 0622, Amended Amended RTOG 0622, "A Phase II Trial Of Samarium 153 Followed By Salvage Prostatic Fossa 3D-CRT Or IMRT Irradiation In High-Risk, Clinically Non-Metastatic Prostate Cancer After Radical Prostatectomy" Amendment 1: The PSA Doubling Time (PSADT) criterion was deleted from the eligibility criteria; the contact information for the Principal Investigator was updated. Institutions can access the complete summary of changes via the RTOG website at http://www.rtog.org/members/protocols/0622/summary_changes.html Institutions can download a copy of the protocol for IRB review at http://www.rtog.org/members/protocols/0622/0622.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. 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 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: October 6, 2009 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0915 Web-Based Electronic Data Submission is now available for the following form: RTOG 0915 (NCCTG N0927) A RANDOMIZED PHASE II STUDY COMPARING 2 STEREOTACTIC BODY RADIATION THERAPY (SBRT) SCHEDULES FOR MEDICALLY INOPERABLE PATIENTS WITH STAGE I PERIPHERAL NON-SMALL CELL LUNG CANCER I1 Form 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 DATE: October 5, 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, Protocl 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: October 5, 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. Any questions regarding the content of this ESR should be addressed to MG-RD-ESR-Safety-Scientists@bms.com. Kindly include the drug name and ESR number in question in the e-mail header of your query. - erbitux-ib12-esr372.pdf - erbitux-ib13-esr371-fu01.pdf - erbitux-ib13-esr364-fu01.pdf - erbitux-ib13-esr365-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: October 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 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, Follow-Up to a Written Report, AE-1419144, 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: October 2, 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. - Bevacizumab CCI-779, AE-1710309, Protocol E2804, -ISR.PDF 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: October 1, 2009 SUBJECT: Request for Data - RTOG 9902 ALL INSTITUTIONS PARTICIPATING IN RTOG 9902 A PHASE III PROTOCOL OF ANDROGEN SUPPRESSION (AS) AND RADIATION THERAPY (RT) VS AS AND RT FOLLOWED BY CHEMOTHERAPY WITH PACLITAXEL, ESTRAMUSTINE, AND ETOPOSIDE (TEE) FOR LOCALIZED, HIGH-RISK, PROSTATE CANCER An upcoming important statistical analysis will be done for RTOG 9902. Please review your OPS tool and submit all outstanding follow up data due through October 31, 2009 to RTOG Headquarters by November 15, 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: September 29, 2009 SUBJECT: RTOG 0617 SEPTEMBER NEWSLETTER Hello: Attached please find the 0617 Newsletter for the month of September. Regards, Treena - RTOG 0617 Newsletter SEPTEMBER 2009.pdf DATE: September 29, 2009 SUBJECT: Endorsed, NCCTG N0577 The following study has been endorsed by the Radiation Therapy Oncology Group and its Brain Tumor Committee: NCCTG N0577, "Phase III Intergroup Study of Radiotherapy versus Temozolomide Alone versus Radiotherapy with Concomitant and Adjuvant Temozolomide for Patients with 1p/19q Codeleted Anaplastic Glioma" RTOG Co-Chair: Michael A. Vogelbaum MD, PhD, FACS; Cleveland Clinic; 216-444-8564; vogelbm@ccf.org 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@phila.acr.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: September 29, 2009 SUBJECT: RTOG 0825/ACRIN 6686, Amended and Updated Amended and Updated RTOG 0825/ACRIN 6686, "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," has been amended and updated. Amendment 1: An advanced imaging substudy, ACRIN 6686, was added. Amendment 2: The statistical portion of the ACRIN substudy was clarified. Update: Various sections were updated to RTOG standard. Sites can access complete Summary of Changes for both amendments and the update at http://www.rtog.org/members/protocols/0825/summary_changes.html Sites can download a copy of the amended and updated protocol for IRB review at http://www.rtog.org/members/protocols/0825/0825.pdf NCI policy requires that the "Version Date" on the protocol title page reflect the date the amendment 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 amendments and update is provided at the top of the summaries of changes. IRB review of an update is not required; however, these changes must be reported to site IRBs 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 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 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: September 29, 2009 SUBJECT: Web Data Submission Update - RTOG 0539 ATTENTION - ALL 0539 PARTICIPANTS!! Effective immediately the 0539 I1 form is available for remote web data entry. All forms submitted on paper after October 2, 2009 will be returned. Thank you, Barbara Kaiser R.N. RTOG Data Management 215-574-3221 DATE: September 29, 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 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-1710309, 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: September 24, 2009 SUBJECT: Computer shut down at RTOG Headquarters end of day Oct. 2nd RTOG Institutions and Investigators Due to a scheduled electrical shut down at RTOG Headquarters, there will no access to the RTOG web site, web registration, or web data entry from 6:30 p.m. Eastern time on Friday, October 2nd until 8:30 a.m. Eastern time on Sunday, October 4th. We apologize for any inconvenience. DATE: September 22, 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 hand corner of the form. Form Type New Version Code/Date I1 Initial Evaluation Form    I1b     9/21/09   Changes Made: Per the recent addendum, patients on Cevimiline are not permitted on the study. This form is currently available for web data submission. 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 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 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 start using this revised form immediately. Please notify your joint center institutions and affiliates who are not on e-mail. Roseann Bonanni, CTR, CCRP RTOG Data Management DATE: September 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-esr337-fu03.pdf - erbitux-ib13-esr361-fu01.pdf - erbitux-ib13-esr371.pdf - erbitux-ib13-esr370.pdf - erbitux-ib13-esr360-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: September 22, 2009 SUBJECT: RTOG 0436, Amended and Updated 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 #2 changes include: Paclitaxel will be provided for Canadian sites and clarification of timing of the PET/CT post treatment and RT data submission. Update: Dr. Konski's contact information updated and a typo corrected in the consent. Please see the complete summary of changes at: http://www.rtog.org/members/protocols/0436/summary_changes.html Sites can download a copy of the 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 editorial/administrative changes were made to the protocol after NCI approved the amendment. NCI requires that these changes be documented on the protocol title page as an update, not as an amendment. 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/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: September 18, 2009 SUBJECT: RTOG 0436 SEPTEMBER NEWSLETTER Hello: Attached please find the 436 Newsletter for the month of September. Regards, Treena - RTOG 0436 Newsletter SEPTEMBER 2009.pdf DATE: September 17, 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 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: September 17, 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-esr369.pdf - erbitux-ib13-esr352-fu02.pdf - erbitux-ib13-esr366-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: September 17, 2009 SUBJECT: RTOG 0815, Updated Updated RTOG 0815, "A Phase III Prospective Randomized Trial of Dose-Escalated Radiotherapy With or Without Short-Term Androgen Deprivation Therapy for Patients With Intermediate-Risk Prostate Cancer" Institutions can access the ACE-27 (Comorbidity Evaluation) on the RTOG website at http://www.rtog.org/members/protocols/0815/ACE-27.pdf A "Note" directing sites to the website for the ACE-27 was added to Section 3.1.4. Note: Sites can also access a Comorbidity Calculator at http://oto2.wustl.edu/clinepi/comorbid.html Sites can access the complete summary of changes at http://www.rtog.org/members/protocols/0815/summary_changes.html Institutions can download a copy of the updated protocol by accessing the RTOG web site at http://www.rtog.org/members/protocols/0815/0815.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: September 17, 2009 SUBJECT: RTOG 0537, Amended Amended RTOG 0537, "A Phase II/III Study Comparing Acupuncture-like Transcutaneous Electrical Nerve Stimulation (ALTENS) Versus Pilocarpine in Treating Early Radiation-Induced Xerostomia", Amendment 1: The pre-registration CT or MRI scan is not required for patients who finished radiation treatment one or more years prior to study entry and there is no clinical evidence of recurrence; the timeframe for prior radiotherapy +/- chemotherapy for head and neck cancers prior to study entry was revised; Appendix VI (Accrual Agreement) is posted on the RTOG website next to the protocol. Institutions can access the complete summary of changes via the RTOG website at http://www.rtog.org/members/protocols/0537/summary_changes.html Institutions can download a copy of the protocol for IRB review at http://www.rtog.org/members/protocols/0537/0537.pdf Appendix VI is available at http://www.rtog.org/members/protocols/0537/Appendix%20VI.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. 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: September 17, 2009 SUBJECT: RTOG 0236, Amended Amended RTOG 0236, "A Phase II Trial of Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Patients with Medically Inoperable Stage I/II Non-Small Cell Lung Cancer" (a closed study); Amendment 6: Patient follow up has been amended from a total of 4 years to include annual follow up for the patient's lifetime. Institutions can access the complete summary of changes at http://www.rtog.org/members/protocols/0236/summary_changes.html Sites can download a copy of the protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/protocols/0236/0236.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. Note: Since this amendment involves changes in the consent form to how long patients will be in the study, RTOG recommends re-consenting all patients enrolled on this trial; however, the local IRB will have the final authority regarding this. 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: September 17, 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 3: The timeframe for required histological confirmation of NSCLC was expanded from 90 days to 180 days. Institutions can access the complete summary of changes at http://www.rtog.org/members/protocols/0618/summary_changes.html Sites can download a copy of the protocol for IRB review by accessing the RTOG web site 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. 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: September 16, 2009 SUBJECT: RTOG 0724, Activated Activated RTOG 0724, "Phase III Randomized Study of Concurrent Chemotherapy and Pelvic Radiation Therapy with or without Adjuvant Chemotherapy in High-Risk Patients with Early-Stage Cervical Carcinoma Following Radical Hysterectomy" Institutions can download a copy of the protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/protocols/0724/0724.pdf Forms for this study can be accessed on the RTOG web site at http://www.rtog.org/members/forms/0724/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. 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: September 15, 2009 SUBJECT: RTOG eNews: RTOG Group Chair, Dr. Walter J. Curran, Named Director of Emory Winship Cancer Institute RTOG eNews September 15, 2009 Walter J. Curran, Jr., M.D., New Executive Director of Emory Winship Cancer Institute Walter J. Curran, Jr., M.D., RTOG Group Chair, has been named the Executive Director of the Emory Winship Cancer Institute and Associate Vice President for Cancer, Woodruff Health Sciences Center. Dr. Curran, who will continue as the RTOG Group Chair, will become the only radiation oncologist in the country to serve as the director of an NCI-designated cancer center. "In the 20 months that Dr. Curran has been at Emory, he turned the cancer center a major accruer to RTOG clinical trials," states Mitchell Machtay, M.D., RTOG Deputy Group Chair and professor and chair of the Department of Radiation Oncology at the Ireland Cancer Center of the University Hospitals Case Medical Center. "His leadership and commitment to cancer research will serve Emory well and continue to enhance RTOG's research mission. As the only radiation oncologist director at an NCI-designated cancer center, this appointment speaks to Dr. Curran's deep, career-long commitment not just to the specialty of radiation oncology but to advancing all of the missions of cancer research and education." Dr. Curran has been the group chair and principal investigator of the RTOG since 1997. Prior to that he served as the group's deputy group chair and chair of its Brain Tumor Committee. Dr. Curran is a Georgia Cancer Coalition Distinguished Scholar, and is the chair of Emory's Department of Radiation Oncology and the medical director of the Emory Winship Cancer Institute. He joined Emory in November 2007 from Jefferson Medical College at Thomas Jefferson University in Philadelphia, where he served as professor and chair of the Department of Radiation Oncology and clinical director for the Kimmel Cancer Center. Dr. Curran graduated cum laude from Dartmouth College, received his MD degree from the Medical College of Georgia, and is a Board Certified Radiation Oncologist. Dr. Curran completed his residency in the Department of Radiation Therapy at the University of Pennsylvania Medical Center and his internship in internal medicine at Presbyterian Medical Center in Philadelphia. 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: September 14, 2009 SUBJECT: RTOG 0815, Activated Activated RTOG 0815, "A Phase III Prospective Randomized Trial of Dose-Escalated Radiotherapy With or Without Short-Term Androgen Deprivation Therapy for Patients With Intermediate-Risk Prostate Cancer" Institutions can download a copy of the protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/protocols/0815/0815.pdf Forms for this study also are available on the RTOG web site at http://www.rtog.org/members/protocols/0815/summary_changes.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/0815/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: September 10, 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-1333814 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: September 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/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-fu03.pdf - erbitux-ib13-esr315-fu02.pdf - erbitux-ib13-esr368.pdf - erbitux-ib13-esr352-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: September 10, 2009 SUBJECT: RTOG 0825 SEPTEMBER NEWSLETTER Hello: Attached please find the 0825 Newsletter for the month of September. Regards, Treena - RTOG 0825 Newsletter SEPTEMBER 2009.pdf DATE: September 10, 2009 SUBJECT: RTOG 0873, Eligibility Worksheet update RTOG 0873, "A Phase III Study Of Active Surveillance Therapy Against Radical Treatment In Patients Diagnosed With Favourable Risk Prostate Cancer (START)" Eligibility Worksheet Updated: Institutions must complete the worksheet using the CTEP Site Code (two letters corresponding to the state, and three numbers, e.g., NC010) for the "Institution Code". The list of CTEP site codes is located online: http://ctep.cancer.gov/protocolDevelopment/docs/Organization_Codes.txt The updated eligibility worksheet is available on the NCIC CTG website (URL below). - WEC 09SEP03.pdf For questions, please contact: Andrea Hiltz, M.Sc. Study Coordinator/GU Disease Site Representative Queen's University NCIC Clinical Trials Group 10 Stuart Street Kingston, Ontario K7L 3N6 Canada Telephone: 613.533.6430 Fax: 613.533.2941 E-mail: ahiltz@ctg.queensu.ca RTOG 0873 is coordinated by NCIC CTG and is available on the NCIC CTG website. Click on the URL below to access the protocol and forms. User Name: RTOG Password: 4rtog2use URL: http://www.ctg.queensu.ca/trials/genito-urinary/pr11/pr11.html DATE: September 9, 2009 SUBJECT: October RTOG Newsletter Attached is the latest version of the RTOG Newsletter. Highlights include: Updates on RTOG Members & Staff Opening of the New Core Lab ASTRO Presentations List New Study Summaries Spinal Metastasis - RTOG 0631 Radiosurgery & SBRT Brain - RTOG 0825 Bevacizumab for GBM Brain - RTOG 0834 Adjuvant Chemo for Anaplastic Glioma Brain - RTOG 0539 Meningioma Lung - RTOG 0915 SBRT for Inoperable Stage I NSCLC Lung - RTOG 0813 SBRT for Early Stage NSCLC Patient Advocate Article 2009 Publications - RTOG_NL_September2009.pdf DATE: September 9, 2009 SUBJECT: RTOG eNews: RTOG 0915 SBRT for NSCLC Opened for Patient Accrual RTOG eNews September 9, 2009 RTOG 0915 SBRT for NSCLC Opened for Patient Accrual RTOG 0915, "A Randomized Phase II Study Comparing 2 Stereotactic Body Radiation Therapy (SBRT) Schedules for Medically Inoperable Patients with Stage I Peripheral Non-Small Cell Lung Cancer," opened to patient accrual on September 3, 2009. Eighty-eight patients with medically inoperable, biopsy-proven early stage T1, T2 (< 5 cm) NSCLC that is clinically node negative by PET, with peripherally located tumors will be entered on the protocol. Patients will be randomly assigned to receive their SBRT in either a single fraction of 34 Gy or in four consecutive daily fractions of 12 Gy for a total dose of 48 Gy. Arm 1: SBRT - 34 Gy in 1 Fraction Arm 2: SBRT - 48 Gy in 4 Fractions (12 Gy once a day for 4 days) The primary objective of this randomized phase II study is to determine which of the two treatment schedules to use a subsequent phase III study as the experimental arm against the current RTOG standard SBRT treatment set by RTOG?0236. The most favorable arm will be determined by the rate of grade 3 or higher adverse events at one-year post therapy. Secondary objectives are to determine the one-year local control, overall survival, and disease-free survival rates as well as an assessment of the FDG PET SUV and pulmonary function changes that can be related to response and outcomes. The association between biomarkers and local control and radiation pneumonitis will also be evaluated. All sites entering patients must use the superposition/convolution or Monte Carlo based dose calculation algorithms. Credentialing for SBRT and heterogeneity corrections by the Advanced Technology Consortium (ATC) is necessary prior to enrolling patients on this study. See Section 5.2 for complete information about completing the credentialing process. The principal Investigator of this study is Gregory M.M. Videtic, M.D., of the Cleveland Clinic Foundation (216-444-9797, videtig@ccf.org). The study is available at: http://www.rtog.org/members/protocols/0915/0915.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 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: September 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-esr366.pdf - erbitux-ib13-esr286-fu03.pdf - erbitux-ib13-esr367.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: September 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, AE-1279067, Protocol AEWS0521, -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: September 3, 2009 SUBJECT: RTOG 0813, Guidelines for institutions on RTOG web site Sites interested in participating in 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": Guidelines for institutions, including contacts for questions regarding approval status, regulatory pre-registration requirements, and the status of SBRT credentialing, can be accessed on the RTOG web site at http://www.rtog.org/members/protocols/0813/0813%20Institution%20Guidelines.pdf Please notify your affiliates that are not on e-mail. DATE: September 3, 2009 SUBJECT: RTOG 0915 (NCCTG N0927), Activated Activated RTOG 0915 (NCCTG N0927), "A Randomized Phase II Study Comparing 2 Stereotactic Body Radiation Therapy (SBRT) Schedules for Medically Inoperable Patients with Stage I Peripheral Non-Small Cell Lung Cancer" Institutions can download a copy of the protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/protocols/0915/0915.pdf Forms for this study can be accessed on the RTOG web site at http://www.rtog.org/members/forms/0915/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/0915/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: September 1, 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-esr356-fu01.pdf - erbitux-ib13-esr321-fu04 (2).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: September 1, 2009 SUBJECT: Form Revision Notice - RTOG 0534 RTOG Study # 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 The following forms(s) for this study have been revised. Download the new version from the RTOG web site at http://www.rtog.org/members/webreg.html The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date F0c        9/01/09   Changes Made: electronic data submission for lab values has been corrected Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions received after September 11, 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, CTR, CCRP RTOG Data Management DATE: September 1, 2009 SUBJECT: RTOG Registration Desk Closure for Labor Day Updated 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", (a closed study): Section 7.3.1 was updated to refer sites to the RTOG web site for the cetuximab investigator's brochure, and contact information for the Outcomes Co-Chair and Senior Statistician was updated. Sites can access a complete summary of changes for the update at http://www.rtog.org/members/protocols/0522/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/0522/0522.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 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: September 1, 2009 SUBJECT: RTOG 0436, 0521, 0525, 0617, 0619 & 0834 Protocol Notice: Holiday Hours for Drug Distributor Biologics Biologics Clinical Trial Services will be closed for the Labor Day holiday on Monday, Sept. 7, 2009. We will resume regular business hours on Tuesday, Sept. 8. If you have questions or need to coordinate shipments in advance, please don't hesitate to contact your Clinical Trial Project Manager at 800-693-4906. RTOG Clinical Trail Manager for RTOG Studies: Karl Buer Kbuer@biologicstoday.com Ext. 4991 DATE: September 1, 2009 SUBJECT: RTOG Registration Desk Closure for Labor Day The RTOG Registration Desk will be closed for the Labor Day holiday on Friday, September 4th, at 3:00 p.m. EST and will remain closed on Monday, September 7th. The Registration Desk will re-open Tuesday, September 8th at 8:30 a.m. EST. Institutions can access web registration 24 hours a day, 7 days a week; see information and instructions at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html Please notify your affiliates that are not on e-mail. DATE: August 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-esr365.pdf - erbitux-ib13-esr364.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: August 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/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-esr362.pdf - erbitux-ib13-esr363.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: August 26, 2009 SUBJECT: RTOG 0617 AUGUST NEWSLETTER Hello: Attached please find the 0617 Newsletter for the month of August. RTOG 0617 Newsletter AUGUST 2009.pdf Regards, Treena DATE: August 25, 2009 SUBJECT: RTOG 0537, ALTENS therapy Codetron FAQs posted on RTOG web site Attention Investigators for RTOG 0537, A Phase II/III Study Comparing Acupuncture-like Transcutaneous Electrical Nerve Stimulation (ALTENS) Versus Pilocarpine in Treating Early Radiation-Induced Xerostomia An ALTENS therapy "Frequently Asked Questions" sheet for the Codetron® unit is now posted on the RTOG web site next to the protocol: http://www.rtog.org/members/protocols/0537/0537%20FAQ.doc If you have questions about the shipping/receiving of the Codetron® unit, please contact Christina Freeman at 215-574-3192. DATE: August 25, 2009 SUBJECT: Important Information Regarding Storage of Specimens Important Information Regarding Storage of Specimens Many recent RTOG protocols include the instruction in the blood collection appendix to "store [blood] samples at -80°C until packed and shipped in dry ice." RTOG HQ has received feedback from some institutions that they do not have access to a -80°C freezer for storage of specimens (serum, buffy coat, etc.) prior to shipment. The RTOG Biospecimen Resource has provided the following alternatives for sites without access to -80°C freezer. These alternatives will be added, as appropriate, to new RTOG protocols going forward and to current RTOG protocols in future amendments: If a -80°C freezer is not available for storage of blood specimens prior to shipment to the RTOG Biospecimen Resource: Samples can be stored short term in a -20° C freezer (non-frost free preferred) for up to 1 week (please ship out Monday-Wednesday only). OR Samples can be stored in plenty of dry ice for up to one week, replenishing daily (please ship out on Monday-Wednesday only). OR Samples can be stored in liquid nitrogen vapor phase (ship out Monday-Wednesday only). Please indicate the storage conditions used and time stored on the Specimen Transmittal Form. DATE: August 25, 2009 SUBJECT: RTOG 0436 AUGUST NEWSLETTER Hello: Attached please find the 0436 Newsletter for the month of August. - RTOG 0436 Newsletter AUGUST 2009.pdf Regards, Treena DATE: August 25, 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-1670060, Protocol 6980, -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: August 24, 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, -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: August 21, 2009 SUBJECT: RTOG eNews: RTOG 0631 Activated, RTOG Authors Alert, Protocol Closures RTOG eNews August 21, 2009 RTOG 0631 for Spinal Metastases Activated RTOG 0631: Phase II/III Study of Image-Guided Radiosurgery/SBRT for Localized Spine Metastasis RTOG has launched a landmark randomized study, RTOG 0631, testing the role of stereotactic radiation for patients with localized (1-3) spine metastases. This phase II/III study will involve a 2:1 randomization between image-guided spinal radiosurgery (SRS)/stereotactic body radiotherapy (SBRT) (16 Gy in 1 fx) vs. external beam radiotherapy (EBRT) (8 Gy in 1 fx), the optimal arm of the prior RTOG 9714 study. In RTOG 9714, approximately 50% of patients still had significant pain at 3 months after receiving 8 Gy/1 fx EBRT (similar to 30 Gy in 10 fx). The goal of RTOG 0631 is to see if a higher biological dose (16 Gy), delivered precisely via SRS/SBRT, will result in a 40% relative improvement in pain relief. This unique, randomized study is critical to determining the "added value" of modern technological strategies in this setting. Any technology that meets the study QA requirements is allowed, however participating institutions must be credentialed prior to enrolling their first patient. Sites previously credentialed for IMRT and IGRT will not be automatically credentialed for this study. Sites must first irradiate a special spine phantom, provided by the Radiologic Physics Center (RPC), http://rpc.mdanderson.org/rpc; select "Credentialing" and "RTOG"; as detailed in section 5.1 of the protocol. This phantom is designed to credential sites for the Intesity-modulated radiation therapy (IMRT) component of the study. An additional step is the credentialing that sites must do for image-guided radiotherapy (IGRT). See sections 5.1 and 5.2 of the protocol for more information. Also please note that there is a phase II feasibility component involving a rapid review of two SRS/SBRT cases from each institution by the study principal investigator Samuel Ryu, MD, at Henry Ford Hospital (see section 6 of the protocol). In the phase III randomized study portion of the study the primary endpoint is pain relief at the treated site (using the numerical pain scale) with QOL as a key secondary endpoint. In addition to Dr. Ryu, the co-chairs of the study include Benjamin Movsas, MD, of Henry Ford Health System (quality of life), Peter Gerszten, MD, MPH, of the University of Pittsburgh Medical Center (neurosurgery); Fang-Fang Yin, PhD, Duke University Medical Center (physics); Robert D. Timmerman, MD, University of Texas Southwestern (IGRT); Adam Dicker, MD, PhD, Thomas Jefferson University (translational research), and Meihua Wang, PhD, Radiation Therapy Oncology Group/ACR (statistics). Sites will receive one RTOG case credit for each patient enrolled on the study and the standard $2,000 case reimbursement. For CCOP sites this study awards one DCP credit. The protocol is available on the RTOG Web site. RTOG Authors - Reporting Requirements Most investigators submitting abstracts and manuscripts using RTOG data or research funded by RTOG seed grants know that they must submit their abstract or manuscript to the RTOG Publications Committee for approval prior to submission to the intended journal or society meeting reviewers. It is also important that first authors notify the RTOG publications office (RTOG_Publications@acr-arrs.org) when they receive an acceptance or rejection notice from the journal or society and it is especially important to notify us when an author is informed of the print date of the article. This allows RTOG to maintain an accurate list of or publications, notify NCI, and plan for news releases and other appropriate types of publicity. If you have questions concerning publicity for RTOG research or events please contact Sharon Hartson (shartson@acr-arrs.org). Thanks You to Participants in RTOG 0424 Temozolomide for High Risk Low-Grade Gliomas & RTOG 0320 Stereotactic RT for Brain Mets RTOG is pleased to announce that accrual has been completed for RTOG 0424, A Phase II Study of Temozolomide-Based Chemoradiotherapy Regimen for High-Risk Low-Grade Gliomas. The trial closed to accrual on August 11th meeting its accrual goal with a total enrollment of 136 participants. The trial's primary aim is to evaluate the 3-year survival of high-risk low-grade glioma patients treated with concurrent temozolomide and radiotherapy followed by 12 cycles of temozolomide. The investigators will also evaluate the association between MGMT methylation status and survival and progression-free survival as well as evaluate the toxicity, quality of life and neurocognitive function of patients treated with this regimen. Thank you to all who enrolled patients on this study. Accrual for RTOG 0424 - Temozolomide for High-Risk Low-Grade Glioma Inst Name Accrual Metro-MN CCOP 10 Thomas Jefferson University Hospital 10 McGill University 9 Akron City Hospital 6 Arlington Cancer Center 6 Christiana Care Health Services, Inc. 6 Tel-Aviv Medical Center 6 Ridgeview Medical Center 5 The Ottawa Hospital Regional Cancer Centre 5 University of Texas Southwestern Medical School 5 University of Wisconsin Hospital 5 Fox Chase Cancer Center 4 MD Anderson Cancer Center - Orlando 4 Cleveland Clinic Foundation 3 Kaiser Permanente Los Angeles Medical Center 3 Riverview Medical Center/Riverview Regional Cancer Center 3 Cancer Care Manitoba Foundation 2 Florida Radiation Oncology Group / Baptist Regional 2 Mt. Sinai Comprehensive Cancer Center CCOP 2 Sentara Norfolk General Hospital 2 Sparta Cancer Center 2 St. Alphonsus Regional Medical Center 2 St. John's Mercy Medical Center 2 St. Louis University Hospitals 2 Thompson Cancer Survival Center 2 University of Texas Medical Branch 2 University of Utah Health Science Center 2 University of Wisconsin Cancer Center Johnson Creek 2 Clarian Health Partners, Inc. 1 ICON- Baptist Medical Center South 1 McKay-Dee Hospital 1 Medical College of Wisconsin 1 Natalie Warren Bryant Cancer Center at St. Francis Hospital 1 Nevada Cancer Research Foundation 1 Pomona Valley Hospital Medical Center 1 St. Agnes Healthcare 1 University of Rochester 1 Virginia Mason CCOP 1 Wayne State University-Karmanos Cancer Institute 1 West Michigan Cancer Center CCOP 1 Total 126 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, closed to patient accrual on August 11th. The trial accrued 126 patients since it opened in October 2004 but fell short of its accrual goal of 381 patients. The primary goal of the study is to determine if either temozolomide or erlotinib combined with WBRT and SRS improves survival compared to WBRT and SRS alone. Thank you to all who enrolled patients on this trial. Accrual RTOG 0320 - Stereotactic RT for Brain Metastases Inst Name Accrual Metro-MN CCOP 10 Thomas Jefferson University Hospital 10 McGill University 9 Akron City Hospital 6 Arlington Cancer Center 6 Christiana Care Health Services, Inc. 6 Tel-Aviv Medical Center 6 Ridgeview Medical Center 5 The Ottawa Hospital Regional Cancer Centre 5 University of Texas Southwestern Medical School 5 University of Wisconsin Hospital 5 Fox Chase Cancer Center 4 MD Anderson Cancer Center - Orlando 4 Cleveland Clinic Foundation 3 Kaiser Permanente Los Angeles Medical Center 3 Riverview Medical Center/Riverview Regional Cancer Center 3 Cancer Care Manitoba Foundation 2 Florida Radiation Oncology Group / Baptist Regional 2 Mt. Sinai Comprehensive Cancer Center CCOP 2 Sentara Norfolk General Hospital 2 Sparta Cancer Center 2 St. Alphonsus Regional Medical Center 2 St. John's Mercy Medical Center 2 St. Louis University Hospitals 2 Thompson Cancer Survival Center 2 University of Texas Medical Branch 2 University of Utah Health Science Center 2 University of Wisconsin Cancer Center Johnson Creek 2 Clarian Health Partners, Inc. 1 ICON- Baptist Medical Center South 1 McKay-Dee Hospital 1 Medical College of Wisconsin 1 Natalie Warren Bryant Cancer Center at St. Francis Hospital 1 Nevada Cancer Research Foundation 1 Pomona Valley Hospital Medical Center 1 St. Agnes Healthcare 1 University of Rochester 1 Virginia Mason CCOP 1 Wayne State University-Karmanos Cancer Institute 1 West Michigan Cancer Center CCOP 1 Total 126 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: August 21, 2009 SUBJECT: RTOG 0521, Closure Closure 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" will close to patient accrual at 5 PM EST today, Friday, August 21, because the study has met its accrual objective. Notice of this closure was previously broadcast on August 7, 2009. 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: August 20, 2009 SUBJECT: RTOG 0521, Amended and Updated Amended and Updated 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. Amendment 5: The contact information for the Principal Investigator, Dr. Sandler, was updated. Section 10.0 (tissue specimen collection) was revised-a paraffin-embedded tissue block of tumor is preferred; options are given if the tissue block cannot be obtained. Please see the complete Summary of Changes for the amendment at: http://www.rtog.org/members/protocols/0521/summary_changes.html You may download a copy of the protocol for IRB review by accessing the RTOG web site at: http://www.rtog.org/members/protocols/0521/0521.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. IRB review of the update is not required; however, this change must be reported to site IRBs. 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: August 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-esr306-fu03.pdf - erbitux-ib13-esr361.pdf - erbitux-ib13-esr360.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: August 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-1836781, Protocol GOG-0218, -FU1.pdf - Bevacizumab, AE-1833568, 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: August 20, 2009 SUBJECT: RTOG 0524, Amended and Re-Opened Amended and Re-Opened to Patient Accrual 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", has been amended and re-opened to patient accrual (temporary suspension of accrual was previously broadcast on 6/5/09). Amendment 4: The toxicities/risks associated with radiation therapy to the pelvis were amended in Section 6.10 and in Appendix I to include bowel perforation. 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 protocol for IRB review by accessing the RTOG web site at: http://www.rtog.org/members/protocols/0524/0524.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. Note: Institutions cannot enroll new patients to this trial until local IRB approval of amendment 4 is received by CTSU. In addition, since this amendment involves changes to the risks section of the consent, RTOG recommends re-consenting patients on this trial; however, the local IRB will have the final authority regarding this. 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: August 19, 2009 SUBJECT: Attention all participants in studies 9813, 0320 and 0525 Attention all participants in studies 9813, 0320 and 0525 Data is needed for important statistical analysis. Please review the OPS tool and submit all outstanding data for studies 9813, 0320 and 0525 by October 1st, 2009 Thank you for your cooperation. Barbara Kaiser R.N. RTOG Data Management (215) 574-3221 DATE: August 13, 2009 SUBJECT: RTOG eNews: RTOG 9003 TRP Results Published in JCO RTOG eNews August 17, 2009 RTOG 9003 TRP Results Published Online Early in JCO RTOG Validates Lysyl Oxidase as a Prognostic Marker for Metastasis and Survival for Patients with Head and Neck Squamous Cell Carcinoma It is now possible to identify head and neck cancer patients who have a higher risk of developing distant metastases or suffering a relapse according to an early release of new research by Radiation Therapy Oncology Group (RTOG) investigators published online and in an upcoming issue of the Journal of Clinical Oncology. RTOG is a National Cancer Institute-funded national cooperative clinical trials group. Using tumor biopsies and data from 306 patients entered on RTOG 9003, a phase III multicenter randomized trial of four radiation therapy schedules for locally advanced head and neck squamous cell carcinoma, investigators found that an increase in lysyl oxidase (LOX) expression is a predictor for the development of distant metastases, disease progression and overall survival. LOX is an enzyme associated with hypoxia, or a reduction in tissue oxygen, which is thought to increase the likelihood of disease spread (metastases). "This important study from the RTOG Translational Research Program is the first to validate a hypoxia marker, LOX, that identifies patients who have a higher probability of developing spread of disease in a prospective, phase III RTOG head and neck trial," said Adam Dicker, M.D., Ph.D., chair of the RTOG Translational Research Program and Professor and Interim Chairman, Department of Radiation Oncology Director-Christine Baxter Research Laboratory for Experimental Cancer Therapeutics, Thomas Jefferson University. "This was performed using both traditional immunohistochemistry as well as a cutting edge image analysis tool-AQUA (automated quantitative analysis). We plan to incorporate the LOX biomarker in our upcoming clinical trials." According to Quynh-Thu Le, M.D., the lead author on the study and professor in the Department of Radiation Oncology at Stanford University, "We have validated LOX as a marker for metastasis, and thereby the significance of hypoxia, in head and neck cancer patients treated with radiation therapy. We plan to continue our investigations of the prognostic abilities of LOX through future studies with patients treated with concurrent chemoradiotherapy and determine the impact of LOX in relation to HPV (human papillomavirus) status, another known prognostic marker in these cancers." Dr. Le and her team initially performed traditional immunohistochemical (IHC) and AQUA staining on 66 tumor samples from Stanford University and found that LOX expression was predictive of a decrease in the time to metastasis. They subsequently used AQUA on 306 patients entered on the multicenter RTOG study and found that an increase in LOX expression was an independent predictor of time to metastasis (hazard ratio [HR], 1.21 for every 10 unit increment of LOX protein expression; 95% CI, 1.10 to 1.33; P = .0001), time to disease progression (HR, 1.06; 95% CI, 1.02 to 1.10; P = .0069), and overall survival (HR, 1.04; 95% CI, 1.00 to 1.07; P = .0311). This translates into a 259% increase in metastatic risk for a patient at the 75th percentile of LOX compared with one at the 25th percentile. "This exciting new research highlights the group's commitment to developing novel therapies to prevent and treat cancer by defining treatment strategies based on each patient's personalized tumor characteristics," 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. The publication is available at: http://jco.ascopubs.org/cgi/content/abstract/JCO.2008.20.6003v1 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: August 13, 2009 SUBJECT: Web-Based Electronic Data Submission Update RTOG 9703 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 e-mail 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 August 21, 2009 will be returned to the site for web submission. Please notify your joint center institutions and affiliates who are not on e-mail. Joli Lavarino, BA, CCRP RTOG Data Management DATE: August 12, 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-esr359.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: August 11, 2009 SUBJECT: RTOG 0631, Updated Updated RTOG 0631, "Phase II/III Study of Image-Guided Radiosurgery/SBRT for Localized Spine Metastasis" Section 6.7, 1st sentence: "1st case from each institution" was corrected to "first 2 cases from each institution" Sites can access the complete summary of changes at http://www.rtog.org/members/protocols/0631/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/0631/0631.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. 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: August 11, 2009 SUBJECT: RTOG 0424, Closure Notice Closure Notice RTOG 0424, " A Phase II Study of Temozolomide-Based Chemoradiotherapy Regimen for High Risk Low-Grade Gliomas," will close to patient accrual at 5 PM EST today, Tuesday, August 11, because the study has met its accrual objective. (Notice of this closure was previously broadcast on 7/28/09.) Please notify your affiliates who 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: August 11, 2009 SUBJECT: RTOG 0320, Closure Notice Closure Notice 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," will close to patient accrual at 5 PM EST today, Tuesday, August 11, because the study has not met its accrual objective. (Notice of this closure was previously broadcast on 7/28/09.) Please notify your affiliates who 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: August 7, 2009 SUBJECT: RTOG 0631, Activated Activated RTOG 0631, "Phase II/III Study of Image-Guided Radiosurgery/SBRT for Localized Spine Metastasis" Institutions can download a copy of the protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/protocols/0631/0631.pdf Forms for this study also are available on the RTOG web site at http://www.rtog.org/members/forms/0631/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/0631/summary_changes.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: August 7, 2009 SUBJECT: RTOG 0521 Closure Notice Closure Notice 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" will close to patient accrual at 5 PM EST Friday, August 21, 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/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: August 6, 2009 SUBJECT: RTOG 0627 Form Revision RTOG Study #0627 Study Title: Phase II trial of dasatinib in patients with recurrent glioblastoma multiforme Form Revision The Central Pathology Form (P4) for this study has been revised. Download the new version from the RTOG web site at http://www.rtog.org/members/forms/0627/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 P4    P4     08/05/09   Changes Made: Address for the shipment of tissue has been changed to Dr Ken Aldape's department. Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions received after 8/20/09 will be returned to the site for transcription. Please notify your joint center institutions and affiliates who are not on e-mail. RTOG Data Management DATE: August 6, 2009 SUBJECT: RTOG 0415, Amended Amended 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 3: Changes were made to Sections 10, 11, and to Appendix I. Sites can access the complete summary of changes at http://www.rtog.org/members/protocols/0415/summary_changes.html. Sites can download a copy of the protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/protocols/0415/0415.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/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: August 5, 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, -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: August 5, 2009 SUBJECT: RTOG eNews: RTOG 9309 NSCLC Results Published in The Lancet RTOG eNews August 5, 2009 RTOG 9309 NSCLC Results Published in The Lancet RTOG/Intergroup Phase III Study: No Overall Survival Advantage for Chemo-Radiation Followed by Surgery Over Chemo-Radiation Alone for Patients with Stage IIIA (N2) Non-Small-Cell Lung Cancer Performing surgery following concurrent chemotherapy and radiotherapy for patients with stage IIIA (N2) non-small-cell lung cancer does not lead to better overall survival rates than chemotherapy and radiotherapy alone, according to a landmark Radiation Therapy Oncology Group (RTOG) study published online on July 27, 2009 and in an upcoming edition of The Lancet. Surgery following radiotherapy and chemotherapy did not improve overall survival; however it did produce better progression free survival rates than chemotherapy and radiation alone. Radiotherapy plus chemotherapy, with or without surgery, may both be viable treatment options for patients with stage IIIA (N2) non-small-cell lung cancer. The patients who did appear to have a benefit from added surgery were those in which a selection of the lung (lobe) was removed, rather than the entire lung. "This is a one-of-a-kind study in a common form of lung cancer, where the difference in the two groups of patients being compared was the use of surgery. Survival for each group was better than past experience, so patients deserve to learn about both options. And, from our study we know that for selected patients, using all 3 treatment modalities available - chemotherapy, radiation, and surgery - may yield a superior outcome in delay relapse and improved survival," said RTOG 9309 Principal Investigator Kathy Albain, MD, Loyola University Chicago Stritch School of Medicine, Cardinal Bernardin Cancer Center. In this randomized controlled trial, the authors compared concurrent chemotherapy and radiotherapy followed by surgery with standard concurrent chemotherapy and radiotherapy without surgery, the current standard for this group of patients. Those patients with stage IIIA (N2) non-small-cell lung cancer were randomly assigned to concurrent induction chemotherapy (two cycles of cisplatin [50 mg/m² on days 1, 8, 29, and 36] and etoposide [50 mg/m² on days 1-5 and 29-33]) plus radiotherapy (45 Gy) in multiple academic and community hospitals. If no progression, patients in group 1 underwent surgery and those in group 2 continued radiotherapy uninterrupted up to 61 Gy. Two additional cycles of cisplatin and etoposide were given in both groups. The primary endpoint was overall survival (OS). 202 patients (median age 59 years, range 31-77) were assigned to group 1 and 194 (61 years, 32-78) to group 2. Median OS was 23.6 months in group 1 versus 22.2 months in group 2 (a non-statistically significant difference).The 5 year survival rate was 27% for group 1 and 20% for group 2. Progression free survival (PFS) was significantly better in group 1 than in group 2, median 12.8 months versus 10.5 months; the PFS rate at 5 years for group 1 was 22% and for group 2 was 11%. Lower white blood cell counts (neutropenia) and esophagitis were the main grade 3 or 4 toxicities associated with chemotherapy plus radiotherapy in group 1 (77 [38%] and 20 [10%], respectively) and group 2 (80 [41%] and 44 [23%], respectively). In group 1, 16 (8%) deaths were treatment related versus 4 (2%) in group 2. In an exploratory analysis, OS was improved for patients who underwent lobectomy, but not pneumonectomy, versus chemotherapy plus radiotherapy. The authors suggest the reason for an absence of effect of surgery could be inadequate power in the trial or reduced delivery of later chemotherapy (cycles 3 and 4) in the surgery group. However they say the mostly likely reason could be increased mortality following pneumonectomy, mainly due to acute respiratory distress syndrome and other respiratory causes. The authors conclude: "Chemotherapy plus radiotherapy with or without resection (preferably lobectomy) are options for patients with stage IIIA (N2) non-small-cell lung cancer... medically healthy patients with stage IIIA (N2) non-small-cell lung cancer should be assessed by a team skilled in multimodality treatment, and treatment options can be considered during assessment. On the basis of the findings of our study, patients should be counseled about the risks and potential benefits of definitive chemotherapy plus radiotherapy with and without a surgical resection (preferably by lobectomy)." "This trial is a major step forward in understanding how to integrate complex multi-disciplinary management of patients with this very challenging stage of lung cancer. All the co-authors, investigators, and participating patients and families should be strongly commended for this landmark trial," said Walter J. Curran, Jr., MD, the RTOG Group Chair, and the Lawrence W. Davis Professor and chairman of the Department of Radiation Oncology in the Emory School of Medicine and chief medical officer of the Emory Winship Cancer Institute. Non-small-cell lung cancer makes up some 80% of lung cancers, and its most common cause is long-term exposure to tobacco smoke. Of all cases of non-small-cell lung cancer, the disease is locally advanced in the chest only in about 30% (stage IIIA), where front-line surgery cannot cure the disease because it has already spread to lymph nodes in the centre of the chest (N2). The publication is available at: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(09)60737-6/fulltext 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: August 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 NOTE FROM BMS: Due to an administrative error, the clinical team at BMS was inadvertently dropped from the Imclone distribution list for the Erbitux ESRs during the period between May 21 - July 13, 2009. Attached are 28 ESRs and follow-ups that were issued during this time period. 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-esr357.pdf - erbitux-ib13-esr358.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: August 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 NOTE FROM BMS: Due to an administrative error, the clinical team at BMS was inadvertently dropped from the Imclone distribution list for the Erbitux ESRs during the period between May 21 - July 13, 2009. Attached are 28 ESRs and follow-ups that were issued during this time period. 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. - DDL 331-fu02.pdf - DDL 329-fu02.pdf - DDL 327-fu01.pdf - DDL 326-fu02.pdf - DDL 326-fu01.pdf - DDL 323-fu02.pdf - DDL 321-fu03.pdf - DDL 267-fu02.pdf - DDL 352.pdf - DDL 351.pdf - DDL 350-fu01.pdf - DDL 350.pdf - DDL 349.pdf - DDL 348.pdf - DDL 347.pdf - DDL 346-fu02.pdf - DDL 346-fu01.pdf - DDL 346.pdf - DDL 345-fu01.pdf - DDL 345.pdf - DDL 344.pdf - DDL 343.pdf - DDL 342.pdf - DDL 341.pdf - DDL 338-fu01.pdf - DDL 337-fu02.pdf - DDL 333-fu01.pdf - DDL 331-fu03.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: August 4, 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-1438181, Protocol E5103, -FU2.pdf - Bevacizumab, AE-1232396, Protocol E5202, -FU1.pdf - Bevacizumab Sunitinib malate, AE-1613977, Protocol 7537, -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: August 4, 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, AE-1263182, Protocol S0325, -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: August 4, 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, -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: August 4, 2009 SUBJECT: RTOG 0825 NEWSLETTER Hello: Attached please find the 0825 Newsletter for the month of August. Regards, Treena - RTOG 0825 Newsletter AUGUST 2009.pdf DATE: August 3, 2009 SUBJECT: IMPORTANT RTOG CHANGES: IRB/REB Continuing Review of closed RTOG studies for the US and Canada must be submitted to the CTSU Please Note: EFFECTIVE IMMEDIATELY all continuing review approvals for closed RTOG studies must be submitted to the CTSU using the same procedure and paperwork currently used for initial approvals and amendment submissions. IRB approval must continue on all RTOG studies where patients have been enrolled until all collected data from your institution is completely reconciled by RTOG. Although no further data may be collected, it may remain unreconciled and generate queries that require clarification after study closure. Continuing IRB approval remains necessary, even after study closure and until formal notification is received from RTOG regarding study termination while these transactions are still taking place. Continuing reviews of closed studies can be by expedited review and must be submitted to CTSU and maintained in the study file. A study can only be classified as "terminated" by RTOG when the data base is locked and the paper is published or a decision is made not to publish. A broadcast notice indicating study termination will be sent to all participating sites at the appropriate time. ONLY studies where no patients have ever been enrolled can be closed by the site with the IRB prior to termination IMPORTANT NOTE Full member institutions that have affiliates that use the Full Member IRB as their IRB of record must ensure that those affiliate/Joint Center institutions had also never enrolled any patients on studies they are considering closing with the IRB. If they have, then the main IRB must keep this study open for annual continuing review. DATE: July 31, 2009 SUBJECT: Form Revision Notice - RTOG 0526 FORM REVISION RTOG 0526 A PROSPECTIVE PHASE II TRIAL OF TRANSPERINEAL ULTRASOUND-GUIDED BRACHYTHERAPY FOR LOCALLY RECURRENT PROSTATE ADENOCARCINOMA FOLLOWING EXTERNAL BEAM RADIOTHERAPY The following form for this study has been revised. Download the new version from the RTOG web site: http://www.rtog.org/pdf_forms.html?members/forms=0526/0526i1.pdf The edition code for the case report forms is found in the lower right hand corner of the form. Form Type New Version Code/Date I1 Initial Evaluation Form    I1b     7/30/09   Changes made: Q 19: An additional fraction size is now allowed for prior prostate RT. This form is currently available for web data submission Web-based data submission is mandatory for all forms that are available for web-entry. 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 that is collected on the forms should be directed to RTOG Data Management at 215-574-3214. Please start using this revised form immediately. Please notify your joint center institutions and affiliates who are not on our broadcast e-mail. Elaine Motyka-Welsh, RN, MSN, CCRP RTOG Data Management DATE: July 30, 2009 SUBJECT: RTOG 0526, Amended Amended RTOG 0526, "A Prospective Phase II Trial Of Transperineal Ultrasound-Guided Brachytherapy For Locally Recurrent Prostate Adenocarcinoma Following External Beam Radiotherapy", Amendment #1: EBRT dose: Section 3.2.2 now states that patients that have received EBRT dose to the prostate that exceeded 78 Gy (2 Gy fractions) or 79.8 Gy (1.9 Gy fractions) or 81 Gy (1.8 Gy fractions) are not eligible for participation in the study. Sites can access the complete summary of changes at http://www.rtog.org/members/protocols/0526/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/0526/0526.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. 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: July 30, 2009 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 9902 RTOG 9902 A PHASE III PROTOCOL OF ANDROGEN SUPPRESSION (AS) AND RADIATION THERAPY (RT) VS AS AND RT FOLLOWED BY CHEMOTHERAPY WITH PACLITAXEL, ESTRAMUSTINE, AND ETOPOSIDE (TEE) FOR LOCALIZED, HIGH-RISK, PROSTATE CANCER Web-Based Electronic Data Submission is now available for the following form: RTOG 9902 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. Paper forms received after 8/15/09 will be returned so they can be submitted via the web. Elaine Motyka-Welsh, RN, MSN, CCRP Research Associate DATE: July 29, 2009 SUBJECT: RTOG Email Address Format Change Dear RTOG Members and Colleagues, This announcement is to clarify the new email address that you may have noticed when you've been receiving emails from RTOG Headquarters, which is housed in the ACR Clinical Research Center in Philadelphia, PA. The governing boards of the American College of Radiology (ACR) and the American Roentgen Ray Society (ARRS) have reached an agreement in principle for a strategic integration merger that will leverage the strengths of each organization. July 1, 2009 was the effective date for the Strategic Integration. As part of the ACR/ARRS integration, we have changed over to a new e-mail address format effective 6/30/09. The external email address that appears on email will be the first initial of first name + last name + @acr-arrs.org (i.e. Adriane Owens would be aowens@acr-arrs.org). Our existing e-mail addresses will continue to work, and we will still be able to receive mail on our old e-mail addresses (e.g. name@phila.acr.org). All documentation (protocols, manuals, staff lists) which list staff email addresses will be updated in the future. Thank you. DATE: July 28, 2009 SUBJECT: RTOG 0424, Closure Closure Notice RTOG 0424, " A Phase II Study of Temozolomide-Based Chemoradiotherapy Regimen for High Risk Low-Grade Gliomas," will close to patient accrual at 5 PM EST Tuesday, August 11, 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: Junly 28, 2009 SUBJECT: RTOG 0320, Closure Closure Notice 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," will close to patient accrual at 5 PM EST Tuesday, August 11, because 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: July 24, 2009 SUBJECT: Form Revision Notice - RTOG 0539 RTOG 0539 Phase II Feasibility of IMRT for intermediate and High Risk Meningiomas and Observation for Low Risk Meningiomas Forms 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=0539/0539I1.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     7-24-09   Changes Made: Schema numbers corrected to allow specify for question #6 "prior other type of treatment". Discard obsolete versions and commence use of the revised edition immediately. Obsolete versions received after 8/2/2009 will be returned to the site for transcription. Please notify your joint center institutions and affiliates who are not on e-mail. Contact Barbara Kaiser R.N., RTOG Data Management @ 215-574-3221 with questions DATE: July 23, 2009 SUBJECT: Minimal Risk Studies and Expedited Initial Local IRB Approval RTOG has received many inquiries regarding the acceptability of sites providing expedited initial local IRB review/approval of several RTOG studies, which initially appear to present no more than minimal risk to human subjects (Guidance criteria attached). PLEASE NOTE: The following determinations have been made and will be enforced at the time of a site audit: RTOG 0612 - The ACR/RTOG will require full board approval due to the study requirement of an additional biopsy RTOG 0514 - The American College of Radiology IRB has determined that the following study presents no more than minimal risk to human subjects and thus qualifies for expedited review. However, your local IRB has final authority over the study and may reach a different conclusion RTOG 0828 - The American College of Radiology IRB has determined that the following study presents no more than minimal risk to human subjects and thus qualifies for expedited review. However, your local IRB has final authority over the study and may reach a different conclusion RTOG 0841 - The ACR/RTOG will require full board approval due to the noted exception (C) under applicability in the attached guidance document. RTOG plans to make the determination regarding the acceptability of expedited initial reviews/approvals for studies that appear to involve no more than minimal risk to human subjects, when appropriate, prior to study activation going forward. This information will be noted in the activation broadcast. Thank you, American College of Radiology 1818 Market Street, Suite 1600 Philadelphia, PA 19103 - -humansubjects-guidance- documents.htm DATE: July 22, 2009 SUBJECT: RTOG 0834/EORTC 26053_22054/NCIC CTG CEC.1, Activated Activated RTOG 0834/EORTC 26053_22054/NCIC CTG CEC.1: Phase III Trial on Concurrent and Adjuvant Temozolomide Chemotherapy in Non-1p/19q Deleted Anaplastic Glioma: The CATNON Intergroup Trial Special Study Notes: EORTC is the lead group for this study, and RTOG is acting as the lead group in North America. United States RTOG sites can download a copy of the protocol, Group-Specific Appendix for United States Sites, and forms for IRB review by accessing the CTSU website at https://www.ctsu.org and going to the CTSU members' site (requires CTSU user name and password). All Canadian sites will enroll through NCIC CTG via NCIC CTG procedures. 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 (for 88 patients/arm) per eligible patient registered. Sites will receive an additional $2000 per eligible patient registered, for a total of $4000 per patient. Please notify your affiliates who 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 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. - erbutix-ib13-esr356.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 21, 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, -FU1.pdf Note: You will need "Adobe Acrobat Reader" to read t