Member Update FUTURE MEETINGS: January 13-16, 2011 at Manchester Grand HyattSan Diego, CA DATE: August 31, 2010 SUBJECT: RTOG 96-16 (CALGB 9633): Terminated by CALGB Terminated RTOG 96-16 (CALGB 9633), "A Phase III Study of Adjuvant Chemotherapy After Resection for Patients with T2N0 Stage I Non-Small Cell Carcinoma of the Lung", was terminated by CALGB, the coordinating group, effective 8/15/10. All study activity and data collection for this study should cease, and institutions should notify their IRBs/REBs of the termination. Any data received after 8/15/10 will be returned to the submitting institution. 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: August 31, 2010 SUBJECT: Form Revision Notice - RTOG 0539 PHASE II TRIAL OF OBSERVATION FOR LOW-RISK MENINGIOMAS AND OF RADIOTHERAPY FOR INTERMEDIATE AND HIGH-RISK MENINGIOMAS 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/pdf_forms.html?members/forms=0825/0825SR.pdf. The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date SR Radiology Review Form SRb - 8/26/10 Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions received after 9/8/2010 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 e-mail websupport@acr-arrs.org Please notify your joint center institutions and affiliates who are not on e-mail. DATE: August 31, 2010 SUBJECT: Biospecimen Resource holiday hours The RTOG Biospecimen Resource will be closed Monday September 6th in observance of the Labor Day Holiday. Please do not ship any frozen bio-specimens Thursday (Sept 2nd) or Friday (Sept 3rd) We will reopen at 8.30 am (PST) on Tuesday September 7th. Please notify your affiliates that are not on e-mail. Please contact us at rtog@ucsf.edu (415-476-7864) for any questions. American College of Radiology 1818 Market Street, Suite 1600 Philadelphia, PA 19103 DATE: August 30, 2010 SUBJECT: RTOG 0848 and 0320 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR ERLOTINIB RTOG has received safety report(s) from NCI for ERLOTINIB (OSI-774). 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 Erlotinib (OSI-774): 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-1531241, 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 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 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 Erica Thorson, MPH Regulatory Compliance Associate II Radiation Therapy Onocology Group Phone: 215-940-8824 Fax: 215-574-0300 ethorson@acr-arrs.org American College of Radiology 1818 Market Street, Suite 1600 Philadelphia, PA 19103 DATE: August 30, 2010 SUBJECT: RTOG 0837 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR CEDIRANIB RTOG has received safety report(s) from NCI for CEDIRANIB 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 CEDIRANIB: RTOG 0837 " 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 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. - AZD2171, AE-1469546, Protocol 7534, -FU#1.pdf - AZD2171, Investigator Notification, AstraZeneca Manufacturer Report #2009SE03195, August 13, 2010.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at 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 American College of Radiology 1818 Market Street, Suite 1600 Philadelphia, PA 19103 DATE: August 30, 2010 SUBJECT: RTOG Registration Desk closure for Labor Day holiday The RTOG Registration Desk will close at noon EST on Friday, September 3rd and will remain closed on Monday, September 6th for the Labor Day holiday. The Registration Desk will reopen on Tuesday, September 7th 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://clinicalweb1.phila.acr.org/ClinicalRtog/faces/jsp/index.jsp Please notify your affiliates that are not on e-mail. DATE: August 26, 2010 SUBJECT: RTOG 0539 August 2010 Newsletter Attached is the August 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: Technologic Advances in the Treatment of Meningiomas Enrollment - 0539 August Newsletter.pdf DATE: August 26, 2010 SUBJECT: RTOG 0621, Closure Notice Closure Notice RTOG 0621, "ADJUVANT 3DCRT/IMRT IN COMBINATION WITH ANDROGEN SUPPRESSION AND DOCETAXEL FOR HIGH RISK PROSTATE CANCER PATIENTS POST-PROSTATECTOMY: A PHASE II TRIAL" will close to patient accrual at 5 PM EST, Wednesday September 9th, because the study has met its accrual objective. Please notify your affiliates that are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, 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 24, 2010 SUBJECT: RTOG 0929 password protected on RTOG website Due to an agreement with Abbott Laboratories, our industry sponsor for RTOG 0929, "A Randomized Phase I/II Study of ABT-888 in Combination With Temozolomide in Recurrent (Temozolomide Resistant) Glioblastoma," the protocol has been password protected on the RTOG website. To access the protocol: Go to http://www.rtog.org/members/numericactive.html, select RTOG 0929, and enter your RTOG Login ID and Password when prompted. DATE: August 20, 2010 SUBJECT: RTOG 0537 - Form Revision Notice RTOG # 0537 A Phase II/III Study Comparing Acupuncture-like Transcutaneous Electrical Nerve Stimulation (ALTENS) Versus Pilocarpine in Treating Early Radiation-Induced Xerostomia 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=0537/0537HP.pdf The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date HP UWHNSS HPa 8-11-10 Changes Made: Question 1: Pretreatment was added as one of the time points. Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions received after September 1, 2010 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. Vanita Patel, MS RTOG Research Associate Web registration is available 24/7. Information and instructions available at https://clinicalweb1.phila.acr.org/ClinicalRtog/faces/jsp/index.jsp DATE: August 20, 2010 SUBJECT: Form Revision Notice - RTOG 0518 RTOG 0518 Phase III randomized trial to evaluate the efficacy of Zometa® for the prevention of osteoporosis and associated fractures in patients receiving radiation therapy and long term LHRH agonists for high-grade and/or locally advanced prostate cancer 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=0518/0518hp.pdf The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date HP Health Utility (EQ-5D) HPa 8-19-10 Changes Made: Form pages were re-numbered and page 4 was removed as this page was attached in error Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions received after September 1, 2010 will be returned to the site for transcription. Please notify your joint center institutions and affiliates who are not on e-mail. Elaine Motyka-Welsh, RN, MSN, CCRP RTOG Research Associate Web registration is available 24/7. Information and instructions available at https://clinicalweb1.phila.acr.org/ClinicalRtog/faces/jsp/index.jsp DATE: August 20, 2010 SUBJECT: Upcoming Important Statistical Analysis for RTOG 0525 ALL INSTITUTIONS PARTICIPATING IN RTOG 0525 An important statistical analysis is being planned for RTOG 0525. Please review your OPS tool and submit all outstanding data due through August 31st, 2010 to RTOG Headquarters by September 10th, 2010. Please notify your joint center institutions and affiliates who are not on e-mail. Please contact Barbara Kaiser, R.N. @ 215-574-3221 with questions. Thank you for your cooperation. Web registration is available 24/7. Information and instructions available at https://clinicalweb1.phila.acr.org/ClinicalRtog/faces/jsp/index.jsp DATE: August 19, 2010 SUBJECT: RTOG (0417),(0615), (0625), (0825) & (0921) PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received a safety report 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 (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. 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 - Bevacizumab, AE-1900497, Protocol CALGB-90601, -FU1.pdf DATE: August 19, 2010 SUBJECT: NOTICE: NCI/NIH SAFETY REPORT FOR ABT-888 RTOG has received safety reports from NCI for ABT-888 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 ABT-888: RTOG 0929, "A RANDOMIZED PHASE I/II STUDY OF ABT-888 IN COMBINATION WITH TEMOZOLOMIDE IN RECURRENT (TEMOZOLOMIDE RESISTANT) 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. 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 - 10P-163-0660904-00.pdf - 10P-163-0660959-00.pdf DATE: August 13, 2010 SUBJECT: RTOG 0929 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR ABT-888 RTOG has received safety reports from NCI for ABT-888 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 ABT-888: RTOG 0929, "A RANDOMIZED PHASE I/II STUDY OF ABT-888 IN COMBINATION WITH TEMOZOLOMIDE IN RECURRENT (TEMOZOLOMIDE RESISTANT) 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. 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 - 10P-163-0652366-00.pdf - 10P-163-0660411-01.pdf - 10P-163-0660461-02.pdf - 10P-163-0660549-01.pdf - 10P-163-0660578-00.pdf - 10P-163-0660899-00.pdf - 10P-163-0660930-00.pdf DATE: August 11, 2010 SUBJECT: New RTOG Regulatory Team Member It is our pleasure to introduce the newest member of the RTOG Regulatory Team Erica Thorson. Erica, who joined our team in July as a Regulatory Associate II, will be involved in all aspects of RTOG Regulatory Compliance with a primary focus on Canada. Erica's contact information is attached. Please give her a warm welcome. Erica Thorson Regulatory Associate II RTOG ethorson@acr-arrs.org Office:(215) 940-8824 Fax:(215) 574-0300 Address: 1818 Market St. Suite 1600 Philadelphia, PA 19103 United States of America Thank you, American College of Radiology 1818 Market Street, Suite 1600 Philadelphia, PA 19103 DATE: August 11, 2010 SUBJECT: RTOG 0436 Dose Prescription Clarification **Attention Investigators With Potential Patients for RTOG 0436 "Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients with Esophageal Cancer who are treated without surgery." PLEASE READ BELOW FOR CLARIFICATION OF PROTOCOL RT DOSE PRESCRIPTION. *** REFER TO SECTION 6.1.4 FROM RTOG 0436 PROTOCOL TEXT AND PLAN RT DOSE ACCORDINGLY. SPECIFICALLY, PRESCRIPTION IS TO PERIPHERY OF PTV AND IS FOR TOTAL DOSE OF 50.40 Gy, NOT 50.40 Gy TO ISOCENTER: "Dose Specifications 6.1.4 The total dose for both arms will be 50.4 Gy (1.8 Gy/Fx/day) prescribed to the periphery (93% isodose curve) of the PTV." This can be achieved by prescribing 1.94 Gy/ day to the isocenter not 1.80 Gy/day. DATE: August 10, 2010 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0813 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 Web-Based Electronic Data Submission is now available for the following form: A5 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 8/16/2010 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 Web registration is available 24/7. Information and instructions available at https://clinicalweb1.phila.acr.org/ClinicalRtog/faces/jsp/index.jsp DATE: August 10, 2010 SUBJECT: RTOG 0627, Closure of Stage 1B Cohort To Occur today, Tuesday 8/10 Closure of Stage 1B Cohort The stage 1B cohort of RTOG 0627, "Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme," will close to patient accrual at 5 PM EST today Tuesday, August 10, because it has accrued the required number of patients. (Notice of this closure was broadcast on July 27, 2010.) Accrual to this protocol will be suspended while data from the stage 1B cohort are analyzed to determine whether there is sufficient evidence of response to proceed to the next stage of accrual. A broadcast will be sent when this decision has been made. 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 9, 2010 SUBJECT: RTOG 0627 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR DASATINIB RTOG has received a safety report from NCI for DASATINIB 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 DASATINIB: RTOG 0627: PHASE II TRIAL OF DASATINIB IN PATIENTS WITH RECURRENT GLIOBLASTOMA MULTIFORME 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. 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 - BMS-354825, AE -1983486, Protocol AALL0622,-FU1.pdf DATE: August 9, 2010 SUBJECT: RTOG 0929 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR ABT-888 RTOG has received safety reports from NCI for ABT-888 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 ABT-888: RTOG 0929, "A RANDOMIZED PHASE I/II STUDY OF ABT-888 IN COMBINATION WITH TEMOZOLOMIDE IN RECURRENT (TEMOZOLOMIDE RESISTANT) 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. 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 - 10P-163-0648710-00.pdf - 10P-163-0657198-01.pdf - 10P-163-0657458-00.pdf - 10P-163-0659862-00.pdf - 10P-163-0660559-02.pdf DATE: August 4, 2010 SUBJECT: RTOG 0837 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR CEDIRANIB RTOG has received safety report(s) from NCI for CEDIRANIB 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 CEDIRANIB: RTOG 0837 " 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 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. 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 - AZD2171, AE-1306759, Protocol 8348, -ISR.PDF DATE: August 4, 2010 SUBJECT: RTOG (0411),(0417),(0615), (0625), 0825 & 0921 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety reports 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. 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 Bevacizumab, Follow-Up to a Written Report, AE - 1190366, Protocol GOG-0252, -FU1.pdf Bevacizumab, AE - 1295253, Protocol E5103, -FU1.pdf Bevacizumab CCI-779, AE - 1671222, Protocol E2804, -FU1.pdf DATE: August 4, 2010 SUBJECT:RTOG 0929 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR ABT-888 RTOG has received safety report(s) from NCI for ABT-888 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 ABT-888: RTOG 0929, "A RANDOMIZED PHASE I/II STUDY OF ABT-888 IN COMBINATION WITH TEMOZOLOMIDE IN RECURRENT (TEMOZOLOMIDE RESISTANT) 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. 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 - 10P-163-0654000-00.pdf DATE: August 2, 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 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/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 I1 Initial Evaluation Form I1a 08/02/10 TF Treatment Summary Form TFb 08/02/10 SF Systemic Treatment Summary Form SFb 08/02/10 Changes Made:I1: Question #5: All parentheticals referring to staging were removed. Question #13: Wording changed. Question #14: Removed (referring to 24-hour urine) SF/TF: Lab sheets changed to include UPC (Protein creatinine ratio) These forms are currently available for web data submission Please notify your joint center institutions and affiliates who are not on e-mail. D. Grant, RN, MSN RTOG Research Associate Web registration is available 24/7. Information and instructions available at https://clinicalweb1.phila.acr.org/ClinicalRtog/faces/jsp/index.jsp DATE: July 29, 2010 SUBJECT: RTOG 1014, Updated for OPEN Updated RTOG 1014, "A Phase II Study of Repeat Breast Preserving Surgery and 3D-Conformal Partial Breast Re-Irradiation(PBRI) for Local Recurrence of Breast Carcinoma," was updated for implementation of CTSU's Oncology Patient Enrollment Network (OPEN), the web-based registration system for patient enrollments onto NCI-sponsored cooperative group clinical trials. OPEN provides the ability to enroll patients on a 24/7 basis. Effective immediately, the RTOG web registration system for RTOG 1014 will no longer be available and, when accessed, will direct sites to the OPEN registration link. To access OPEN you must have: a current CTEP-IAM account Be aligned with an institution on an organization roster in RSS (CTSU roster, Cooperative Group roster, or other network roster) For more information on OPEN please visit the CTSU member site. Sites can access the complete summary of changes for the 1014 update at http://www.rtog.org/members/protocols/1014/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/1014/1014.pdf The "Update Date" on the protocol title page indicates that editorial/administrative changes were made to the protocol. IRB review of an update is not required; however, these changes must be reported to site IRBs. Please notify your affiliates that are not on e-mail. DATE: July 28, 2010 SUBJECT: Form Revision Notice - RTOG 0920 RTOG #0920 A PHASE III STUDY OF POSTOPERATIVE RADIATION THERAPY (IMRT) +/- CETUXIMAB FOR LOCALLY-ADVANCED RESECTED HEAD AND NECK 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/0920/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     7/23/10 F0 Initial Follow-up Form    F0a     7/23/10 F1 Follow-up Form    F1a     7/23/10   Changes Made: I1: Added Question# 9h (element# 56) ENT or Head and Neck Surgeon Examination Changed Question# 22 Severe Active Co-morbidities (element#380) Electrolytes (CTCAE v 4 grade 3-4) Changed instructions for Protocol Specific Adverse Event Evaluation (element# 451) to the use of CTCAE version 4 (MedDRA 12) to code all events. F0: CTCAE Terms and version changed to current CTCAE version 4, MedDRA 12 for Questions# 11 and #12 (element# 121-208) Changed instructions for Question #13 New Continuing Adverse Events (element# 300-395) to the use of CTCAE version 4 (MedDRA 12) to code all events F1: CTCAE Terms and version changed to current CTCAE version 4, MedDRA 12 for Questions# 15 and #16 (element# 121-208) Changed instructions for Question #17 New Continuing Adverse Events (element# 300-395) to the use of CTCAE version 4 (MedDRA 12) to code all events. These forms are currently available for web data submission Please notify your joint center institutions and affiliates who are not on e-mail. Joli L. Rueter, BA, CCRP RTOG Research Associate DATE: July 28, 2010 SUBJECT: RTOG 0920, Amendment 1: Corrected summary of changes Corrected summary of changes for amendment 1 of RTOG 0920 The summary of changes for amendment 1 of RTOG 0920, "A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally-Advanced Resected Head and Neck Cancer", (the amendment was previously broadcast on June 9th) has been corrected (the deletion of the previously required HCO3 in Section 11.2.2 and Appendix II was incorrectly reported in the prior summary and has now been added under the changes made to Section 3.1.10). Sites can access the corrected summary of change for amendment 1 (below the summary for amendment 2) at: http://www.rtog.org/members/protocols/0920/summary_changes.html We apologize for this error and any inconvenience it may cause. Please notify your affiliates that are not on e-mail. DATE: July 27, 2010 SUBJECT: RTOG 0617 JUNE & JULY 2010 NEWSLETTER Hello: Attached please find the 0617 Newsletter for the months of June and July. Regards, Treena - RTOG 0617 Newsletter June July 2010.pdf DATE: July 27, 2010 SUBJECT: RTOG 0436 JUNE & JULY 2010 NEWSLETTER Hello: Attached please find the RTOG 0436 Newsletter for the months of June and July. Regards, Treena - RTOG 0436 Newsletter JUNE JULY 2010.pdf DATE: July 27, 2010 SUBJECT: RTOG 0627, Closure of Stage 1B Cohort To Occur Tuesday 8/10 Closure of Stage 1B Cohort The stage 1B cohort of RTOG 0627, "Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme," will close to patient accrual at 5 PM EST on Tuesday, August 10, because it has accrued the required number of patients. Accrual to this protocol will be suspended while data from the stage 1B cohort are analyzed to determine whether there is sufficient evidence of response to proceed to the next stage of accrual. A broadcast will be sent when this decision has been made. 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 27, 2010 SUBJECT: RTOG 0921, Amended Amended 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" Amendment 1: In response to a request for an amendment (RA) from CTEP, the protocol was amended to reflect a revised CAEPR for bevacizumab. In addition, monitoring of proteinuria by UPC ratio was clarified. Amendment 2: The risk profile for carboplatin was added to the informed consent because it was inadvertently omitted. Sites can access the complete summary of changes for Amendment 1 and Amendment 2 at http://www.rtog.org/members/protocols/0921/summary_changes.html Sites can download a copy of the protocol for IRB review by accessing the RTOG web site http://www.rtog.org/members/protocols/0921/0921.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 of the amendment 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. 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: July 23, 2010 SUBJECT: Form Revision Notice - RTOG 0920 RTOG #0920 A PHASE III STUDY OF POSTOPERATIVE RADIATION THERAPY (IMRT) +/- CETUXIMAB FOR LOCALLY-ADVANCED RESECTED HEAD AND NECK 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/0920/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 DL DLQ    DLa     6/11/10 L4 Xe-QOL    L4a     6/11/10   Changes Made: DL - Changed page number from 1 of 3 to 1 of 2 on the coversheet L4 - Changed page number from 1 of 4 to 1 of 3 on the coversheet TF: Phase was changed from Phase II to Phase III on this form but the version date was not changed. These forms are currently available for web data submission Please notify your joint center institutions and affiliates who are not on e-mail. Joli Lavarino-Rueter, BA, CCRP RTOG Research Associate DATE: July 22, 2010 SUBJECT: RTOG 0627, Amended & Updated Amended and Updated RTOG 0627, "Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme" Amendment 8 Starting October 1, 2010, AdEERS for RTOG 0627 must be reported using CTCAE version 4.0. Related changes were made to Section 7.7. All AE reporting on the study case report forms and dose modification decisions will continue to use CTCAE version 3.0. Update The Fed Ex account number was updated in Appendix V. Sites can access the summaries of changes for the amendment and update at http://www.rtog.org/members/protocols/0627/summary_changes.html Sites can download a copy of the protocol for IRB review by accessing the RTOG web site http://www.rtog.org/members/protocols/0627/0627.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 of the amendment 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 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. IRB review of an update is not required; however, these changes must be reported to site IRBs. DATE: July 21, 2010 SUBJECT: RTOG 0614, Closure Notice Closure Notice RTOG 0614, "A Randomized, Phase III, Double-Blind, Placebo-Controlled Trial of Memantine for Prevention of Cognitive Dysfunction in Patients Receiving Whole-Brain Radiotherapy," will close to patient accrual at 5 PM EST, today, Wednesday July 21, because the study has met its accrual objective. (Notice of this closure was broadcast on July 7, 2010.) Please notify your affiliates that are not on e-mail. DATE: July 19, 2010 SUBJECT: RTOG 0436, 0617, and 0920: Revised CTEP Action Letter--Accrual is NOT suspended Important Information for RTOG 0436, 0617, and 0920 CTEP has just issued a revised Action Letter for Cetuximab (attached) with the clarification that trials with a CTEP status of "Active" do not need to temporarily close to accrual while IRB approval is sought for the approved Action Letter amendment. Accrual of new patients is NOT suspended to the following RTOG studies while the IRB of record reviews and approves the CTEP-approved amendment that addresses the information in the Action Letter. These amendments were previously broadcast on 7/9/10. 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 3 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", Amendment 6 RTOG 0920, "A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally-Advanced Resected Head and Neck Cancer", Amendment 2 - Action Letter_cetuximab_NSC 714692_v 2 1_OTHER TRIALS REVISED.PDF Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. This amendment involves changes to the risks section of the consent, and RTOG recommends re-consenting patients on this trial; however, your local IRB will have the final authority. NCI policy requires that the "Version Date" on the protocol title page reflect the date that the most recent amendment was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses. Please notify your affiliates that are not on e-mail. DATE: July 16, 2010 SUBJECT:Password Policy Change for RTOG Web Data Entry Beginning Saturday, 6/19 there will be a new policy regarding passwords. This policy will be expanded to include both internal and external applications including all Web Data Entry applications. This change includes requirements that the password be at least 8 characters long, that it contain characters and numbers and that it be changed every 90 days. You'll see this change the first time you log-in after Saturday. At that point you'll be prompted to change your password and when you do it'll have to conform to this policy: Password must be at least 8 characters. Password must have at least 1 alpha character. Password must have at least 1 numeric character. User passwords must be unique relative to the previous eight passwords used. Passwords shall be valid for no more than 90 days and no less than 30 days. People accessing the Web data entry sites will immediately be prompted to click the Change Password button. When they do they will enter their current ID and password along with a new "conforming" password. Please see example below: Default Password Message. After the implementation of Password policy all accounts will be reset. Users will be prompted with the default password message as shown below. "Your Default Password must be changed before logon to the system." RTOG: DATE: July 15, 2010 SUBJECT: RTOG 0841, Updated Updated RTOG 0841, "Efficiency of Screening for Depression in Cancer Patients Receiving Radiotherapy", Update: A "note" regarding the limited participation (CCOPs only until January 2011) for this study was added to the Title Page. In Appendix I (sample consent), the text under "What will happen if I take part in this research study/During the research study…", was revised for clarity regarding study procedures. Please see the complete Summary of Changes at http://www.rtog.org/members/protocols/0841/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/0841/0841.pdf The "Update Date" on the protocol title page indicates that editorial/administrative changes were made to the protocol.IRB review of an update is not required; however, these changes must be reported to site IRBs. REMINDER REGARDING AMENDMENTS 1 AND 2 Because this Update of the protocol closely follows a recent Amendment broadcast (7/1/10), sites that have not yet received approval for Amendments 1 and 2 can incorporate this Update into the amendment submission to the local IRB. Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. Given the extent of the changes to the protocol, Full Board Review is required. All previous IRB approvals have been expired NCI policy requires that the "Version Date" of the protocol title page reflect the date that the amendment was submitted by RTOG to NCI. For clarity, the broadcast date of the amendment 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. Please notify your CCOP affiliates that are not on e-mail. DATE: July 14, 2010 SUBJECT: Endorsed, GOG-0263 The following study has been endorsed by the Radiation Therapy Oncology Group and its Gynecologic Cancer Working Group: GOG-0263, "Randomized Phase III Clinical Trial of Adjuvant Radiation Versus Chemoradiation in Intermediate Risk, Stage I/IIA Cervical Cancer Treated With Initial Radical Hysterectomy and Pelvic Lymphadenectomy " RTOG Co-Chair: William Small Jr, MD; Northwestern Memorial Hospital; 312-926-6810; wsmall@nmff.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. DATE: July 13, 2010 SUBJECT: RTOG 0514, Closure Closure RTOG 0514, "Establishment of a Head and Neck Tissue/Specimen Repository", will close to patient accrual at 5 PM EST today, July 13th, as the study has met its objectives. (Notice of this closure was previously broadcast on 6/29/10.) Note: When RTOG 0514 is closed, sites will submit specimens according to the instructions in each RTOG head and neck protocol. Please notify your affiliates that are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, please e-mail 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: July 9, 2010 SUBJECT: RTOG 0837 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR CEDIRANIB RTOG has received safety report(s) from NCI for CEDIRANIB 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 CEDIRANIB: RTOG 0837 " 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 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. - AZD2171, AE-1856685, Protocol 7309, -FU 1.pdf DATE: July 9, 2010 SUBJECT: RTOG 0920, Action Letter and Amendments Action Letter and Amendments RTOG 0920, "A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally-Advanced Resected Head and Neck Cancer", has been amended as follows: Amendment 1: In Section 3.2.5.8, the required parameter for potassium was corrected; changes also were made to Appendices I and II. Amendment 2: RTOG has received an Action Letter from NCI/NIH for cetuximab (NSC 714692; IND #103444) and has amended the protocol accordingly. Sites can access the complete summaries of change for Amendment 1 and Amendment 2 at: http://www.rtog.org/members/protocols/0920/summary_changes.html Sites can download a copy of the amended protocol for IRB review at: http://www.rtog.org/members/protocols/0920/0920.pdf Accrual of new patients to RTOG 0920 is SUSPENDED until the IRB of record has reviewed and approved the CTEP-approved amendment (amendment 2) for this study that addresses the information in the Action Letter (attached). Sites should submit the amendments and Action Letter to their site IRBs, and retain a copy in the site protocol file. Note: RTOG has expired all prior IRB approvals for the study. U.S. and Canadian sites must fax a copy of the IRB/REB approval letter to the CTSU Regulatory Office (215-569-0206) prior to registering patients. Patients currently on study may continue on study provided they are informed of the new risks identified as part of the CAEPR update in the Action Letter. Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. This amendment involves changes to the risks section of the consent, and RTOG recommends re-consenting patients on this trial; however, your local IRB will have the final authority. NCI policy requires that the "Version Date" on the protocol title page reflect the date that the most recent amendment was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses. Please 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: July 9, 2010 SUBJECT: RTOG 0617/NCCTG N0628/CALGB 30609/ECOG R0617: Action Letter and Amendment Action Letter and Amendment 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" Amendment 6: RTOG has received an Action Letter from NCI/NIH for cetuximab (NSC 714692; IND #103444) and has amended the protocol accordingly. Sites can access the complete Summary of Changes for the amendment at http://www.rtog.org/members/protocols/0617/summary_changes.html Sites can access the amended protocol at: http://www.rtog.org/members/protocols/0617/0617.pdf Accrual of new patients to RTOG 0617 is SUSPENDED until the IRB of record has reviewed and approved the CTEP-approved amendment for this study that addresses the information in the Action Letter (attached). Sites should submit the amendment and Action Letter to their site IRBs, and retain a copy in the site protocol file. Note: RTOG has expired all prior IRB approvals for the study. U.S. and Canadian sites must fax a copy of the IRB/REB approval letter to the CTSU Regulatory Office (215-569-0206) prior to registering patients. Patients currently on study may continue on study provided they are informed of the new risks identified as part of the CAEPR update in the Action Letter. Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. This amendment involves changes to the risks section of the consent, and RTOG recommends re-consenting patients on this trial; however, your local IRB will have the final authority. NCI policy requires that the "Version Date" on the protocol title page reflect the date that the most recent amendment was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses. Please 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. - Action Letter cetuximab, NSC 714692.pdf DATE: July 9, 2010 SUBJECT: RTOG 0436, Action Letter and Amendment Action Letter and Amendment 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 3: RTOG has received an Action Letter from NCI/NIH for cetuximab (NSC 714692; IND #103444) and has amended the protocol accordingly. Sites can access the complete Summary of Changes for the amendment at http://www.rtog.org/members/protocols/0436/summary_changes.html Sites can access the amended protocol at: http://www.rtog.org/members/protocols/0436/0436.pdf Accrual of new patients to RTOG 0436 is SUSPENDED until the IRB of record has reviewed and approved the CTEP-approved amendment for this study that addresses the information in the Action Letter (attached). Sites should submit the amendment and Action Letter to their site IRBs, and retain a copy in the site protocol file. Note: RTOG has expired all prior IRB approvals for the study. U.S. and Canadian sites must fax a copy of the IRB/REB approval letter to the CTSU Regulatory Office (215-569-0206) prior to registering patients. Patients currently on study may continue on study provided they are informed of the new risks identified as part of the CAEPR update in the Action Letter. Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. This amendment involves changes to the risks section of the consent, and RTOG recommends re-consenting patients on this trial; however, your local IRB will have the final authority. NCI policy requires that the "Version Date" on the protocol title page reflect the date that the most recent amendment was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses. Please notify your affiliates that are not on e-mail. --- Action Letter cetuximab, NSC 714692.pdf 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: July 8, 2010 SUBJECT: RTOG June 2010 Meeting Evaluation Forms Hello: Thank you for your attendance at our recent semi-annual meeting. Attached please find two evaluation forms: one for the Symposium on Comparative Effectiveness and the other for the Disease Site Committee Meetings. Kindly complete an evaluation form for each of the sessions you attended. Your feedback is invaluable to the planning for future offerings and also plays a vital role in our ability to continue to offer CME credits for our semi-annual meetings. Completed evaluations should be faxed to 703-716-1283. Thank you in advance for your input. RTOG June 2010 Symposium Evaluation Form.doc RTOG June 2010 Disease Site Session Evaluation Form.doc DATE: July 8, 2010 SUBJECT: RTOG 0539 June/July 2010 Newsletter Attached is the June/July 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: New Light on Atypical Meningiomas Amendment 1 Recap Enrollment - 0539 June_July Newsletter.pdf DATE: July 7, 2010 SUBJECT: RTOG 0837 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR CEDIRANIB RTOG has received safety report(s) from NCI for CEDIRANIB 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 CEDIRANIB: RTOG 0837 " 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 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. - AZD2171, AE-1130115, Protocol 8030, -FU 1.pdf DATE: July 7, 2010 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. 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. - Dasatinib (BMS-354825), AE 1983486, Protocol AALL0622, -ISR.PDF DATE: July 7, 2010 SUBJECT: RTOG 0929 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR ABT-888 RTOG has received safety report(s) from NCI for ABT-888 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 ABT-888: RTOG 0929, "A RANDOMIZED PHASE I/II STUDY OF ABT-888 IN COMBINATION WITH TEMOZOLOMIDE IN RECURRENT (TEMOZOLOMIDE RESISTANT) 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. 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. - ABT-888, Follow-up to a Written Report, AE- 1222444, Protocol PBTC-027, -FU1.pdf 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@phila.acr.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 atwww.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: July 7, 2010 SUBJECT: RTOG 0614, Closure Notice Closure Notice RTOG 0614, "A Randomized, Phase III, Double-Blind, Placebo-Controlled Trial of Memantine for Prevention of Cognitive Dysfunction in Patients Receiving Whole-Brain Radiotherapy," will close to patient accrual at 5 PM EST, Wednesday July 21, because the study has met its accrual objective. Please notify your affiliates that are not on e-mail. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, please e-mail 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: July 1, 2010 SUBJECT: RTOG 0841, Amended and Re-Opened to Accrual Amended and Re-opened to Accrual RTOG 0841, "Efficiency of Screening for Depression in Cancer Patients Receiving Radiotherapy" Amendment 1: Dr. Wagner is now the Principal Investigator for the study. The protocol was revised to address concerns regarding screening procedure details and to include information regarding the addition of the psychosocial services questionnaire (Appendix VII) that institutions will need to complete at study activation. The study endpoints were revised as a result of changes made to the study objectives in Section 2.0. Amendment 2: The Rationale and Justification for the study have been revised to reflect revisions to the secondary study objectives. The registration procedures were revised to clearly articulate responsibilities of participating institutions. Update: The SCID Modules were removed from the protocol appendix and are posted next to the protocol on the RTOG web site. Sites can access the complete summaries of changes for the amendments and the update on the RTOG web site at http://www.rtog.org/members/protocols/0841/summary_changes.html Sites can download a copy of the protocol for IRB review at http://www.rtog.org/members/protocols/0841/0841.pdf Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. Given the extent of the changes to the protocol, Full Board Review is required. All previous IRB approvals will be expired. NCI policy requires that the "Version Date" of the protocol title page reflect the date that the amendment was submitted by RTOG to NCI. For clarity, the broadcast date of the amendment 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. Please notify your affiliates that are not on e-mail. DATE: July 1, 2010 SUBJECT: RTOG 0539, Amended and Updated Amended and Updated RTOG 0539, "Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas" Amendment 1: Use of protons was added; other clarifications and corrections were made throughout. Update: Sub-section numbering was corrected in various places. Sites can access the summaries of changes for the amendment and update at http://www.rtog.org/members/protocols/0539/summary_changes.html Sites can download a copy of the protocol for IRB review by accessing the RTOG web site http://www.rtog.org/members/protocols/0539/0539.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 of the amendment 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 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. 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: July 1, 2010 SUBJECT: Biospecimen Resource holiday hours The RTOG Biospecimen Resource Office will be closed on Monday July 5th in observance of the July 4th Holiday. We will reopen on Tuesday, July 6th at 8:30 a.m. PST. Kit requests can be made by email to RTOG@ucsf.edu, Have a Happy July 4th! DATE: July 1, 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 & CCI-779, AE-1249518, Protocol 8233, -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. DATE: June 30, 2010 SUBJECT: RTOG (0518) & 0517 PROTOCOL NOTICE: NOVARTIS SAFETY REPORT FOR ZOMETA RTOG has received safety report with from Novartis for ZOMETA The Following RTOG studies 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" The safety report(s) are sent automatically to the sites that have patients enrolled in the study. 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. - Investigator Notification PHH02010DE05808 6-25-10.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. DATE: June 30, 2010 SUBJECT: Form Revision Notice - RTOG 0436 RTOG # 436 Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients with Esophageal Cancer Treated Without Surgery 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/0436/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    I1c     06-30-10 TF Treatment Summary Form    TFa     06-30-10   Changes Made: I1: Q#16 Platelet result changed to accommodate 6 digits. TF: Q4B added. Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions received after July 15, 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: June 30, 2010 SUBJECT: RTOG Study Terminations RTOG Study Terminations As previously broadcast on June 16th, the RTOG studies included on the attached list are completed and will be terminated as of 5:00 p.m. EST today, June 30, 2010. At that time, all study activity and data collection will cease, and institutions will notify their IRBs/REBs of the terminations. Any data received at RTOG Headquarters after close of business day June 30, 2010 will be returned to the submitting institution. Please notify your affiliates that are not on e-mail. - RTOG 2010 Final List Follow-Up Termination.pdf DATE: June 29, 2010 SUBJECT: RTOG 0920 June 2010 Newsletter Hello: Welcome to the newsletter for RTOG 0920. This newsletter will broadcast bi-monthly and will keep you informed of important study issues. Regards, Treena - RTOG 0920 June 2010 Newsletter.pdf DATE: June 29, 2010 SUBJECT: RTOG 0514, Closure Notice Closure Notice RTOG 0514, "Establishment of a Head and Neck Tissue/Specimen Repository", will close to patient accrual at 5 PM EST, Tuesday, July 13th, as the study has met its objectives. Note: When RTOG 0514 is closed, sites will submit specimens according to the instructions in each RTOG head and neck protocol. Please notify your affiliates that are not on e-mail. DATE: June 28, 2010 SUBJECT: Forms Now Available for RTOG 0929 The forms are now available for RTOG 0929 "A Randomized Phase I/II Study of ABT-888 in Combination With Temozolomide in Recurrent (Temozolomide Resistant) Glioblastoma" They are available at http://www.rtog.org/members/forms/0929/main.html DATE: June 28, 2010 SUBJECT: RTOG Registration Desk closure for July 4th holiday The RTOG Registration Desk will close at 3 p.m. EST on Friday, July 2nd, and will remain closed on Monday, July 5th, for the July 4th holiday. The Registration Desk will reopen on Tuesday, July 6th 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://clinicalweb1.phila.acr.org/ClinicalRtog/faces/jsp/index.jsp Please notify your affiliates that are not on e-mail. DATE: June 25, 2010 SUBJECT: RTOG 0929, Activated Activated RTOG 0929, "A Randomized Phase I/II Study of ABT-888 in Combination With Temozolomide in Recurrent (Temozolomide Resistant) 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/0929/0929.pdf Forms for this study will be available shortly; a broadcast will be sent at that time. 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. DATE: June 25, 2010 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. 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 - Dasatinib (BMS-354825), AE 1640686, Protocol RTOG-0627, -FU1.pdf Please notify your affiliates that are not on e-mail. DATE: June 24, 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, -FU1.pdf - Bevacizumab CCI-779, AE-1981052, 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. DATE: June 24, 2010 SUBJECT: RTOG eNews: Walter J. Curran, Jr., MD, Re-elected as RTOG Group Chair Walter J. Curran, Jr., MD, was elected to a fourth four-year term as group chair at the RTOG semiannual meeting by the group's Full Member principal investigators. Curran, who has held the group chair position since 1997 is the executive director of the Winship Cancer Institute of Emory University in Atlanta, Georgia. As group chair, Curran is the principal investigator of the six-year $60.5M RTOG cooperative group grant from the NCI and is chair of the group's executive and steering committees. According to the Blue Ridge Institute for Medical Research, Curran ranks 32nd overall among all individual recipients of National Institute of Health grant awards in 2009. "I am honored and humbled to be re-elected by my peers to this important position," said Curran. "For over 40 years RTOG has set the standard for radiation therapy-related clinical and translational research both in the United States and internationally. As group chair I will continue to work with our member investigators to develop effective strategies for testing novel radiation techniques that, either alone or in combination with pharmacologic agents, improve the survival and quality of life of men and women diagnosed with cancer." DATE: June 22, 2010 SUBJECT: RTOG 0436, Updated for OPEN Updated RTOG 0436, "A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients with Esophageal Cancer Who Are Treated Without Surgery", was updated for implementation of CTSU's Oncology Patient Enrollment Network (OPEN), the web-based registration system for patient enrollments onto NCI-sponsored cooperative group clinical trials. OPEN provides the ability to enroll patients on a 24/7 basis. Note: As previously broadcast, RTOG 0436 will be the first RTOG study to use the CTSU OPEN registration for patient enrollment. Effective 8:30 a.m. EST, Wednesday, June 23rd, the RTOG web registration system for RTOG 0436 will no longer be available and when accessed, will direct sites to the OPEN registration link. To access OPEN you must have: a current CTEP-IAM account Be aligned with an institution on an organization roster in RSS (CTSU roster, Cooperative Group roster, or other network roster) For more information on OPEN please visit the CTSU member site. Sites can access the complete summary of changes for the 0436 update at http://www.rtog.org/members/protocols/0436/summary_changes.html Sites can download a copy of the updated protocol by accessing the RTOG web site at http://www.rtog.org/members/protocols/0436/0436.pdf The "Update Date" on the protocol title page indicates that editorial/administrative changes were made to the protocol. IRB review of an update is not required; however, these changes must be reported to site IRBs. Please notify your affiliates that are not on e-mail. DATE: June 22, 2010 SUBJECT: AdEERS and CDS Web Downtime this Weekend Please see the e-mail below regarding downtime for these systems: -----Original Message----- From: CTEP Adverse Event Listserv [mailto:ADEERS@LIST.NIH.GOV] On Behalf Of Finnigan, Shanda (NIH/NCI) [E] Sent: Monday, June 21, 2010 3:05 PM To: ADEERS@LIST.NIH.GOV Subject: [CTEP_AE_LISTSERV] AdEERS and CDS Web Downtime this Weekend Importance: High This is a notice of impending downtime for both the AdEERS system and the CDS Web system: - CDS Web will be taken down the evening of Friday June 25, 2010 and will remain off-line until early Sunday morning. - AdEERS will be taken down Saturday June 26, 2010 starting at 6:30pm (EDT) and will remain off-line for up to eight hours. Please hold all AdEERS reports until the system is back on-line. During this downtime, CTEP will be converting our remaining CTC v2.0 protocols to CTCAE v4.0. This conversion will result in the retirement of CTC v2.0 in the CTEP Enterprise Databases. Shanda Finnigan, RN, BSN, CCRC Operations and Informatics Branch NCI, DCTD, CTEP DATE: June 22, 2010 SUBJECT: Password Policy Change for RTOG Web Data Entry Beginning Saturday, 6/19 there will be a new policy regarding passwords. This policy will be expanded to include both internal and external applications including all Web Data Entry applications. This change includes requirements that the password be at least 8 characters long, that it contain characters and numbers and that it be changed every 90 days. You'll see this change the first time you log-in after Saturday. At that point you'll be prompted to change your password and when you do it'll have to conform to this policy: Password must be at least 8 characters. Password must have at least 1 alpha character. Password must have at least 1 numeric character. User passwords must be unique relative to the previous eight passwords used. Passwords shall be valid for no more than 90 days and no less than 30 days. People accessing the Web data entry sites will immediately be prompted to click the Change Password button. When they do they will enter their current ID and password along with a new "conforming" password. Please see example below: Default Password Message. After the implementation of Password policy all accounts will be reset. Users will be prompted with the default password message as shown below. "Your Default Password must be changed before logon to the system." DATE: June 21, 2010 SUBJECT: RTOG 0617/NCCTG N0628/CALGB 30609/ECOG R0617: Request for blood and tissue specimens Request to Investigators participating in 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" : Per Section 10.5.4.2 of the protocol, 20 ml peripheral blood (one 10 ml EDTA tube and one 10ml Red-top tube) taken from each patient before treatment, four weeks after initiation of treatment, and the first follow-up visit after completion of concurrent chemoradiotherapy is requested for banking for translation research (highly recommended, not required). The Study Chairs of RTOG 0617 strongly encourage investigators with patients enrolled on study to submit these blood specimens. If the pre-treatment blood draw was missed, please submit the 4 weeks after start of treatment and follow-up specimens so that these specimens are available for important future translation research. The Chairs also would like to strongly encourage investigators to submit tumor tissue from enrolled patients, either as a punched-out core or block, to the RTOG Biospecimen Resource, if this has already not been submitted. The RTOG Biospecimen Resource will provide the necessary kit for obtaining tissue core from tumor blocks. For questions and to request tissue/blood kits: 415-476-RTOG (7864)/FAX 415-476-5271; RTOG@ucsf.edu We appreciate your assistance and cooperation. Please notify your affiliates that are not on e-mail. DATE: June 21, 2010 SUBJECT: RTOG 0848, Amended and Updated: protocol cover page date correction Attention RTOG 0848 Investigators and Research Associates: The cover page for the amended/updated protocol for RTOG 0848 (broadcast date 6/17/10) inadvertently included the former update date (11/17/09) in place of the current update date (6/17/10). The update date has been corrected on the protocol cover page. The protocol is available at http://www.rtog.org/members/protocols/0848/0848.pdf ________________________________________ From: RTOGBroadcast Sent: Thursday, June 17, 2010 10:56 AM To: RTOGBroadcast Cc: RTOGBroadcast Subject: RTOG 0848, Amended and Updated Amended and Updated RTOG 0848, "A Phase III Trial Evaluating Both Erlotinib and Chemoradiation as Adjuvant Treatment for Patients with Resected Head of Pancreas Adenocarcinoma" Amendment 2: In response to a request for an amendment (RA) from CTEP, the protocol was amended to reflect a revised CAEPR for erlotinib. In addition, various clarifications and corrections were made. Update: The protocol was reformatted to current RTOG standard, and numbering for the Eligibility Checklist was corrected. Sites can access the summaries of changes for the amendment and update at http://www.rtog.org/members/protocols/0848/summary_changes.html Sites can download a copy of the protocol for IRB review by accessing the RTOG web site http://www.rtog.org/members/protocols/0848/0848.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 of the amendment 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 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. 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: June 17, 2010 SUBJECT: RTOG 0227, Action Letter & Study Closure at 5PM EST Today Action Letter and Study Closure RTOG 0227, "Phase I/II Study of Pre-Irradiation Chemotherapy With Methotrexate, Rituximab, and Temozolomide and Post-Irradiation Temozolomide for Primary Central Nervous System Lymphoma" RTOG has received an ACTION LETTER from NCI/NIH for rituximab (NSC 687451, IND 7028). Accrual of new patients to RTOG 0227 is SUSPENDED per NCI guidelines. Because permanent closure to this study was planned for June 25, as broadcast on June 11, the study will instead permanently close to accrual as of 5pm EST, Thursday, June 17, 2010. Patients currently on study may continue on study provided they are informed of the new risks identified as part of the CAEPR update in the Action Letter. Per CTEP's policy for trials with a CTEP status of "Closed to Accrual," RTOG will not issue an amendment to this protocol for site IRB approval. However, all sites should follow local IRB or Operations Office procedures and requirements. Please notify your affiliates that are not on e-mail. - Action Letter_Rituximab_NSC 687451_IND 7028_June 16, 2010.pdf DATE: June 17, 2010 SUBJECT: RTOG 0848, Amended and Updated Amended and Updated RTOG 0848, "A Phase III Trial Evaluating Both Erlotinib and Chemoradiation as Adjuvant Treatment for Patients with Resected Head of Pancreas Adenocarcinoma" Amendment 2: In response to a request for an amendment (RA) from CTEP, the protocol was amended to reflect a revised CAEPR for erlotinib. In addition, various clarifications and corrections were made. Update: The protocol was reformatted to current RTOG standard, and numbering for the Eligibility Checklist was corrected. Sites can access the summaries of changes for the amendment and update at http://www.rtog.org/members/protocols/0848/summary_changes.html Sites can download a copy of the protocol for IRB review by accessing the RTOG web site http://www.rtog.org/members/protocols/0848/0848.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 of the amendment 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 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. 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: June 16, 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. 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. - IMC-A12 OSI-774, AE-1398066, Protocol S0727, ISR.PDF - IMC-A12 OSI-774, AE-1559936, Protocol S0727, -FU1.pdf - IMC-A12 OSI-774, AE-1203166, Protocol S0727.pdf DATE: June 16, 2010 SUBJECT: RTOG Study Terminations RTOG Study Terminations The following studies (see attached list) are completed and will be terminated as of June 30, 2010. As of that date all study activity and data collection will cease, and institutions should notify their IRBs/REBs of the terminations. Any data received at RTOG Headquarters after June 30, 2010 will be returned to the submitting institution. Please notify your affiliates that are not on e-mail. - RTOG 2010 Final List Follow-Up Termination.pdf DATE: June 15, 2010 SUBJECT: RTOG Semiannual Meeting Symposium Please join us for the Comparative Effectiveness Research Symposium Loews Hotel Philadelphia, Regency AB Friday, June 18, 2010 8:30 am - 11:00 am Moderators Justin E. Bekelman, MD, Hospital of the University of Pennsylvania Deborah Watkins Bruner, RN, PhD, University of Pennsylvania School of Nursing Walter J. Curran, Jr., MD, RTOG Group Chair, Winship Cancer Institute of Emory KEYNOTE ADDRESS Comparative Effectiveness Research: Challenges and Opportunities J. Sanford Schwartz, MD Professor of Medicine, Health Care Management, and Economics Wharton School, University of Pensylvania The Complete And Unabridged History Of Comparative Effectiveness Research In The Radiation Therapy Oncology Group Andre Konski, MD, MBA, MA, FACR Professor and Chair, Department of Radiation Oncology Wayne State University School of Medicine Intersection of Comparative Effectiveness and Personalized Medicine: Implications for Radiation Oncology (I) Justin E. Bekelman, MD Assistant Professor, Department of Radiation Oncology Hospital of the University of Pennsylvania Intersection Of Comparative Effectiveness And Personalized Medicine: Implications For Radiation Oncology (II) Jason A. Efstathiou, MD, DPHIL Assistant Professor of Radiation Oncology Massachusetts General Hospital, Harvard Medical School Comparative Effectiveness Research in Cooperative Groups: Methods and Areas of Opportunity James J. Dignam, PhD Group Statistician, Radiation Therapy Oncology Group Associate Professor of Biostatistics, University of Chicago *agenda available at www.rtog.org under "Meeting", or at http://www.rtog.org/meeting/Meeting Materials Jun10_Symposium4.pdf DATE: June 15, 2010 SUBJECT: RTOG Semiannual Meeting Webinars Can't attend the semiannual meeting? Sign-up for Webinars RTOG will host two Webinars during the semiannual meeting: RA Scientific Session, Friday, June 18th, 1:00 - 3:00 PM ET HSRO and Symptom Management Committee, Saturday, June 19th, 10:00 AM - 12:00 PM ET Advanced registration is required. Please visit the Web site below to sign-up. https://www.signup4.net/public/ap.aspx?EID=RTOG12E&OID=130 Please contact Michelle Buado (mbuado@acr-arrs.org, 215-574-3224) if you need more information about the semiannual meeting. DATE: June 15, 2010 SUBJECT: RTOG Meeting Translational Research Program Session RTOG Semiannual Meeting Translational Research Program Speakers At the TRP session (Saturday, 11-2, Regency A) we are excited to have 3 great speakers whose research can have significant impact on our mission! Dr. Isidore Rigoutsos-"Von Neumann meets Sanger: toward novel diagnostics and therapeutics". Dr. Rigoutsos joined Thomas Jefferson University after nearly 18 years with IBM's Thomas J. Watson Research Center, where he founded and managed the Bioinformatics and Pattern Discovery group. Dr. Rigoutsos' involvement in the field of Computational Biology spans the last nearly two decades. During this time, he has been developing computer algorithms for studying genomic phenomena and analyzing very large biological datasets. He has authored or co-authored nearly 90 peer-reviewed journal and conference publications and is inventor or co-inventor on 17 US Patents. In 2006, Dr. Rigoutsos edited a two-volume book on "Systems Biology" that was published by Oxford University Press. For the last 14 years, his efforts have revolved around the theoretical and practical aspects of pattern discovery and the design of pattern-based solutions to a variety of problems from computational biology including drug design, gene discovery, automated protein annotation, the study of lateral gene transfer, the design of antimicrobial peptides, etc. Starting in 2002, Dr. Rigoutsos' focus has been on non-coding RNAs (in particular microRNAs and piRNAs), the discovery of the targets of such non-coding RNAs, the discovery of novel, organism-specific regulatory sequences, and the study of potential applications of RNA/RNA and RNA/DNA interactions in regenerative medicine and therapy. Dr. Ulrich Rodeck- "Novel approaches to mitigate skin toxicity by EGFR inhibitors", Thomas Jefferson University. Dr. Rodeck has published extensively on epithelial cell survival controlled by EGFR, therapeutic antibodies in cancer and antibody engineering, and molecular mechanisms of adverse events caused by cancer therapy. Dr. Zhongxing Liao, "SNPs as biomarker to guide personalized radiation therapy for lung cancer", MD Anderson Cancer Center, Dr. Liao is an expert in the treatment of lung cancer with targeted agents and particle therapy. DATE: June 14, 2010 SUBJECT: Important Reminder - CTSU Oncology Patient Enrollment Network (OPEN) is coming soon to RTOG! Important Reminder - On June 23, 2010 sites participating in RTOG 0436 will begin using the CTSU OPEN registration system for patient enrollment. The RTOG web registration system for RTOG 0436 will no longer be available. Please note to access OPEN Site staff will need to be registered with CTEP and have a valid and active CTEP-IAM account. This is the same account (user id and password) used for the CTSU members' web site. Be aligned with an institution on an organization roster in RSS (CTSU roster, Cooperative Group roster, or other network roster) . Questions to ask: . Is your RTOG group roster up-to-date? If not, please send your updated roster to RTOG_Membership@acr-arrs.org. Is your CTSU RSS roster up-to-date? Make sure that all physicians who will be enrolling patients on RTOG 0436 and all staff who will be registering patients through OPEN are listed as a participant in the appropriate cooperative group through the CTSU/RSS Web site. Other RTOG studies are currently being assessed and will be added to the CTSU OPEN registration system shortly. We will announce each study prior to implementation. Stay Tuned! For more information on OPEN please visit the CTSU member site. DATE: June 11, 2010 SUBJECT: RTOG 0227, Closure Notice Closure Notice RTOG 0227, "Phase I/II Study of Pre-Irradiation Chemotherapy With Methotrexate, Rituximab, and Temozolomide and Post-Irradiation Temozolomide for Primary Central Nervous System Lymphoma," will close to patient accrual at 5 PM EST, Friday, June 25, because the study has met its accrual objective. Please notify your affiliates that are not on e-mail. DATE: June 11, 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-1996104, Protocol GOG-0218, -FU1.pdf - Bevacizumab, AE-1190366, Protocol GOG-0252, -ISR.PDF - Bevacizumab CCI-779, AE-1448075, Protocol GOG-0229G, -FU1.pdf DATE: June 10, 2010 SUBJECT: Form Revision Notice - RTOG 0920 RTOG #0920 A PHASE III STUDY OF POSTOPERATIVE RADIATION THERAPY (IMRT) +/- CETUXIMAB FOR LOCALLY-ADVANCED RESECTED HEAD AND NECK 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/0920/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 FACT-HN    FAa     06/07/10 DL DLQI    DLa     06/07/10 L4 Xe-QOLS    L4a     06/07/10 HP EQ-5D    HPa     06/07/10   Changes: FA, HP & L4 Forms Question #1 Timepoint: Added choice 4) 2 years from start of treatment DL Form Question #1 Timepoint: Changed choices 2) 3 months from start of treatment, 3) 1 year from start of treatment Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions received after June 25, 2010 will be returned to the site for transcription. The following forms are currently available for web data submission FA, DL & L4 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-Rueter, BA, CCRP RTOG Data Management DATE: June 10, 2010 SUBJECT: RTOG eNews: RTOG 0129 HPV Analysis Reported in NEJM RTOG eNews June 10, 2010 RTOG HPV Analyses in NEJM and at ASCO: Presence of HPV Predicts Survival for Oropharyngeal Cancer Patients Oropharyngeal cancer patients whose tumors test positive for the human papillomavirus (HPV) live longer after treatment than patients whose tumors test negative according to research from the Radiation Therapy Oncology Group (RTOG) published online in the New England Journal of Medicine (NEJM) and presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. RTOG researchers led by K. Kian Ang, M.D., Ph.D. of the University of Texas M.D. Anderson Cancer Center, who is the lead author of the study published in the NEJM, and Maura L. Gillison, M.D., Ph.D. of The Ohio State University, who directed the HPV analysis, found that oropharyngeal cancer patients with HPV-positive tumors had a survival rate 25 percentage points higher at three years (82.4% vs. 57.1%) than patients on the study with HPV-negative tumors. This survival benefit was seen irrespective of the assigned cancer treatment and traditional prognostic factors such as tumor stage and age. The researchers also found that tobacco smoking was independently associated with survival for both groups of patients and the risk of death and cancer progression increased by 1% for each pack-year of tobacco smoking. Dr. Gillison reports that, "Our data reveal that the biologic behavior of an HPV-positive tumor may be altered by tobacco use. It appears that genetic alterations induced by tobacco-associated carcinogens may make HPV-positive tumors less responsive to cancer therapy. Our data show that as the pack-years for tobacco smoking increased survival decreased." The published results are based on an analysis of study data from RTOG 0129, a prospective randomized phase III trial evaluating the value of accelerated radiotherapy combined with cisplatin chemotherapy as compared to cisplatin and standard radiotherapy for patients with stage III-IV head and neck cancer. Utilizing specimens collected at the time of patient entry into the study, the investigators were able to complete a retrospective analysis of the HPV status of the oropharyngeal tumors based on in-situ hybridization. Using a recursive partitioning analysis the researchers were able to classify the patients as having a low, intermediate, or high risk of death based on four factors: HPV status, pack-years of tobacco smoking, tumor stage, and nodal stage. Study data presented at ASCO on a second study, RTOG 9003, confirms the correlation of HPV status (via its surrogate, p16) and pack-years of tobacco smoking to survival. In this study of 1068 head and neck patients enrolled over seven years to a randomized phase III trial evaluating four different radiotherapy schedules, 60% had oropharynx cancer and HPV status was able to be determined for 29% (190) of those patients. Once again the investigators found that HPV status and tobacco pack-years were independent predictors of patient survival. According to Dr. Ang, "On the basis of our data, we believe that future clinical trials, and indeed future treatment decisions, should be designed on the basis of the patient's HPV status as it may be possible to achieve good survival rates for HPV-positive patients without the long-term complications of intensive multi-modality therapy." HPV status has been correlated with survival in other smaller studies but this is the first analysis of a patient cohort of sufficient size to show the correlation irrespective of treatment and other favorable prognostic factors. "RTOG has been a leader in head and neck cancer research since the 1970's. Our unique database of outcome results and biospecimen resources allow us to quickly test and validate new hypotheses in biomarker research," said Walter J. Curran, Jr., M.D., the RTOG Group Chair, and the Executive Director of the Winship Cancer Institute of Emory University. "This type of research exemplifies the value of the NCI-funded cancer cooperative groups in answering questions that need rigorously collected multicenter data." # # # New England Journal of Medicine: Human Papillomavirus and Survival of Patients with Oropharyngeal Cancer [Authors: K. Kian Ang, M.D., Ph.D., Jonathan Harris, M.S., Richard Wheeler, M.D., Randal Weber, M.D., David I. Rosenthal, M.D., Phuc Felix Nguyen-Tân, M.D., William H. Westra, M.D., Christine H. Chung, M.D., Richard C. Jordan, D.D.S., Ph.D., Charles Lu, M.D.{Q2}, Harold Kim, M.D., Rita Axelrod, M.D., C. Craig Silverman, M.D., Kevin P. Redmond, M.D., and and Maura L. Gillison, M.D., Ph.D. ] This article (10.1056/NEJMoa0912217) was published on June 7, 2010, at NEJM.org. ASCO Abstract # 5510: Analysis of the effect of p16 and tobacco pack-years (p-y) on overall (OS) and progression-free survival (PFS) for patients with oropharynx cancer (OPC) in Radiation Therapy Oncology Group (RTOG) protocol 9003 [Authors: M. L. Gillison, Q. Zhang, K. Ang, K. K. Fu, M. E. Hammond, R. Jordan, A. Trotti, S. Spencer, M. Rotman, C. H. Chung; The Ohio State University, Columbus, OH; RTOG Statistical Center, Philadelphia, PA; University of Texas M. D. Anderson Cancer Center, Houston, TX; University of California, San Francisco, San Francisco, CA; LDS Hospital, Salt Lake, UT; H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL; University of Alabama at Birmingham, Birmingham, AL; SUNY Health Science Center, Brooklyn, NY; Vanderbilt University, Nashville, TN] is available at http://abstract.asco.org/AbstView_74_42843.html. ASCO Abstract #5507: A phase III trial (RTOG 0129) of two radiation-cisplatin regimens for head and neck carcinomas (HNC): Impact of radiation and cisplatin intensity on outcome [Authors: K. Ang, Q. Zhang, R. H. Wheeler, D. I. Rosenthal, F. Nguyen-Tan, H. Kim, C. Lu, R. S. Axelrod, C. I. Silverman, R. S. Weber; University of Texas M. D. Anderson Cancer Center, Houston, TX; RTOG Statistical Center, Philadelphia, PA; Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Centre Hospitalier de I'Universite de Montreal, Montreal, QC, Canada; Karmanos Cancer Institute, Wayne State University, Detroit, MI; Thomas Jefferson University, Philadelphia, PA; University of Louisville, Louisville, KY], is available at http://abstract.asco.org/AbstView_74_41254.html. DATE: June 8, 2010 SUBJECT: RTOG 0524, Amended Amended 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" Amendment 5: In response to a request for an amendment (RA) from CTEP, the protocol was amended to reflect changes to the Comprehensive Adverse Events and Potential Risks List (CAEPR) for Trastuzumab. Please Note: Although the revised CAEPR reflects the CTCAE migration from version 3.0 to 4.0 terminology, there is no new or modified risk information for trastuzumab other than what is outlined in the summary of changes. Sites can access the summary of changes for the amendment 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 http://www.rtog.org/members/protocols/0524/0524.pdf http://www.rtog.org/members/protocols/0627/0627.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 of the amendment 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. 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: June 8, 2010 SUBJECT: Shipping of Biospecimen Collection Kits to Sites Please note new procedures for shipping of biospecimen kits: Shipping of Biospecimen Collection Kits to Sites Kits will now be shipped to sites using Fed Ex Ground. Sites will receive kits 7-10 days after a request is received. Please notify us if a kit is needed sooner. We will then ship by Fed Ex 3 day Express. Requests for us to ship kits overnight by priority Fed Ex must include a Fed Ex account to charge to. We can no longer cover the cost of such last minute kit requests. Shipping of Frozen Biospecimens to RTOG All Frozen Biospecimen shipments being sent to RTOG must have the below address associated with them, and should ONLY be shipped Monday- Wednesday (Monday and Tuesday for Canadian sites) FedEx/Courier address RTOG Biospecimen Resource UCSF 1657 Scott Street, Room 223 San Francisco, CA 94115 Contact phone: 415.476.7864 Please note that RTOG will only pay for incoming shipments that have used our pre-paid labels which have unique reference numbers on them. We can email you labels if you need them the same day; just send us an email at RTOG@ucsf.edu. Canadian sites can request a one time Reference Number to use for each shipment. Any site that uses our account number without a reference number provided by us will be billed for their shipment. Please email RTOG@ucsf.edu with questions. We will be at the CRA round table session on Friday June 17th at 8 am in Philadelphia. Thank you. DATE: June 8, 2010 SUBJECT: Form Revision Notice - RTOG 0631 RTOG#0631 PHASE II/III STUDY OF IMAGE-GUIDED RADIOSURGERY/SBRT FOR LOCALIZED SPINE METASTASIS 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=0631/0631i1.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     4/27/10   Changes Made: Q#6-added "Not applicable" to the code table Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions received after June 14, 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, CCRP RTOG Data Management DATE: June 4, 2010 SUBJECT: RTOG Meeting Semiannual meeting online Registration & Hotel Reservation deadline is today! June 4, 2010 RTOG Members: The RTOG Meeting Semiannual meeting will be held in Philadelphia, PA from June 17 - 20, 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. To guarantee the room rate of $208/night plus tax, your hotel reservation must be made by June 4th, 2010th. Registration for the meeting must be received by 4:00pm EST on Friday, June 4th, 2010. Your preregistration is necessary to ensure that the appropriate amounts of resources are 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 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 Clinical Trail Administration DATE: June 4, 2010 SUBJECT: RTOG 1014, Activated Activated RTOG 1014, "A Phase II Study of Repeat Breast Preserving Surgery and 3D-Conformal Partial Breast Re-Irradiation (PBrI) for Local Recurrence of Breast Carcinoma" Institutions can download a copy of the protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/protocols/1014/1014.pdf Forms for this study can be accessed on the RTOG web site at http://www.rtog.org/members/forms/1014/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. DATE: June 3, 2010 SUBJECT: New Process to Request Early Study Closure with IRB RTOG is excited to announce the implementation of a new process, which will significantly relieve some of the regulatory burden for site research staff and their IRBs related to RTOG led studies. The internal RTOG process will involve multi department review and approval. This broadcast is intended to: Define the criteria Introduce the associated form Describe the process Outline form submission requirements Outline response expectations (Please see the attachments for details) IMPORTANT NOTE: Full member institutions that have affiliates that use the Full Member IRB as their IRB of record must ensure that any and all affiliates/Joint Center institutions have also met the criteria selected. If they have not, the IRB must keep this study open for annual/continuing review until all institutions operating under that review have met the criteria. The attached form, which is also available on the forms page under Regulatory on the RTOG website at http://www.rtog.org/members/forms/list.html, must be completed and submitted according to the instructions on the form. The normal formal response time is expected to be 10-14 business days but due to the expectation of numerous submissions during the initial implementation phase, the predicted initial response time is 21-28 business days. - Broadcast Attachment.pdf - Request for Study Closure with Site IRB or transfer of IRB Responsibility [FINAL 5-27-10].doc DATE: June 3, 2010 SUBJECT: RTOG Meeting Announcement-CogState Computerized Neurocognitive Testing Software to be Introduced at the RTOG Semi-Annual Meeting Special Interest Announcement: CogState Computerized Neurocognitive Testing Software to be Introduced at the RTOG Semi-Annual Meeting The RTOG is seeking to incorporate the next generation of computerized neurocognitive testing into future RTOG brain tumor trials. We have chosen to partner with CogState, a global provider of cognitive testing products and services. Join us as we discuss in detail the CogState neurocognitive test battery in two 30 minute sessions at the RTOG semi-annual meeting in Philadelphia. Date: Thursday June 17th Times: 4:30-5:00 PM : Introduction to CogState Computerized Neurocognitive Testing (for Site Investigators) This session is targeted towards RTOG site investigators and will provide an introduction to the CogState software and an overview of the advantages offered by CogState. This discussion will include a brief overview of upcoming RTOG trials in which CogState will be utilized: RTOG 0933 (hippocampal avoidance during WBRT) and RTOG 0925 (natural history of cognitive function in low-grade gliomas). 5:00-5:30 PM: Training in the administration of CogState Neurocognitive Testing (for Research Associates and Site Investigators) This session is targeted towards RTOG Research Associates and Site Investigators and will offer a preliminary training in the administration of the CogState neurocognitive testing battery. Location: Commonwealth A We hope to see you there DATE: June 3, 2010 SUBJECT: RTOG 0127/ECOG 5597: Amended Amended RTOG 0127/ECOG E5597, "Phase III Chemoprevention Trial of Selenium Supplementation in Persons with Resected Stage I Non-Small Cell Lung Cancer", (a closed study): ECOG has amended the protocol with Addendum #8. RTOG sites can access this addendum via a link to ECOG's web site, http://www.ecog.org/rtog/ (User name: rtog and Password: igprot). On ECOG's web site, scroll down to ECOG 5597. 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: June 1, 2010 SUBJECT: RTOG Meeting Hotel Reservations Extended & Webinar Sign-up Make Your RTOG Semiannual Meeting Reservations Now! The RTOG semiannual meeting will be held June 17-20, 2010 at the Loews Philadelphia Hotel. The online meeting registration portal is available at (https://registrations.acr.org/rtog/) and 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/. The cut-off date for making reservations at the Loews Philadelphia Hotel has been extended until June 4, 2010. After that date you will no longer be able to receive the discounted meeting rate. When making your reservation, please reference the RTOG Semiannual Meeting to ensure that you receive the RTOG group rate. Can't attend the semiannual meeting? Sign-up for Webinars. RTOG will host two Webinars during the semiannual meeting: RA Scientific Session, Friday, June 18th, 1:00 - 3:00 PM ET HSRO and Symptom Management Committee, Saturday, June 19th, 10:00 AM - 12:00 PM ET Advanced registration is required. Please visit the Web site below to sign-up. https://www.signup4.net/public/ap.aspx?EID=RTOG12E&OID=130 DATE: June 1, 2010 SUBJECT: RTOG 0320, Updated CAEPR for Erlotinib (OSI-774), NSC 718781, IND 63383 ATTN: RTOG 0320 Principal Investigators and Program Coordinators RE: 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" Please see the attached update to the Erlotinib (NSC 718781, IND 63383) Comprehensive Adverse Events and Potential Risks (CAEPR v2.3) and Risk Profile. CTEP has updated the CAEPR and Risk Profile as part of its routine assessment of agent risks. Although there is modified risk information for erlotinib, no new risks have been added to the Risk Profile. Per CTEP's policy for trials with a current CTEP status of "Closed to Accrual," an amendment is not required. RTOG will therefore not issue an amendment to this protocol, and this information is being sent for informational purposes only. However, all sites should follow local IRB or Operations Office procedures and requirements. - Risk List_erlotinib_NSC 718781_v 2 3_3-29-10.doc - CAEPR_erlotinib_NSC 718781_v 2 3_3-29-10.pdf DATE: May 28, 2010 SUBJECT: RTOG 0539 May 2010 Newsletter Attached is the May 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: Comments From the Chair: Central Radiology Review Form Enrollment Kathryn Okrent Protocol Associate, Brain Trials Radiation Therapy Oncology Group Tel: 215-717-0856 Fax: 215-940-8809 kokrent@acr-arrs.org - 0539 May 2010 Newsletter.pdf DATE: May 28, 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 CCI-779, AE-1367114, Protocol 8233, -ISR.PDF DATE: May 27, 2010 SUBJECT: Protocol Notice: RTOG 0436, 0521,0525 0617,0619, 0831, 0834,0920 DRUG Distributor Biologics Holiday Closure Notice Biologics Clinical Trial Services is closed Monday, May 31, 2010, for the Memorial Day holiday. We will resume regular business hours on Tuesday, June 1. 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. Karl Buer Manager, Sales and Operations Kbuer@biologicstoday.com Ext. 4991 DATE: May 27, 2010 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0436 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 Web-Based Electronic Data Submission is now available for the following 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 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 6/4/10 will be returned to the site for web submission. Please notify your joint center institutions and affiliates who are not on e-mail. Wendy Bergantz, RN RTOG Data Management DATE: May 27, 2010 SUBJECT: RTOG Registration Desk Early closure Tomorrow, 5/28/10 and all day Monday 5/31/10 The RTOG Registration Desk will be close early tomorrow, Friday, May 28th from 3--5 p.m. EST. in anticipation of the Memorial Day Holiday. The office will also be closed all day Monday, May 31st, 8:30 a.m.-5 p.m. EST in celebration of the Memorial Day Holiday. 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 On behalf of the RTOG, we would like to wish you all a safe and happy holiday weekend! Please notify your affiliates that are not on e-mail. DATE: May 27, 2010 SUBJECT: RTOG 0436 APRIL/MAY 2010 NEWSLETTER Hello: Attached please find the 0436 Newsletter for the months of April and May 2010. Regards, Treena - RTOG 0436 Newsletter APRIL & MAY 2010.pdf DATE: May 27, 2010 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0617 RTOG 0617/NCCTG N0628/CALGB 30609 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 Web-Based Electronic Data Submission is now available for the following 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 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 6/4/10 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: May 27, 2010 SUBJECT: RTOG 0834 (CANTON Trial), Pre-Randomization Guidelines Attention Investigators With Potential Patients for 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 CATON Intergroup Trial:" To aid you in the pre-randomization enrollment process, the RTOG has prepared the following guidelines: Patients must be randomized within 6 weeks following surgery. Step 1 registration to initiate the tissue screening process should begin approximately 2 weeks post surgery, to allow sufficient time for the tissue screening process to be complete. The tissue screening process is generally expected to take between 13 and 16 days. If the patient is known to be 1p/19q co-deleted, please consider enrolling the patient in the trial's counterpart for 1p/19q co-deleted tumors, NCCTG N0577 (RTOG 1071); enrollment for RTOG sites is available via the CTSU. Please refer to the attached trial schema, extracted from the CATNON protocol, for additional schematic details. - Schema for CATNON Trial.pdf DATE: May 25, 2010 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0614 RTOG 0614 A RANDOMIZED, PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF MEMANTINE FOR PREVENTION OF COGNITIVE DYSFUNCTION IN PATIENTS RECEIVING WHOLE-BRAIN RADIOTHERAPY Web-Based Electronic Data Submission is now available for the following form: QL - Medical Outcome Scale: Cognitive 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 06/04/2010 will be returned to the site for web submission. Please notify your joint center institutions and affiliates who are not on e-mail. Sandrine Geinoz, PhD, CCRP RTOG Data Management DATE: May 24, 2010 SUBJECT: The Oncology Patient Enrollment Network (OPEN) is coming soon to RTOG! The Oncology Patient Enrollment Network (OPEN) is coming soon to RTOG! OPEN is the web-based registration system for patient enrollments onto NCI-sponsored cooperative group clinical trials. The system is integrated with the CTSU Enterprise System for regulatory and roster data, and with each of the Cooperative Groups' registration/randomization systems for patient registration/randomization. OPEN provides the ability to enroll patients on a 24/7 basis. On June 23, 2010 RTOG will begin using the CTSU OPEN registration system for patient enrollment on RTOG 0436. The RTOG web registration system for RTOG 0436 will no longer be available and when accessed will direct you to the OPEN registration link. Other RTOG studies are currently being assessed and will be added to the CTSU OPEN registration system shortly. We will announce each study prior to implementation. Please note to access OPEN you must have: a current CTEP-IAM account Be aligned with an institution on an organization roster in RSS (CTSU roster, Cooperative Group roster, or other network roster) For more information on OPEN please visit the CTSU member site. DATE: May 20, 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=0534/0534f1.pdf The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date F1b    F1c     05/19/10   Changes Made: Q#10a-allow for additional laboratory data entry. Discard obsolete versions and commence use of the revised edition immediately. Obsolete versions received after 5/28/2010 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: May 19, 2010 SUBJECT: RTOG 0848 Amendment #1: Health Canada Approval RTOG Study 0848 - “A Phase III Trial Evaluating Both Erlotinib and Chemoradiation as Adjuvant Treatment for Patients with Resected Head of Pancreas Adenocarcinoma” Regulatory Note: Prior to clinical trial commencement, there are three TPD forms that need to be completed for each site. They are as follows: Clinical Trial Site Information Form Qualified Investigator Undertaking Form Research Ethics Board Attestation Form for the current version of the protocol Each form is attached with the RTOG information included. Please complete each form and forward the packet to the Cancer Trials Support Unit (CTSU) Fax# 215-569-0206. Also, please forward your REB approval for this protocol. Should there be any REB refusals, the TPD must be notified. Once all forms have been received and reviewed at CTSU, the Clinical Trial Site Information Form will be faxed to TPD for study commencement. The No Objection Letter is also included for your convenience. Please visit the Canadian Information Section of the RTOG Website for access to these and other study related templates of required Health Canada forms for all studies involving a Health Canada CTA at the following link: http://www.rtog.org/members/CanadaInfo/main.html (Please note: 48 hours may be required for forms attached to recent broadcasts to be available on the site) If questions arise regarding this broadcast, please contact Marie D'Amico at mdamico@acr-arrs.org or 215-574-3185 or Nancy Soto at nsoto@acr-arrs.org or 215-940-8876 Please notify your affiliates who are not on this e-mail. American College of Radiology 1818 Market Street, Suite 1600 Philadelphia, PA 19103 - RTOG 0848 QIU.doc - RTOG 0848 REBA.doc - RTOG 0848 A-1.pdf - RTOG 0848 CTSI.doc DATE: May 19, 2010 SUBJECT: RTOG 0712 Amendment #1 and #2: Health Canada Approval RTOG Study 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" Regulatory Note: Prior to clinical trial commencement, there are three TPD forms that need to be completed for each site. They are as follows: Clinical Trial Site Information Form Qualified Investigator Undertaking Form Research Ethics Board Attestation Form for the current version of the protocol Each form is attached with the RTOG information included. Please complete each form and forward the packet to the Cancer Trials Support Unit (CTSU) Fax# 215-569-0206. Also, please forward your REB approval for this protocol. Should there be any REB refusals, the TPD must be notified. Once all forms have been received and reviewed at CTSU, the Clinical Trial Site Information Form will be faxed to TPD for study commencement. The No Objection Letter is also included for your convenience. Please visit the Canadian Information Section of the RTOG Website for access to these and other study related templates of required Health Canada forms for all studies involving a Health Canada CTA at the following link: http://www.rtog.org/members/CanadaInfo/main.html (Please note: 48 hours may be required for forms attached to recent broadcasts to be available on the site) If questions arise regarding this broadcast, please contact Marie D'Amico at mdamico@acr-arrs.org or 215-574-3185 or Nancy Soto at nsoto@acr-arrs.org or 215-940-8876 Please notify your affiliates who are not on this e-mail. American College of Radiology 1818 Market Street, Suite 1600 Philadelphia, PA 19103 - 0712 CTSI Form.doc - RTOG 0712 A-1 and A-2.pdf - 0712 research ethics board attestation.doc - 0712 qualified investigator undertaking.doc DATE: May 19, 2010 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 FAa    FAb     05/07/10 QLa    QLb     05/07/10 HP    HPa     05/07/10 QF    QFa     05/07/10   Changes Made: Code#1 in the code table for Q#1 is unavailable-the time point is not applicable to this study Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions received after 05/28/2010 will be returned to the site for transcription. Please notify your joint center institutions and affiliates who are not on e-mail. Roseann Bonanni, CCRP RTOG Data Management DATE: May 18, 2010 SUBJECT: RTOG eNews: RTOG Studies at ASCO 2010 Annual Meeting RTOG eNews May 18, 2010 ASCO 2010 Annual Meeting Presentations The following RTOG studies will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, June 4-8, 2010 at McCormick Place, Chicago, IL For full meeting agenda and information, you may visit the official ASCO meeting website at http://chicago2010.asco.org/Home.aspx http://www.rtog.org/pdf_file.html?abstracts=RTOG%20ASCO%202010%20Presentations.pdf DATE: May 18, 2010 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0617 RTOG 0617 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 Web-Based Electronic Data Submission is now available for the following form: FA-Functional Assessment Cancer Therapy-Lung Trial Outcome Index (TOI) 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 web support (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 May 28, 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: May 18, 2010 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 9805 RTOG 9805 PHASE II TRIAL OF TRANSRECTAL ULTRASOUND GUIDED PERMANENT RADIOACTIVE IMPLANTATION OF THE PROSTATE FOR DEFINITIVE MANAGEMENT OF LOCALIZED ADENOCARCINOMA OF THE PROSTATE Web-Based Electronic Data Submission is now available for the following form: 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 web support (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 May 28, 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: May 17, 2010 SUBJECT: RTOG 0618, Closure Notice Closure Notice RTOG 0618, "Phase II Trial of Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Patients with Operable Stage I/II Non-Small Cell Lung Cancer", will close to patient accrual at 5 PM EST today, Monday, May 17th, as the study has met its accrual objective. (Notice of this closure was broadcast on May 3, 2010.) Please notify your affiliates that are not on e-mail. DATE: May 14, 2010 SUBJECT: Make Your RTOG Semiannual Meeting Reservations Now! Make Your RTOG Semiannual Meeting Reservations Now! The RTOG semiannual meeting will be held June 17-20, 2010 at the Loews Philadelphia Hotel. The online meeting registration portal is available at (https://registrations.acr.org/rtog/) and 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. The cut-off date for making reservations at the Loews Philadelphia Hotel is May 27, 2010. When making your reservation, please reference the RTOG Semiannual Meeting to ensure that you receive the RTOG group rate. Please contact Michelle Buado (mbuado@acr-arrs.org, 215-574-3224) if you need more information about the semiannual meeting. DATE: May 14, 2010 SUBJECT: Endorsed, NCIC CTG PR.11 (RTOG 0873) The following study has been endorsed by the Radiation Therapy Oncology Group and its Genitourinary Cancer Committee: NCIC CTG PR.11 (RTOG 0873), "A Phase III Study Of Active Surveillance Therapy Against Radical Treatment In Patients Diagnosed With Favourable Risk Prostate Cancer (START)" RTOG Co-Chair: C. Richard Choo, MD, FRCPC, FACR, Mayo Clinic, 507-284-3551, Choo.C@mayo.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. All questions related to trial conduct, eligibility, treatment, CRF completion, etc., should be directed to the NCIC Clinical Trials Group. For other questions, please refer to the list of contacts page posted on the protocol specific notes page of the CTSU web site. Please notify your affiliates who are not on e-mail. DATE: May 14, 2010 SUBJECT: RTOG 0873 (NCIC CTG PR.11), Amendment #2 and Inclusion on CTSU Menu RTOG 0873 (NCIC CTG PR.11), "A Phase III Study Of Active Surveillance Therapy Against Radical Treatment In Patients Diagnosed With Favourable Risk Prostate Cancer (START)" NCIC CTG Memo: Instructions are attached regarding Amendment #2 of the protocol and inclusion on the CTSU menu. All U.S. sites must now enroll patients via the CTSU. The amended protocol and summary of changes documents are located on the CTSU website. - CTSU Activation Letter for US feasibility sites May 2010.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 CTSU menu. DATE: May 14, 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 CCI-779, AE-1220746, Protocol 8233, -ISR.PDF - Bevacizumab CCI-779, AE-1746507, Protocol 8233, -ISR.PDF - Bevacizumab CCI-779, AE-1249518, Protocol 8233, -ISR.PDF - Bevacizumab, AE-1366672, Protocol RTOG-0825, -FU1.pdf - Bevacizumab, AE-1184694, Protocol E1505, -FU1.pdf - Bevacizumab, AE-1206408, Protocol E5103, -FU1.pdf - Bevacizumab, AE-1138043, Protocol RTOG-0825, -ISR.PDF DATE: May 13, 2010 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0614 RTOG 0614 A RANDOMIZED, PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF MEMANTINE FOR PREVENTION OF COGNITIVE DYSFUNCTION IN PATIENTS RECEIVING WHOLE-BRAIN RADIOTHERAPY Web-Based Electronic Data Submission is now available for the following form: NP - 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 05/27/2010 will be returned to the site for web submission. Please notify your joint center institutions and affiliates who are not on e-mail. Sandrine Geinoz, PhD, CCRP RTOG Data Management DATE: May 13, 2010 SUBJECT: RTOG 0324, Amended Amended 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)" [a closed study], Amendment 6: Patient follow up has been amended to occur throughout the patient's lifetime, and sites are asked to perform annual follow-up evaluations. Please see the complete Summary of Changes at http://www.rtog.org/members/protocols/0324/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/0324/0324.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 follow up has been amended to the patient's lifetime, sites are required to re-consent patients enrolled to this trial. Sites must submit IRB approval for the amendment to CTSU. Please notify your affiliates that are not on e-mail. DATE: May 11, 2010 SUBJECT: Web-Based Electronic Data Submission Update & Form Revision Notice - RTOG 0517 RTOG 0517 Randomized Phase III trial to evaluate radiopharmaceuticals and zoledronic acid in the palliation of osteoblastic metastases from lung, breast and prostate cancer Web-Based Electronic Data Submission is now available for the following form: PQ-FACT-G 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 shartson@acr-arrs.org Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214. The PQ 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=0517/0517pq.pdf The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date PQ FACT-G    PQa     05/04/10   Changes Made: Internal element number changes Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions received after 05/14/2010 will be returned to the site for transcription. Please notify your joint center institutions and affiliates who are not on e-mail. Roseann Bonanni, CCRP RTOG Data Management DATE: May 11, 2010 SUBJECT: RTOG 0627, Amended Amended RTOG 0627, "Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme," Amendment 7: In response to a request for an amendment (RA) from CTEP, the protocol was amended to reflect the migration of the Comprehensive Adverse Events and Potential Risks List (CAEPR) for dasatinib from Common Terminology Criteria for Adverse Events (CTCAE) 3.0 language to CTCAE 4.0 language. Please Note: Although the revised CAEPR reflects the CTCAE migration, there is no new or modified risk information for dasatinib. Sites can access the summaries of changes for the amendment at http://www.rtog.org/members/protocols/0627/summary_changes.html Sites can download a copy of the protocol for IRB review by accessing the RTOG web site http://www.rtog.org/members/protocols/0627/0627.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 of the amendment 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. 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: May 10, 2010 SUBJECT: New Director of RTOG Clinical Trials Administration I am happy to announce that Sharon Hartson Stine is the new Director of Clinical Trials Administration for the Radiation Therapy Oncology Group. As of today, May 10, 2010, please welcome her as the new RTOG Group Administrator. We will benefit from her knowledge, expertise and years of experience with the organization. Her phone number at RTOG Headquarters in Philadelphia is 215-717-0834 and her email address is shartson@acr-arrs.org DATE: May 7, 2010 SUBJECT: RTOG 0617 APRIL/MAY 2010 NEWSLETTER Hello: Attached please find the 0617 Newsletter for the months of April and May 2010. Regards, Treena - RTOG 0617 Newsletter April & May 2010.pdf DATE: May 7, 2010 SUBJECT: RTOG 0247 and RTOG 0822 RE-BROADCAST Oxaliplation (NSC 266046) Revised CAEPR (v2.2) and Risk Profile Please see below Broadcast of 30-Apr-2010 and attachments which may not have reached the full RTOG Broadcast list. Please disregard if already received. Attn: RTOG 0247 and RTOG 0822 Principal Investigators and Program Coordinators Please see attached update to Oxaliplatin (NSC 266046) Comprehensive Adverse Events and Potential Risks (CAEPR v2.2) and Risk Profile (please note that a risk profile is being provided for the first time for this agent). Neither enrollment suspension nor amendment of the aforementioned studies is required. However, all sites should follow local IRB or Operations Office procedures and requirements. Thank you. Please notify your affiliates that are not on e-mail. - CAEPR_Oxaliplatin_NSC 266046_v 2.2_03-11-10.doc - Risk Profile_Oxaliplatin_NSC 266046_v 2.2_03-11-10.doc DATE: May 7, 2010 SUBJECT: Form Revision Notice - RTOG 0813 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 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=0813/0813ae.pdf The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date AE Adverse Event Evaluation Form    AEa     05/07/2010   Changes Made: Reviewer reporting-For Headquarters use only. Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions received after May 14, 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: May 6, 2010 SUBJECT: RTOG 0619, Closure: Further information RE: 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" RTOG was recently notified by AstraZeneca of their decision to terminate the clinical research agreement for the above mentioned study. The pharmaceutical company has made a strategic decision not to pursue further investigation of vandetanib in this particular clinical research setting, and therefore, RTOG closed RTOG 0619 to patient accrual on May 3, 2010. The attached letter may be used for submission to local IRBs to notify them of the change in status for this protocol. Please notify your affiliates that are not on e-mail. - Dear RTOG 0619 Investigators letter.doc DATE: May 6, 2010 SUBJECT: The RTOG Meeting Semiannual Meeting June 17 – 20, 2010 May 6, 2010 RTOG Members: The RTOG Meeting Semiannual meeting will be held in Philadelphia, PA from June 17 - 20, 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. To guarantee the room rate of $208/night plus tax, your hotel reservation must be made by May 27th 2010. Registration for the meeting must be received by 4:00pm EST on Friday, June 4th, 2010. Your preregistration is necessary to ensure that the appropriate amounts of resources are 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 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 Clinical Trail Administration DATE: May 4, 2010 SUBJECT: Form Revision Notice - RTOG 0825 RTOG Study # 0825 Study Title: "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 The following forms(s) for this study have been revised. Download the new version from the RTOG web site at http://www.rtog.org/pdf_forms.html?members/forms=0825/0825SR.pdf. The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date SR Radiology Review Form    SRa -     3/25/10   Changes Made: An additional option has been added to the SR form for cases that require code breaking for off protocol treatment, and are not planning to continue onto the Salvage treatment. Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions received after 5/11/2010 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 e-mail 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. Barbara Kaiser, RN RTOG Data Management Denise Manfredi RT(T) RTOG RT. Quality Assurance DATE: May 4, 2010 SUBJECT: RTOG 0825 Net Clinical Benefit Substudy Participation Guidelines 0825 Net Clinical Benefit Substudy Participation Guidelines Patients who have consented to participate in the 0825 Net Clinical Benefits substudy will have NCF assessments and complete the QOL as per the time points specified in the protocol until the time of progression. Patients who have progression and go onto unblinded open label Bevacizumab (salvage treatment) will continue participation in the Net Clinical Benefits component until time of 2nd progression. NCF assessments and QOL will be done in conjunction with the MRI/CT imaging before cycle 1, 4, 7 and 10 (if administered) and 1 month after the final cycle is completed. Those who have progression and do not go onto salvage treatment or are treated on alternative therapy or stop protocol treatment for any other reason will discontinue participation in the Net Clinical Benefit substudy. DATE: May 3, 2010 SUBJECT: RTOG 0825 MARCH/APRIL 2010 NEWSLETTER Hello: Attached please find the 0825 newsletter for the months of March and April. Regards, Treena - RTOG 0825 Newsletter MARCH APRIL 2010.pdf DATE: May 3, 2010 SUBJECT: RTOG 0619, Closed to accrual effective immediately Closed to Accrual 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", has been closed to accrual, effective immediately. Note: Further information and instructions for patients who are enrolled on study will be forthcoming. Please notify your affiliates that are not on e-mail. DATE: May 3, 2010 SUBJECT: RTOG 0618, Closure Notice Closure Notice RTOG 0618, "Phase II Trial of Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Patients with Operable Stage I/II Non-Small Cell Lung Cancer", will close to patient accrual at 5 PM EST Monday, May 17th, as the study has met its accrual objective. Please notify your affiliates that are not on e-mail. DATE: April 30, 2010 SUBJECT: RTOG 0247 and RTOG 0822 Oxaliplatin (NSC 266046) Revised CAEPR (v2.2) and Risk Profile Attn: RTOG 0247 and RTOG 0822 Principal Investigators and Program Coordinators Please see attached update to Oxaliplatin (NSC 266046) Comprehensive Adverse Events and Potential Risks (CAEPR v2.2) and Risk Profile (please note that a risk profile is being provided for the first time for this agent). Neither enrollment suspension nor amendment of the aforementioned studies is required. However, all sites should follow local IRB or Operations Office procedures and requirements. Thank you. Please notify your affiliates that are not on e-mail. - CAEPR_Oxaliplatin_NSC 266046_v 2.2_03-11-10.doc - Risk Profile_Oxaliplatin_NSC 266046_v 2.2_03-11-10.doc DATE: April 27, 2010 SUBJECT: RTOG 0837/ACRIN 6689, Action Letter and Amendment Action Letter and Amendment 1 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" RTOG has received an ACTION LETTER from NCI/NIH for cediranib (AZD2171) (NSC 732208, IND 72740). Accrual of new patients to RTOG 0837/ACRIN 6689 is SUSPENDED until the IRB of record has reviewed and approved the CTEP-approved amendment for this study that addresses the information in the Action Letter. Sites can access the amended protocol at: http://www.rtog.org/members/protocols/0837/0837.pdf Sites can access the complete Summary of Changes for the amendment at http://www.rtog.org/members/protocols/0837/summary_changes.html Patients currently on study may continue on study provided they are informed of the new risks identified as part of the CAEPR update in the Action Letter. The Action Letter is attached and must accompany the amendment. NCI policy requires that the "Version Date" on the protocol title page reflect the date that the most recent amendment was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses. Please submit the amendment and Action Letter to your institutional IRB. A copy should be retained in your protocol file. Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. This amendment involves changes to the risks section of the consent. RTOG recommends re-consenting patients on this trial; however, your local IRB will have the final authority. Note: RTOG has expired all prior site IRB approvals for the study. U.S. sites and Canadian sites must fax a copy of the IRB/REB approval letter to the CTSU Regulatory Office (215-569-0206) prior to registering patients. Please notify your affiliates that are not on e-mail. - ACTION LETTER_Cediranib (AZD2171)_NSC 732208_IND 72740_April 26, 2010.pdf DATE: April 27, 2010 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0837 RTOG 0837 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 Web-Based Electronic Data Submission is now available for the following 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 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 05/07/2010 will be returned to the site for web submission. Please notify your joint center institutions and affiliates who are not on e-mail. Sandrine Geinoz, PhD, CCRP RTOG Data Management DATE: April 26, 2010 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0926 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 Web-Based Electronic Data Submission is now available for the following form: A5-DEMOGRAPHIC DATA 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 web support (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 May 7, 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: April 23, 2010 SUBJECT: RTOG 0539 April 2010 Newsletter Attached is the April 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: Central Pathology Review Observations MRI for Radiation Planning Submission of Surgical Pathology and Surgical Operative Reports Enrollment - 0539 April 2010 Newsletter.pdf DATE: April 23, 2010 SUBJECT: RTOG is Accepting Applications for the RTOG/ACR Radiation Oncology Resident Training Fellowship - DUE date 5/14/10 The Radiation Therapy Oncology Group (RTOG), with support from the American College of Radiology (ACR), has established a Radiation Oncology Resident Training Fellowship. This five-day fellowship at RTOG Headquarters in Philadelphia will focus on introducing residents to radiation oncology research. For more information please visit http://www.rtog.org/research/fellowship.html. Residents interested in applying for the Fellowship must submit an application, including a CV and a brief narrative describing the intended focus of their three-day session. The intended area of focus can be a disease site (RTOG's principal disease sites are: brain, bladder, cervix, breast, head & neck, prostate, and GI sites), an RT treatment modality (IMRT, brachytherapy, stereotactic, 3DCRT), or revolve around an outcomes or translational research question. RTOG staff will help successful applicants finalize their research focus. Applicants must be from a current RTOG member facility in North America. Participation of the resident's home institution as an RTOG member will also be considered during the application review. Each Fellow will also be required to submit a brief review of the value of the experience and a critique of the program at the conclusion of the Fellowship. Applications are due by close of business on May 14th, 2010. Please e-mail your application to RTOG-SCWS@acr-arrs.org. DATE: April 23, 2010 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0920 RTOG #0920 A PHASE III STUDY OF POSTOPERATIVE RADIATION THERAPY (IMRT) +/- CETUXIMAB FOR LOCALLY-ADVANCED RESECTED HEAD AND NECK CANCER Web-Based Electronic Data Submission is now available for the following 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 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 05/07/2010 will be returned to the site for web submission. Please notify your joint center institutions and affiliates who are not on e-mail. Joli Lovarino, BA, CCRP RTOG Data Management DATE: April 22, 2010 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 2: Additional criterion for discontinuation of protocol treatment due to disease progression was included in Section 11.8. Sites can access the complete summary of changes via the RTOG web site at http://www.rtog.org/members/protocols/0622/summary_changes.html Sites 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 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. DATE: April 22, 2010 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0937 RTOG # 0937 Randomized Phase II Study Comparing Prophylactic Cranial Irradiation Alone to Prophylactic Cranial Irradiation and Consolidative Extra-Cranial Irradiation for Extensive Disease Small Cell Lung Cancer (ED-SCLC) Web-Based Electronic Data Submission is now available for the following 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 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 05/07/2010 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: April 21, 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 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=0534/0534i1.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     04/20/10   Changes: Due to the recent amendment, questions 28, 29 and 30 where added. Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions received after 4/30/10 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 Management DATE: April 20, 2010 SUBJECT: RTOG 0534, Amended AMENDED 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". Amendment #2: Revisions were made to protocol eligibility in Section 3.0 and also to the radiation treatment planning in Section 6.0. Sites can access the complete summary of changes for the amendment by accessing the RTOG web site at http://www.rtog.org/members/protocols/0534/summary_changes.html Sites can download a copy of the protocol for IRB review athttp://www.rtog.org/members/protocols/0534/0534.pdf. NCI policy requires that the "Version Date" on the protocol title page reflect the date the amendment was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses. Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. 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 who are not on e-mail. DATE: April 19, 2010 SUBJECT: Web-Based Electronic Data Submission Update - 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 Web-Based Electronic Data Submission is now available for the following form: QL - EORTC-QLC30 (version 3) 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 web support (websupport@acr-arrs.org) Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214. Forms received in paper format after April 30, 2010 will be returned to the site for web submission. Please notify your joint center institutions and affiliates who are not on e-mail. Barbara Kaiser, RN RTOG Data Management DATE: April 19, 2010 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0436 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 Web-Based Electronic Data Submission is now available for the following form: FA - FACT-E (version 4) 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 web support (websupport@acr-arrs.org) Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214. Forms received in paper format after April 30, 2010 will be returned to the site for web submission. Please notify your joint center institutions and affiliates who are not on e-mail. Wendy Bergantz, RN RTOG Data Management DATE: April 19, 2010 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0614 RTOG 0614 A RANDOMIZED, PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF MEMANTINE FOR PREVENTION OF COGNITIVE DYSFUNCTION IN PATIENTS RECEIVING WHOLE-BRAIN RADIOTHERAPY Web-Based Electronic Data Submission is now available for the following form: PQ - FACT-Br 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 web support (websupport@acr-arrs.org) Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214. Forms received in paper format after April 30, 2010 will be returned to the site for web submission. Please notify your joint center institutions and affiliates who are not on e-mail. Sandrine Geinoz, PhD, CCRP RTOG Data Management DATE: April 16, 2010 SUBJECT: RTOG 0211 PROTOCOL NOTICE: NCI SAFETY REPORT for IRESSA RTOG has received safety report(s) from the NCI/NIH for IRESSA 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 study(s) involve IRESSA: RTOG 0211 "A PHASE I/II STUDY OF AN ORAL EPIDERMAL GROWTH FACTOR RECEPTOR TYROSINE KINASE INHIBITOR (EGFR-TKI), ZD 1839 (IRESSA), [NSC# 715055] WITH RADIATION THERAPY IN GLIOBLASTOMA MULTIFORME" Please send the report(s) to your institutional IRB. A copy also should be retained in your protocol file. Please notify your affiliates that are not on e-mail. - Iressa, AE-1439677, Protocol E1302, -ISR.PDF DATE: April 16, 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. 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. - OSI-774, Follow-Up to a Written Report, AE-1727021, Protocol S0727, -FU1.pdf DATE: April 16, 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 CCI-779, AE-1670473, Protocol 8233, -ISR.PDF - Bevacizumab CC-5013, AE-1277486, Protocol 7313, -FU1.pdf - Bevacizumab Sunitinib Malate, AE-1329500, Protocol 7537, -FU1.pdf - Bevacizumab CC-5013, AE-1277486, Protocol 7313, -FU1.pdf - Bevacizumab, AE-1449190, Protocol E1305, -FU1.pdf DATE: April 16, 2010 SUBJECT: RTOG 0837 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR CEDIRANIB RTOG has received safety report(s) from NCI for CEDIRANIB 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 CEDIRANIB: RTOG 0837 " 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 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. - AZD2171, AE-1469546, Protocol 7534, -ISR.PDF DATE: April 15, 2010 SUBJECT: Form Revision Notice - RTOG 0630 RTOG 0630 A Phase II Trial of Image Guided Preoperative Radiotherapy for Primary Soft Tissue Sarcomas of the Extremity 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=0630/0630i1.pdf The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date I1 Initial Evaluation Form    I1a     04/13/10   Changes Made: Q10: "12 Buttocks" was added as a primary location. 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 e-mail. Vanita Patel, MS RTOG Data Management DATE: April 13, 2010 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0937 RTOG # 0937 Randomized Phase II Study Comparing Prophylactic Cranial Irradiation Alone to Prophylactic Cranial Irradiation and Consolidative Extra-Cranial Irradiation for Extensive Disease Small Cell Lung Cancer (ED-SCLC) Web-Based Electronic Data Submission is now available for the following form: 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 04/19/2010 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: April 13, 2010 SUBJECT: RTOG 0618, Amended and Updated Amended and Updated RTOG 0618, "Phase II Trial of Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Patients with Operable Stage I/II Non-Small Cell Lung Cancer", has been amended and updated. Amendment 4: Recurrence definitions and patient follow up were amended. Update: Questions on the 3rd page of the Eligibility Checklist were re-ordered for database purposes. Sites can access the summaries of changes for the amendment and the update 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 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 dates of the amendment 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 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. 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: April 9, 2010 SUBJECT: Shipping specimens to RTOG Biospecimen Resource The RTOG Biospecimen Resource moved from Salt Lake City, Utah to San Francisco, California in 2008. Please do not send specimens to the Salt Lake City address and use this address instead: RTOG BIOSPECIMEN RESOURCE US Postal mailing address (all non-courier packages) RTOG Biospecimen Resource UCSF, Campus Box 1800 (1657 Scott St, room 223) San Francisco, CA 94143-1800 FedEx/Courier address (all courier packages & frozen samples) RTOG Biospecimen Resource UCSF 1657 Scott Street, Room 223 San Francisco, CA 94115 Contact # 415.476.7864 Tel: 415-476-RTOG (7864) Fax: 415-476-5271 Email: RTOG@ucsf.edu Specific shipping instructions can be found in the protocol and additional information can be found here: http://www.rtog.org/pdf_document/RTOG%20SOP%20Manualv4.0.pdf Thank you, RTOG-TRP RTOG-TRP@acr-arrs.org DATE: April 8, 2010 SUBJECT: RTOG 99-10, 0126, 0232, 0233: Amended As mandated by CTEP, the following RTOG GU studies have been amended to replace CTC, v. 2.0 with CTEP's Active Version CTCAE (v. 4.0). NOTE: Institutions will continue to submit patient data via the appropriate study case report forms. For adverse event reporting via AdEERS, sites will utilize CTEP's Active Version CTCAE (v. 4.0). RTOG 99-10 (closed study), "A Phase III Trial to Evaluate the Duration of Neoadjuvant Total Androgen Suppression (TAS) and Radiation Therapy (RT) in Intermediate-Risk Prostate Cancer", Amendment 6 RTOG 0126 (closed study), "A Phase III Randomized Study of High Dose 3D-CRT/IMRT Versus Standard Dose 3D-CRT/IMRT in Patients Treated for Localized Prostate Cancer", Amendment 7 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", Amendment 5 RTOG 0233 (closed study), "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", Amendment 6 Sites can access the complete summary of changes for these amendments by accessing the RTOG web site at: http://www.rtog.org/members/protocols/99-10/summary_changes.html http://www.rtog.org/members/protocols/0126/summary_changes.html http://www.rtog.org/members/protocols/0232/summary_changes.html http://www.rtog.org/members/protocols/0233/summary_changes.html Sites can download a copy of each protocol for IRB review at: http://www.rtog.org/members/protocols/99-10/99-10.pdf http://www.rtog.org/members/protocols/0126/p0126.pdf http://www.rtog.org/members/protocols/0232/0232.pdf http://www.rtog.org/members/protocols/0233/0233.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. DATE: April 8, 2010 SUBJECT: Web Data Submission Update - 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 form: 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 April 16, 2010 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: April 8, 2010 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 5: Section 3.1.1 was amended to clarity that patients who present with N2 or N3 disease and an undetectable NSCLC primary tumor also are eligible for the study. Update: On the page following the title pages, a paragraph was added regarding NCCTG's Endorsement Plus option. Sites can access the summaries of changes for the amendment and the update at http://www.rtog.org/members/protocols/0617/summary_changes.html Sites can download a copy of the protocol for IRB review by accessing the RTOG web site 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 dates of the amendment and update are provided 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 this trial; however, your local IRB will have the final authority. Sites must submit IRB approval for the amendment to CTSU. 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: April 6, 2010 SUBJECT: RTOG 9806, 9802, 9813, Amended As mandated by CTEP, the following RTOG Brain studies have been amended to replace CTC, v. 2.0 with CTEP's Active Version CTCAE (v. 4.0). NOTE: Institutions will continue to submit patient data via the appropriate study case report forms. For adverse event reporting via AdEERS, sites will utilize CTEP's Active Version CTCAE (v. 4.0). RTOG 9806, A Phase II Study of Conventional Radiation Therapy Plus Thalidomide for Supratentorial Glioblastoma RTOG 9802, A Phase II Study of Observation in Favorable Low-Grade Glioma and a Phase III Study of Radiation With or Without PCV Chemotherapy in Unfavorable Low-Grade Glioma RTOG 9813, A Phase III (Phase I Closed) Randomized Study Of Radiation Therapy And Temozolomide (IND #60,265) Versus Radiation Therapy And Nitrosourea For Anaplastic Astrocytoma and Mixed Anaplastic Oligoastrocytoma (Astrocytoma Dominant) Sites can access the complete summary of change for these amendments at http://www.rtog.org/members/protocols/98-06/summary_changes.html http://www.rtog.org/members/protocols/98-02/summary_changes.html http://www.rtog.org/members/protocols/98-13/summary_changes.html Sites can download a copy of each protocol for IRB review by accessing the RTOG web site at https://silver1.phila.acr.org/Clinical_RTOG/FileRendering.pdf http://www.rtog.org/members/protocols/98-02/98-02.pdf https://silver1.phila.acr.org/Clinical_RTOG/FileRendering.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. DATE: April 6, 2010 SUBJECT: RTOG 0211, Amended Amended RTOG 0211, "A Phase I/II Study of an Oral Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI), ZD 1839 (Iressa), [NSC# 715055] With Radiation Therapy in Glioblastoma Multiforme," Amendment 8: As mandated by CTEP, CTC v. 2.0 was replaced with CTEP's Active Version CTCAE (v. 4.0). NOTE: Institutions will continue to submit patient data via the appropriate study case report forms. For adverse event reporting via AdEERS, sites will utilize CTEP's Active Version CTCAE (v. 4.0). Contact information was updated for Dr. Chakravarti and Dr. Robins. Please see the complete Summary of Changes at http://www.rtog.org/members/protocols/0211/summary_changes.html You may download a copy of the protocol for IRB review by accessing the RTOG web site at https://silver1.phila.acr.org/Clinical_RTOG/RTOGSecureProtocolLogin.html 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: April 6, 2010 SUBJECT: Web-Data Submission Update - RTOG 0937 RTOG # 0937 Randomized Phase II Study Comparing Prophylactic Cranial Irradiation Alone to Prophylactic Cranial Irradiation and Consolidative Extra-Cranial Irradiation for Extensive Disease Small Cell Lung Cancer (ED-SCLC) Web-Based Electronic Data Submission is now available for the following form: I1 - Initial Evaluation Form Per previous Broadcasts, web-based data submission became mandatory as of May 14, 2007 for all forms available for web-entry for all cases enrolled through RTOG. A complete listing of forms available for web data submission is available at http://www.rtog.org/members/webreg.html For technical support with web data submission, please 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 04/16/2010 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: April 6, 2010 SUBJECT: RTOG 0227, Amended Amended RTOG 0227, "Phase I/II Study of Pre-Irradiation Chemotherapy With Methotrexate, Rituximab, and Temozolomide and Post-Irradiation Temozolomide for Primary Central Nervous System Lymphoma," Amendment 7: As mandated by CTEP, CTC v. 2.0 was replaced with CTEP's Active Version CTCAE (v. 4.0). NOTE: Institutions will continue to submit patient data via the appropriate study case report forms. For adverse event reporting via AdEERS, sites will utilize CTEP's Active Version CTCAE (v. 4.0). Section 3.1.6 and Eligibility Checklist: Age ? 18 was added because it was inadvertently omitted. Appendix I/Sample Consent: "Annually for five years was corrected to annually." Please see the complete Summary of Changes at http://www.rtog.org/members/protocols/0227/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/0227/0227.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. DATE: April 6, 2010 SUBJECT: RTOG 0212, 0213, 0214, 0239, 0241: Closed Studies Amended As mandated by CTEP, the following closed RTOG Lung studies have been amended to replace CTC, v. 2.0 with CTEP's Active Version CTCAE (v. 4.0): RTOG 0212, "A Phase II/III Randomized Trial of Two Doses (Phase III-Standard Vs. High) and Two High Dose Schedules (Phase II-Once Vs. Twice Daily) for Delivering Prophylactic Cranial Irradiation for Patients with Limited Disease Small Cell Lung Cancer" RTOG 0213, "A Phase I/II Trial of A Cox-2 Inhibitor, Celebrex™ (Celecoxib), with Limited Field Radiation for Intermediate Prognosis Patients with Locally Advanced Non-Small Cell Lung Cancer, with Analysis of Prognostic Factors" RTOG 0214, A Phase III Comparison of Prophylactic Cranial Irradiation Versus Observation In Patients with Locally Advanced Non-Small Cell Lung Cancer" RTOG 0239, "A Phase II Study of Accelerated High Dose Thoracic Irradiation with Concurrent Chemotherapy for Patients with Limited Small Cell Lung Cancer" RTOG 0241, "Phase I Study of Irinotecan and Cisplatin in Combination with Twice Daily Thoracic Radiotherapy (45 Gy) or Once Daily Thoracic Radiotherapy (70 Gy) for Patients with Limited Stage Small Cell Lung Cancer" Sites can access the complete summaries of change for these amendments as follows: http://www.rtog.org/members/protocols/0212/summary_changes.html http://www.rtog.org/members/protocols/0213/summary_changes.html http://www.rtog.org/members/protocols/0214/summary_changes.html http://www.rtog.org/members/protocols/0239/summary_changes.html http://www.rtog.org/members/protocols/0241/summary_changes.html Sites can download a copy of each protocol for IRB review by accessing the RTOG web site as follows: http://www.rtog.org/members/protocols/0212/0212.pdf http://www.rtog.org/members/protocols/0213/0213.pdf http://www.rtog.org/members/protocols/0214/0214.pdf http://www.rtog.org/members/protocols/0239/0239.pdf http://www.rtog.org/members/protocols/0241/0241.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. DATE: April 6, 2010 SUBJECT: RTOG (0320) & 0848 PROTOCOL NOTICE: NCI SAFETY REPORT for ERLOTINIB RTOG eNews April 6, 2010 Mark Gilbert, MD, New RTOG Brain Tumor Committee Co-Chair Mark R. Gilbert, M.D., of The University of Texas M. D. Anderson Cancer Center, has been appointed co-chair of the RTOG Brain Tumor Committee. Dr. Gilbert is the Blanche Bender Professorship in Cancer Research in the Division of Cancer Medicine at M. D. Anderson where he is also a professor and deputy chair of the Department of Neuro-oncology. "Dr. Gilbert has been a leader in the RTOG Brain Tumor Committee for quite some time. He is the principal investigator of our current large phase III double-blind trial of concurrent chemoradiation with adjuvant temozolomide and bevaciazumab for patients with glioblastoma as well as the principal investigator of our previous international study of temozolomide with radiotherapy for this patient group," said Walter J. Curran, Jr., M.D., the RTOG Group Chair and the Executive Director of the Winship Cancer Institute of Emory University. According to Dr. Gilbert, "RTOG Brain Tumor Committee research has received tremendous support from the membership allowing us to mount and complete challenging trials quickly and I am excited about this opportunity to work with RTOG leadership on the group's research." As the co-chair for neuro-oncology of the RTOG Brain Tumor Committee, Dr. Gilbert will work closely with Minesh Mehta, M.D., of the University of Wisconsin, the Chair of the RTOG Brain Tumor Committee, as well as with investigators from the group's scientific core committees for translational research, advanced technology, symptom management, pathology, surgery, and pathology to develop and report on protocols designed to improve the outcome and quality of life of brain tumor patients. Dr. Gilbert succeeds Wai-Kwan Alfred Yung, M.D., the Chairman and Professor of Neurology, Margaret & Ben Love Chair in Clinical Cancer, Department of Neuro-Oncology, Division of Cancer Medicine at M. D. Anderson, as co-chair for neuro-oncology of the RTOG Brain Tumor Committee. According to Dr. Curran, "Dr. Yung's leadership of the neuro-oncology effort of our Brain Tumor Committee has helped make this one of our most successful research efforts and we are very appreciative of his contribution." DATE: April 5, 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. 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. - IMC-A12 OSI-774, AE-1203166, Protocol S0727, -ISR.PDF DATE: April 5, 2010 SUBJECT: RTOG 0837 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR CEDIRANIB RTOG has received safety report(s) from NCI for CEDIRANIB 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 CEDIRANIB: RTOG 0837 " 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 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. - AZD2171, AE-1193109, Protocol 7389, -FU1.pdf DATE: April 5, 2010 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. 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. - Dasatinib (BMS-3544825), AE-1640686, Protocol RTOG-0627, -ISR.PDF DATE: April 5, 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-1366672, Protocol RTOG-0825, -ISR.PDF - Bevacizumab, AE-1003452, Protocol GOG-0213, -ISR.PDF - Bevacizumab, AE-1295253, Protocol E5103, -ISR.PDF - Bevacizumab, AE-1236502, Protocol S0518, -ISR.PDF - Bevacizumab CCI-779, AE-1710309, Protocol E2804, -FU1.pdf - Bevacizumab CCI-779, AE- 1561869, Protocol E2804, -ISR.PDF - Bevacizumab CCI-779, AE-1671222, Protocol E2804, -ISR.PDF - Bay 43-9006 Bevacizumab, AE-1706912, Protocol E2804, -ISR.PDF - Bevacizumab, AE-1544184, Protocol E3204, -ISR.PDF DATE: April 1, 2010 SUBJECT: Form Revision Notice - RTOG 0920 RTOG 0920 A PHASE III STUDY OF POSTOPERATIVE RADIATION THERAPY (IMRT) +/- CETUXIMAB FOR LOCALLY-ADVANCED RESECTED HEAD AND NECK CANCER 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=0920/0920%20QP.pdf The edition code for case report forms are found in the lower right corner of the form. Form Type New Version Code/Date QP Performance Status Scale    QPa     04/01/10   Changes Made: 0 =Not applicable, questionnaire was completed was added under Question 2. The third paragraph under instructions was deleted 'If any of the patient assessment items are answered, complete all questions except Q2 before submitting the form.' 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 e-mail. Vanita Patel, MS RTOG Data Management DATE: April 1, 2010 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0920 RTOG 0920 A PHASE III STUDY OF POSTOPERATIVE RADIATION THERAPY (IMRT) +/- CETUXIMAB FOR LOCALLY-ADVANCED RESECTED HEAD AND NECK CANCER Web-Based Electronic Data Submission is now available for the following quality of life forms: QP - Performance Status Scale for H&N Cancer FA - FACT - H&N DL- Dermatology Life Quality Index (DLQ) L4 - University of Michigan Xerostomia-Related Quality of Life Scale (Xe-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. Forms received in paper format after April 15, 2010 will be returned to the site for web submission. Please notify your joint center institutions and affiliates who are not on e-mail. Vanita Patel, MS RTOG Data Management br> DATE: April 1, 2010 SUBJECT: RTOG 98-04, Amended As mandated by CTEP, the following closed RTOG study has been amended to replace CTC, v. 2.0 with CTEP's Active Version CTCAE (v. 4.0). NOTE: Institutions will continue to submit patient data via the appropriate study case report forms. For adverse event reporting via AdEERS, sites will utilize CTEP's Active Version CTCAE (v. 4.0). RTOG 98-04, "Phase III Trial Of Observation +/- Tamoxifen Vs. RT +/- Tamoxifen For Good Risk Duct Carcinoma In-Situ (DCIS) Of The Female Breast", Amendment 6 Sites can access the complete summary of change for this amendment at http://www.rtog.org/qa/98-04/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/qa/98-04/9804.pdf NCI policy requires that the "Version Date" on the protocol title page reflect the date the amendment was submitted by RTOG to NCI. 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. DATE: April 1, 2010 SUBJECT: RTOG 0116, Amended As mandated by CTEP, the following closed RTOG study has been amended to replace CTC, v. 2.0 with CTEP's Active Version CTCAE (v. 4.0). NOTE: Institutions will continue to submit patient data via the appropriate study case report forms. For adverse event reporting via AdEERS, sites will utilize CTEP's Active Version CTCAE (v. 4.0). RTOG 0116, "A Two-Part Phase I/II Study Of Extended Field External Irradiation And Intracavitary Brachytherapy Combined With Chemotherapy (Weekly Cisplatin-Arm 1) And Amifostine (Weekly Cisplatin And Amifostine-Arm 2) In Carcinoma Of The Cervix With Positive Para-Aortic Or High Common Iliac Lymph Nodes", Amendment 7 Sites can access the complete summary of change for this amendment at http://www.rtog.org/members/protocols/c0116/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/c0116/c0116.pdf NCI policy requires that the "Version Date" on the protocol title page reflect the date the amendment was submitted by RTOG to NCI. 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. DATE: April 1, 2010 SUBJECT: RTOG 0246, Amended As mandated by CTEP, RTOG 0246, "A Phase II Study of a Paclitaxel-Based Chemoradiotherapy Regimen with Selective Surgical Salvage for Resectable Locoregionally Advanced Carcinoma of the Esophagus" (a closed study) has been amended to replace CTC, v. 2.0 with CTEP's Active Version CTCAE (v. 4.0). NOTE: Institutions will continue to submit patient data via the appropriate study case report forms. For adverse event reporting via AdEERS, sites will utilize CTEP's Active Version CTCAE (v. 4.0). Sites can access the complete summary of change for Amendment 3 at http://www.rtog.org/members/protocols/0246/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/0246/0246.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. DATE: April 1, 2010 SUBJECT: RTOG 0129 and 0244, Amended As mandated by CTEP, the following closed RTOG Head and Neck studies have been amended to replace CTC, v. 2.0 with CTEP's Active Version CTCAE (v. 4.0). NOTE: Institutions will continue to submit patient data via the appropriate study case report forms. For adverse event reporting via AdEERS, sites will utilize CTEP's Active Version CTCAE (v. 4.0). RTOG 0129, "A Phase III Trial Of Concurrent Radiation and Chemotherapy (Followed By Surgery for Residual Primary/N2-3 Nodal Disease) for Advanced Head and Neck Carcinoma", Amendment 7 RTOG 0244, "A Phase II Study of Submandibular Salivary Gland Transfer to the Submental Space Prior to Start of Radiation Treatment for Prevention of Radiation-Induced Xerostomia in Head and Neck Cancer Patients", Amendment 5 Sites can access the complete summary of change for these amendments at http://www.rtog.org/members/protocols/h0129/summary_changes.html and http://www.rtog.org/members/protocols/0244/summary_changes.html Sites can download a copy of each protocol for IRB review by accessing the RTOG web site at at http://www.rtog.org/members/protocols/h0129/h0129.pdf and http://www.rtog.org/members/protocols/0244/0244.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. DATE: March 31, 2010 SUBJECT: RTOG 0539 March 2010 Newsletter Attached is the March 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 Central Pathology Review Form Clarification Surgical Operative Reports Reminder Enrollment Information - 0539 March Newsletter.pdf DATE: March 30, 2010 SUBJECT: Form Revision Notice - RTOG 0619 RTOG 0619 A RANDOMIZED PHASE II TRIAL OF CHEMORADIOTHERAPY VERSUS CHEMORADIOTHERAPY AND VANDETANIB FOR HIGH-RISK POSTOPERATIVE ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK Form Revision 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%20ST.pdf The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date ST Specimen Transmittal Form    STb     03/26/10   Changes Made: P4 has been deleted as part of the required enclosures with this form A place has been added for the RAs e-mail address. Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions received after April 21st will be returned to the site for transcription. Please notify your joint center institutions and affiliates who are not on e-mail. Joli Lavarino, BA, CCRP RTOG Data Management DATE: March 30, 2010 SUBJECT: Form Revision Notice - RTOG 0920 RTOG 0920 A PHASE III STUDY OF POSTOPERATIVE RADIATION THERAPY (IMRT) +/- CETUXIMAB FOR LOCALLY-ADVANCED RESECTED HEAD AND NECK CANCER 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=0920/0920%20ST.pdf The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date ST Specimen Transmittal Form    STa     03/26/10   Changes Made: P4 has been deleted as part of the required enclosures with this form A place has been added for the RAs e-mail address. Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions received after April 21st will be returned to the site for transcription. Please notify your joint center institutions and affiliates who are not on e-mail. Joli Lavarino, BA, CCRP RTOG Data Management DATE: March 30, 2010 SUBJECT: RTOG 0822, Updated Updated 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" (A closed study), Update: Title Page: Dr. Hong's e-mail address corrected; Section 12.2: Reference to QA guidelines removed from data submission table; Appendix II: typographical error removed from pre-treatment parameters. Please see the complete Summary of Changes at http://www.rtog.org/members/protocols/0822/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/0822/0822.pdf The "Update Date" on the protocol title page indicates that editorial/administrative changes were made to the protocol. IRB review of an update is not required; however, these changes must be reported to site IRBs. Please notify your affiliates that are not on e-mail. DATE: March 30, 2010 SUBJECT: RTOG 0436 MARCH 2010 NEWSLETTER Hello: Attached please find the 0436 Newsletter for March. Regards, Treena - RTOG 0436 Newsletter MARCH 2010.pdf DATE: March 29, 2010 SUBJECT: RTOG 0617 FEBRUARY/MARCH 2010 NEWSLETTER Hello: Attached please find the 0617 Newsletter for the months of February and March. Regards, Treena - RTOG 0617 Newsletter FEB MARCH 2010.pdf DATE: March 26, 2010 SUBJECT: Form Revision Notice - RTOG 0815 Dear RTOG Members: The RTOG Meeting Semiannual meeting will be held in Philadelphia, PA from June 17 - 20, 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 amounts of resources are 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 Friday, June 4th, 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 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 Clinical Trail Administration DATE: March 25, 2010 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 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%20I1.pdf The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date I1 Initial Evaluation Form    I1a     03/25/10   Changes Made: Q#11c-deleted total % of core biopsies taken 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 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 that is collected on the forms should be directed to RTOG Data Management at 215-574-3214. Discard obsolete versions and commence use of the revised edition immediately. Obsolete versions received after April 2, 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, CCRP RTOG Data Management DATE: March 25, 2010 SUBJECT: Form Revision Notice - RTOG 0618 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 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=0618/0618F1.pdf. The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date F1 Follow-up Form    F1b     03/25/2010   Changes Made: Q#5-added Target Volume Only and Q#17 added Involved Lobe Failure 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 e-mail. Roseann Bonanni, CCRP RTOG Data Management DATE: March 25, 2010 SUBJECT: Form Revision Notice - RTOG 0631 RTOG #0631 PHASE II/III STUDY OF IMAGE-GUIDED RADIOSURGERY/SBRT FOR LOCALIZED SPINE METASTASIS 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=0631/0631i1.pdf The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date I1 Initial Evaluation Form    I1a     03/24/10   Changes Made: Q#10-Are all spinal metastases planned to be treated according to the protocol? 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 e-mail. Roseann Bonanni, CCRP RTOG Data Management DATE: March 25, 2010 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    I1c     3-25-10   Changes made: Questions 22 and 23 were added to the form. 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: March 25, 2010 SUBJECT: Form Revision Notice - RTOG 0937 RTOG # 0937 Randomized Phase II Study Comparing Prophylactic Cranial Irradiation Alone to Prophylactic Cranial Irradiation and Consolidative Extra-Cranial Irradiation for Extensive Disease Small Cell Lung Cancer (ED-SCLC) 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=0937/0937%20I1.pdf The edition code for case report forms are found in the lower right corner of the form. Form Type New Version Code/Date I1    I1a     03/18/2010   Changes Made: Pre chemotherapy tumor measurements 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: March 25, 2010 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 2: (Section 3.1) The oncologic criteria concerning initial presentation of disease have been relaxed; Gleason scores of 7 are now allowed for patients that have PSA 20 ng/mL. Please see 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 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. DATE: March 25, 2010 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", Update: At the request of the RTOG Biospecimen Resource, Appendix X was corrected. Please see the complete Summary of Changes at http://www.rtog.org/members/protocols/0619/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/0619/0619.pdf The "Update Date" on the protocol title page indicates that editorial/administrative changes were made to the protocol. IRB review of an update is not required; however, these changes must be reported to site IRBs. Please notify your affiliates that are not on e-mail. DATE: March 25, 2010 SUBJECT: RTOG 0848, Amended Amended RTOG 0848, "A Phase III Trial Evaluating Both Erlotinib and Chemoradiation as Adjuvant Treatment for Patients with Resected Head of Pancreas Adenocarcinoma", Amendment 1: Section 6.0 was amended to refine the details of radiotherapy planning. Please see the complete Summary of Changes at http://www.rtog.org/members/protocols/0848/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/0848/0848.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: March 23, 2010 SUBJECT: RTOG eNews: RTOG Semiannual Meeting Materials Available RTOG eNews March 23, 2010 RTOG Semiannual Meeting Materials Available on Web The RTOG semiannual meeting will be held June 17-20, 2010 at the Loews Philadelphia Hotel. The online meeting registration portal is now available (https://registrations.acr.org/rtog/) and 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. 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 April 19, 2010. 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: March 23, 2010 SUBJECT: NSABP B-39/RTOG 0413 Partial Breast Irradiation (PBI) and Accrual Update Attn: NSABP B-39/RTOG 0413 Principal Investigators and Program Coordinators Please see the attached memo, “NSABP B-39/RTOG 0413 Partial Breast Irradiation (PBI) and Accrual Update”. Thank you. - Broadcast 3-23-10.pdf DATE: March 23, 2010 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0631 RTOG#0631 PHASE II/III STUDY OF IMAGE-GUIDED RADIOSURGERY/SBRT FOR LOCALIZED SPINE METASTASIS Web-Based Electronic Data Submission is now available for the following form: FA-FACT-G 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 3/31/10 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 23, 2010 SUBJECT: RTOG 0631, Amended Amended RTOG 0631, "Phase II/III Study of Image-Guided Radiosurgery/SBRT for Localized Spine Metastasis," Amendment 2: Radiosurgery planning was clarified. 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. 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. DATE: March 23, 2010 SUBJECT: RTOG Biospecimen Resource Hours The RTOG Biospecimen Resource will be closed in observance of the Cesar Chavez Holiday on Friday March 26th.The staff requests that no frozen biospecimens be shipped after Wednesday the 24th, and that sites store samples at -80°C and wait to ship on Monday the 29th. (See below for alternate Frozen Biospecimen storage conditions.) Kit requests will be processed up until 10am (PST) on Thursday the 25th and resume on Monday the 29th. Thank you for your cooperation Please note the following alternatives for sites without access to -80°C freezer.: If a -80°C freezer is not available for storage of frozen biospecimens 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 OR Samples can be stored in plenty of dry ice for up to one week, replenishing daily OR Samples can be stored in liquid nitrogen vapor phase Please email questions to RTOG-TRP@acr-arrs.org. Thank you. DATE: March 18, 2010 SUBJECT: Web-based Electronic Data Submission Update - RTOG 0926 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 Web-Based Electronic Data Submission is now available for the following form: PQ - American Urologic Association (AUA) Symptom Score 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 web support (websupport@acr-arrs.org) Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214. Forms received in paper format after March 26, 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: March 18, 2010 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0712 RTOG 0712 A Phase II Randomized Study for Patients with Muscle-Invasive Bladder Cancer Evaluating Transurethral Surgery And Concomitant Chemoradiation by Either BID Irradiation Plus 5-Fluorouracil And Cisplatin or QD Irradiation Plus Gemcitabine Followed by Selective Bladder Preservation And Gemcitabine/Cisplatin Adjuvant Chemotherapy Web-Based Electronic Data Submission is now available for the following form: PQ - American Urologic Association (AUA) Symptom Score 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 web support (websupport@acr-arrs.org) Questions regarding information being collected on the forms should be directed to RTOG Data Management at 215-574-3214. Forms received in paper format after March 26, 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: March 17, 2010 SUBJECT: RTOG 0937, Activated Activated RTOG 0937, "Randomized Phase II Study Comparing Prophylactic Cranial Irradiation Alone to Prophylactic Cranial Irradiation and Consolidative Extra-Cranial Irradiation for Extensive Disease Small Cell Lung Cancer (ED-SCLC)" Institutions can download a copy of the protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/protocols/0937/0937.pdf Forms for this study can be accessed on the RTOG web site at http://www.rtog.org/members/forms/0937/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. DATE: March 17, 2010 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0539 RTOG 0539 PHASE II TRIAL OF OBSERVATION FOR LOW-RISK MENINGIOMAS AND OF RADIOTHERAPY FOR INTERMEDIATE AND HIGH-RISK MENINGIOMAS Web-Based Electronic Data Submission is now available for the following form: 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 March 26, 2010 will be returned to the site for web submission. Please notify your joint center institutions and affiliates who are not on e-mail. Barbara Kaiser, RN RTOG Data Management DATE: March 16, 2010 SUBJECT: Form Revision Notice - RTOG 0619 RTOG 0619 A RANDOMIZED PHASE II TRIAL OF CHEMORADIOTHERAPY VERSUS CHEMORADIOTHERAPY AND VANDETANIB FOR HIGH-RISK POSTOPERATIVE ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK Form Revision 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%20I1.pdf The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date I1 Initial Evaluation Form    I1a     03/04/10   Changes: Question #23c: Element #283 - Clinical T4 Tumor was added under Pathologic Risk Factors Discard obsolete versions and commence use of the revised edition 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. Joli Lavarino RTOG Data Management DATE: March 16, 2010 SUBJECT: Web-Based Electronic Data Submission Update - 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 Web-Based Electronic Data Submission is now available for the following 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 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 March 26, 2010 will be returned to the site for web submission. Please notify your joint center institutions and affiliates who are not on e-mail. Vanita Patel, MS RTOG Data Management DATE: March 16, 2010 SUBJECT: Web-Based Electronic Data Submission Update - RTOG 0126 RTOG 0126 A PHASE III RANDOMIZED STUDY OF HIGH DOSE 3D-CRT/IMRT VERSUS STANDARD DOSE 3D-CRT/IMRT IN PATIENTS TREATED FOR LOCALIZED PROSTATE CANCER Web-Based Electronic Data Submission is now available for the following quality of life forms: PQ-International Index of Erectile Function Questionnaire (IIEFQ) FA-Functional Alterations due to Changes in Elimination (FACE) SP-Spitzer Quality of Life Index (SQLI) 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 March 26, 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: March 16, 2010 SUBJECT: RTOG 0915, Amended Amended 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", Amendment 1: Sections 6.4.1 and 6.5.1 were amended to provide more details regarding the planning CT and the rib dose limit. Please see the complete Summary of Changes at http://www.rtog.org/members/protocols/0915/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/0915/0915.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: March 16, 2010 SUBJECT: RTOG 0619, Amended Amended RTOG 0619, "A Randomized Phase II Trial of Chemoradiotherapy Versus Chemoradiotherapy and Vandetanib for High-Risk Postoperative Advanced Squamous Cell Carcinoma of the Head And Neck", Amendment 2: Patients with clinical T4a tumors are now eligible for the study. Please see the complete Summary of Changes at http://www.rtog.org/members/protocols/0619/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/0619/0619.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: March 15, 2010 SUBJECT: CALGB 30610/RTOG 0538, amendments: Further Important Information Further important information for RTOG sites participating in CALGB 30610/RTOG 0538, "Phase III Comparison of Thoracic Radiotherapy Regimens In Patients With Limited Small Cell Lung Cancer Also Receiving Cisplatin and Etoposide", a CALGB-coordinated study: RTOG previously broadcast CALGB's Update 4 on March 9th. Subsequently, CALGB provided the summaries of change for Updates 1-3, which are attached. The current 30610/0538 protocol, which includes Updates 1-4, can be downloaded 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 the RTOG Director of Regulatory Compliance, RTOG sites can submit Updates 1-4 of the study to their local IRBs within 90 days of this broadcast and will be in compliance. 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 have further questions regarding CALGB's protocol or updates, please contact the CALGB Protocol Coordinator, Colleen Watt, cboyle@uchicago.edu. - 30610-0538 update 1 SOC.pdf - 30610-0538 update 2 SOC.pdf - 30610-0538 update 3 SOC.pdf DATE: March 10, 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-1900497, Protocol CALGB-90601, -ISR.PDF DATE: March 10, 2010 SUBJECT: RTOG 0837 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR CEDIRANIB RTOG has received safety report(s) from NCI for CEDIRANIB 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 CEDIRANIB: RTOG 0837 " 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 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. - AZD2171, Follow-Up to a Written Report, AE-1053869, Protocol PBTC-020, -FU1.pdf - AZD2171, AE-1847830, Protocol 7147, -FU1.pdf DATE: March 10, 2010 SUBJECT: RTOG (0324), (0234), (0522), 0436, 0617 & 0920 PROTOCOL NOTICE: NCI SAFETY REPORTS FOR CETUXIMAB This may be a duplication if your institution is participating in either of the RTOG Erlotinib Studies (0320) or 0848 Please note this report originates from the NCI not BMS, ImClone or Lilly RTOG has received safety report(s) from the 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. 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. - OSI-774, Follow-Up to a Written Report, AE-1670060, Protocol 6980, -FU1.pdf DATE: March 10, 2010 SUBJECT: RTOG (0320) & 0848 PROTOCOL NOTICE: NCI SAFETY REPORT for ERLOTINIB RTOG has received safety report(s) from NCI for CEDIRANIB 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 CEDIRANIB: RTOG 0837 " 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 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. DATE: March 10, 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. 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. - IMC-A12 OSI-774, AE-1559936, Protocol S0727, -ISR.PDF - OSI-774, Follow-Up to a Written Report, AE-1670060, Protocol 6980, -FU1.pdf DATE: March 10, 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 CCI-779, AE-1448075, Protocol GOG-0229G, -ISR.PDF - Bevacizumab Sunitinib Malate, Follow-Up to a Written Report, AE-1939558, Protocol 7537, -FU1.pdf 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.