0625 Broadcast DATE: July 18, 2008 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513,(0525) & 0625 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE ******Please note: The safety report cover page states it is an initial submission when indeed it is a follow-up. The Medwatch reflects the accurate information*** RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 9813 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" 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 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" RTOG 0625 “A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA” 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. - 2007SP018230 FU8.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 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 at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: July 11, 2008 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513,(0525) & 0625 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE ***Please note: The safety report cover page states it is an initial submission when indeed it is a follow-up. The Medwatch reflects the accurate information*** RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 9813 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" 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 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" RTOG 0625 “A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA” 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. - 2008SP010385 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 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 at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: June 13, 2008 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513,(0525) & 0625 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 9813 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" 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 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" RTOG 0625 “A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA” 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. - 2008SP009832 Initial.pdf - 2008SP010385 Initial.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 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 at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: June 13, 2008 SUBJECT: RTOG (0411), 0417, 0615 & 0625 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety report(s) from NCI for BEVACIZUMAB The Following RTOG studies involve BEVACIZUMAB: RTOG (0411) "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417 "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG 0615 "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG 0625 “A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA” 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-1653936 Protocol GOG-0218 No 2.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates who are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@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 at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: June 9, 2008 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513, 0525 & 0625 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE ****Please Note**** Safety Report 2008SP009302 is a re-broadcast. There is newly added information to the attached report. This report replaces the Safety Report broadcast initially on 5/29/2008. RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 9813 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" 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 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" RTOG 0625 “A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA” 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. - 2008SP009306 FU1.pdf - 2008SP009302 Initial Update.pdf - 2008SP003086 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 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 at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: June 9, 2008 SUBJECT: RTOG (0411), 0417, 0615 & 0625 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety report(s) from NCI for BEVACIZUMAB The Following RTOG studies involve BEVACIZUMAB: RTOG (0411) "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417 "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG 0615 "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG 0625 “A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA” 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-1653936 GOG-0218 - 1.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 who are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@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 at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 29, 2008 SUBJECT: RTOG (0411), 0417, 0615 & 0625 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety report(s) from NCI for BEVACIZUMAB The Following RTOG studies involve BEVACIZUMAB: RTOG (0411) "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417 "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG 0615 "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG 0625 “A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA” 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 Investigator Notification Genentech MFR 253621- May 20 2008.pdf - Bevacizumab Investigator Notification Genentech MFR 257028 - May 20 2008.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 who are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@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 at www.rtog.orgby selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 29, 2008 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513, 0525 & 0625 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 9813 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" 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 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" RTOG 0625 “A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA” 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. - 2007SP018230 FU7.pdf - 2007SP007552FU9.pdf - 2008SP009306.pdf - 2008SP009302.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 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 at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 16, 2008 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513, 0525 & 0625 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" 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 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" 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. - 2008SP001606 F-U 2.pdf - 2008SP001606 F-U 1.pdf - 2007SP018230 FU6.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 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 at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 2, 2008 SUBJECT: RTOG (0411), 0417, 0615 & 0625 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety report(s) from NCI for BEVACIZUMAB The Following RTOG studies involve BEVACIZUMAB: RTOG (0411) "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417 "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG 0615 "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG 0625 “A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA” 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 1536472 RTOG-0625 FU 1.pdf - Bevacizumab and Cetuximab 1199283 S0536 - FU 1.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 who are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@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 at www.rtog.orgby selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 2, 2008 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513, 0525 & 0625 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 9813 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" 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 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" RTOG 0625 “A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA” 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. - 2008SP006508 FU1.pdf - 2008SP006508 initial.pdf - 2008SP000756 F-U2.pdf - 2008SP001606 initial.pdf - 2008SP001728 FU2.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html 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 at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 1, 2007 SUBJECT: RTOG (0411), 0417, 0615 & 0625 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB During a recent audit of broadcast RTOG Safety Reports, it was discovered that the following Safety Reports for Bevacizumab, which were previously broadcast on 2/8/07, may not have been received by all participating sites. Please disregard any duplicate reports. RTOG has received safety report(s) from NCI for BEVACIZUMAB Please note although these are both follow-up Reports, they contain all the information in the initial reports, which were not originally provided by CTEP. The Following RTOG studies involve BEVACIZUMAB: RTOG (0411) "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417 "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG 0615 "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG 0625 “A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA” Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - Bevacizumab-Investigator Notification-Genentech-Mfr.Rpt. 230653-January-29-2007.pdf - Bevacizumab-Investigator Notification-Genentech-Mfr Rpt 233053-January-29-2007.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 at www.rtog.orgby selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: May 1, 2008 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513, 0525 & 0625 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE During a recent audit of broadcast RTOG Safety Reports, it was discovered that the following Safety Reports for Temozolomide, which were previously broadcast on 2/7/07 and 3/15/07, may not have been received by all participating sites. Please disregard any duplicate reports. RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG 9813 "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" 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 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" RTOG 0625 “A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA” 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. - 22Jan2007_2006SP008904_analysis.doc - 22Jan2007_2006SP008904_Medwatch.pdf - 23Jan2007_2006SP004547_analysisfu1.doc - 23Jan2007_2006SP004547_MedWatch_FU1.pdf - 24Jan2007_2007SP001239_analysis.doc - 24Jan2007_2007SP001239_Medwatch.pdf - 26Jan2007_2007SP000310_analysis.doc - 26Jan2007_2007SP000310_Medwatch.pdf - 26Jan2007_2006SP008904_analysisfu2.doc - 26Jan2007_2006SP008904_MedWatch_FU2.pdf - 31Jan2007_2006SP004547_analysisfu2.doc - 31Jan2007_2006SP004547_MedWatch_FU2.pdf - 12Mar2007_2007SP003140_analysisfu2.doc - 12Mar2007_2007SP003140_MedWatch_FU2.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html 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 at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 18, 2008 SUBJECT: RTOG (0411), 0417, 0615 & 0625 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety report(s) from NCI for BEVACIZUMAB The Following RTOG studies involve BEVACIZUMAB: RTOG (0411) "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417 "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG 0615 "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" 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. - Bevacizumab1230483RTOG-0625-ISRFU1.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 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 at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 11, 2008 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513, 0525 & 0625 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" 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 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" 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. - 2008SP000756 F-U1.pdf - 2007SP018230 FU5.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 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 at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 11, 2008 SUBJECT: RTOG (0411), 0417, 0615 & 0625 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety report(s) from NCI for BEVACIZUMAB The Following RTOG studies involve BEVACIZUMAB: RTOG (0411) "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417 "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG 0615 "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" 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 Investigator Notification Genentech MFR 254163 04-04-2008.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 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 at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: March 28, 2008 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513, 0525 & 0625 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" 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 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" 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. - 2007SP007552 FU8.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 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 at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: February 29, 2008 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513, 0525 & 0625 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" 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 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" 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. - 2008SP03086 initial.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 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 at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: February 29, 2008 SUBJECT: RTOG (0411), 0417, 0615 & 0625 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety report(s) from NCI for BEVACIZUMAB The Following RTOG studies involve BEVACIZUMAB: RTOG (0411) "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417 "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG 0615 "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - Bevacizumab - Follow-up Investigator Notification - Genentech Rpt 250945 - February-21-2008.pdf - Bevacizumab - Investigator Notification - Genentech Rpt 255513 - February-21-2008.pdf - Bevacizumab Cetuximab 1435303 - S0536 - ISR.pdf - Bevacizumab 1459647 - RTOG-0625 - ISR (2).pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@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 at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: February 15, 2008 SUBJECT: RTOG RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513, 0525 & 0625 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" 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 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" 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. - 2007SP018230 FU4.pdf - 2008SP001728 FU 1.pdf - 2008SP002006 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@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 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 15, 2008 SUBJECT: RTOG (0411), 0417, 0615 & 0625 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety report(s) from NCI for BEVACIZUMAB The Following RTOG studies involve BEVACIZUMAB: RTOG (0411) "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417 "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG 0615 "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" 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-Investigator Notification-Genentech Rpt 250945.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@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 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 8, 2008 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513, 0525 & 0625 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" 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 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" 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. - 2007SP018230 FU3.pdf - 2006041447 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@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 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 8, 2008 SUBJECT: FW: RTOG (0411), 0417, 0615 & 0625 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received a non urgent request for a protocol amendment from NCI for BEVACIZUMAB The Following RTOG Bevacizumab studies are involved in this amendment: 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" The information included here requires revisions to the protocol, a copy of this information must be sent to your IRB. A copy must also be retained in the protocol study file. The amended protocol will be forthcoming. - bevacizumab Amend 01-2008.doc.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@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 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 8, 2008 SUBJECT: RTOG (0411), 0417, 0615 & 0625 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety report(s) from NCI for BEVACIZUMAB The Following RTOG studies involve BEVACIZUMAB: RTOG (0411) "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417 "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG 0615 "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - Bevacizumab and Sunitinib Malate Investigator Notification 253339.pdf - Bevacizumab-Investigator Notification-Genentech Rpt252935-January-24-2008 (2).pdf - Bevacizumab Sunitinib Malate 1165164 7537-ISR.pdf - Bevacizumab-Investigator Notification-Genentech Rpt250866-December-17-2007.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@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 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, 14, 2008 SUBJECT: RTOG (0411), 0417, 0615 & 0625 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety report(s) from NCI for BEVACIZUMAB The Following RTOG studies involve BEVACIZUMAB: RTOG (0411) "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417 "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG 0615 "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" 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 OSI-774-Investigator Notification-Genentech Rpt 248756-January-2-2008.pdf - Bevacizumab-Investigator Notification-Genentech Rpt 250367-January-2-2008.pdf - Bevacizumab-Investigator Notification-Genentech's Dear Investigator Letter-January-2-2008.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@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 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, 10, 2008 SUBJECT: RTOG 0625, Amended Amended RTOG 0625/ACRIN 6677, "A Randomized Phase II Trial of Bevacizumab With Irinotecan or Bevacizumab With Temozolomide in Recurrent Glioblastoma," Amendment 2 Sites can access the complete summary of changes at http://www.rtog.org/members/protocols/0625/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/0625/0625.pdf NCI policy requires that the "Version Date" on the protocol title page reflect the date the amendment was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses. Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. Expedited review is allowed; however, site IRB requirements take precedence. Please notify your affiliates that are not on e-mail. To share a comment or ask a question, access the Headquarters Information and Telephone Listing on the RTOG web site, www.rtog.org, under "Member Info", or call 1-800-227-5463, ext. 4189, which provides a menu to reach the Headquarters departments. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@phila.acr.org Web registration is available 24/7. Information and instructions available at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: January, 4, 2008 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513, 0525 & 0625 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" 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 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" 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. - 2007SP023974 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@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 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, 4, 2008 SUBJECT: RTOG (0411), 0417, 0615 & 0625 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety report(s) from NCI for BEVACIZUMAB The Following RTOG studies involve BEVACIZUMAB: RTOG (0411) "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417 "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG 0615 "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" 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-Investigator Notification-Genentech Rpt 250866-December-17-2007.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@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 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: December 20, 2007 SUBJECT: RTOG (0411), 0417, 0615 & 0625 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety report(s) from NCI for BEVACIZUMAB The Following RTOG studies involve BEVACIZUMAB: RTOG (0411) "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417 "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG 0615 "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" 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-1696275-RTOG-0625-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@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 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: December 13, 2007 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513, 0525 & 0625 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" 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 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" 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. - 2007SP020357 FU3.pdf - 2007SP018230 FU2.pdf - 2007SP012156 FU3.pdf - 2007sp023870 initial.pdf - 2007SP023974 initial.pdf - 2007SP012156 FU4.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@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 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: December 13, 2007 SUBJECT: RTOG (0411), 0417, 0615 & 0625 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety report(s) from NCI for BEVACIZUMAB The Following RTOG studies involve BEVACIZUMAB: RTOG (0411) "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417 "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG 0615 "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" 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-Investigator Notification-Genentech Rpt 248340-October-30-2007.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@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 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: November 29, 2007 SUBJECT: RTOG (0411), 0417, 0615 & 0625 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR BEVACIZUMAB RTOG has received safety report(s) from NCI for BEVACIZUMAB The Following RTOG studies involve BEVACIZUMAB: RTOG (0411) "A PHASE II STUDY OF BEVACIZUMAB WITH CONCURRENT CAPECITABINE AND RADIATION FOLLOWED BY MAINTENANCE GEMCITABINE AND BEVACIZUMAB FOR LOCALLY ADVANCED PANCREATIC CANCER" RTOG 0417 "A PHASE II STUDY OF BEVACIZUMAB IN COMBINATION WITH DEFINITIVE RADIOTHERAPY AND CISPLATIN CHEMOTHERAPY IN UNTREATED PATIENTS WITH LOCALLY ADVANCED CERVICAL CARCINOMA" RTOG 0615 "A PHASE II STUDY OF CONCURRENT CHEMORADIOTHERAPY USING INTENSITY-MODULATED RADIATION THERAPY (IMRT) + BEVACIZUMAB (BV) [NSC 708865; IND 7921] FOR LOCALLY OR REGIONALLY ADVANCED NASOPHARYNGEAL CANCER" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" 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-1425725-RTOG-0625-ISR.pdf - Bevacizumab BAY 43-9006-1896903 1129949-6555-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@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 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: November 27, 2007 SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513, 0525 & 0625 PROTOCOL NOTICE: SCHERING-PLOUGH SAFETY REPORT FOR TEMOZOLOMIDE RTOG has received safety report(s) from Schering-Plough for Temozolomide The Following RTOG studies also involve Temozolomide: RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265) RTOG (0131) "A PHASE II TRIAL OF PRE-IRRADIATION AND CONCURRENT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED ANAPLASTIC OLIGODENDROGLIOMAS AND MIXED ANAPLASTIC OLIGOASTROCYTOMAS" 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 0320 "A PHASE III TRIAL COMPARING WHOLE BRAIN RADIATION AND STEREOTACTIC RADIOSURGERY ALONE VERSUS WITH TEMOZOLOMIDE OR GEFITINIB IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND 1-3 BRAIN METASTASES" RTOG (0420) "A PHASE II STUDY OF RADIATION THERAPY PLUS LOW DOSE TEMOZOLOMIDE FOLLOWED BY TEMOZOLOMIDE PLUS IRINOTECAN FOR GLIOBLASTOMA MULTIFORME" RTOG 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS" RTOG 0513 "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME" RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA" RTOG 0625 "A RANDOMIZED PHASE II TRIAL OF BEVACIZUMAB WITH IRINOTECAN OR BEVACIZUMAB WITH TEMOZOLOMIDE IN RECURRENT GLIOBLASTOMA" 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. - 2006062337 FU2.pdf - 2007SP014751 FU4.pdf - 2007SP020934 FU1.pdf - 2007SP020357 FU2.pdf - 2007SP007552 FU7.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@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 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: November 16, 2007 SUBJECT: RTOG 0625, Temporary Closure Temporary Closure RTOG 0625/ACRIN 6677,