|
 |
DATE: September 25, 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.
- 2007SP018230FU9.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 <<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: 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 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: 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 (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, 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 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: 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 28, 2008
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 # 6. The contact information for Dr. Glass was revised.
Please see the complete summary of changes at http://www.rtog.org/members/protocols/0227/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/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. 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/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 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 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: 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: December 18, 2007
SUBJECT: RTOG Holiday Drug Shipment Hours
The deadline to order drug for the holidays is approaching fast. Please be aware of your institution's supply of pharmaceutical supplied drugs during the holiday shipment hiatus and reorder now or plan accordingly.
BMS [(0324), (0234) & 0522] the distributor of Cetuximab/Erbitux reminds us:
The holiday season is quickly approaching. We remind you that BMS drug distribution center will be closed for Cetuximab shipments as follows:
| Warehouse Closure Date |
Last Shipment Date |
| Monday, December 24th through Wednesday, January 2nd, 2008 |
Wednesday, December 19th |
BIOLOGICS [(9813), 0525 & 0521] and IV SOLUTIONS [0227, 0320, 0424, 0517 & 0518] the distributors of TEMOZOLOMIDE, TAXOTERE & ZOMETA on behalf of the supporting pharmaceutical companies for RTOG studies remind us:
The holiday season is quickly approaching. The BIOLOGICS & IV SOLUTIONS drug distribution centers will be closed for all drug shipments as follows:
| Dates of Closure | Comments |
| Monday 12/24/07 |
Shipment sent on Friday 12/21/07will be delivered on Monday 12/24/07. |
| Tuesday 12/25/07 |
| Monday 12/31/07 |
Shipments sent on Friday 12/28/07 will be delivered on Monday 12/31/07. |
| Tuesday 01/01/08 |
|
|
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: 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 14, 2007
SUBJECT: RTOG (9813), 0227, 0320, 0424. & 0525 PROTOCOL NOTICE: TEMOZOLOMIDE Holiday Drug Shipment Hours
BIOLOGICS [(9813) & 0525] and IV SOLUTIONS [0227, 0320 & 0424] the distributors of TEMOZOLOMIDE on behalf of Schering-Plough for RTOG studies remind us:
The holiday season is quickly approaching. The BIOLOGICS & IV SOLUTIONS drug distribution centers will be closed for Temozolomide shipments as follows:
| Dates of Closure | Comments |
| Thursday 11/22/07 |
Shipments sent on Wednesday 11/21/07 will not be delivered until Friday 11/23/07. |
| Friday 11/23/07 |
| Monday 12/24/07 |
Shipment sent on Friday 12/21/07 will be delivered on Monday 12/24/07. |
| Tuesday 12/25/07 |
| Monday 12/31/07 |
Shipments sent on Friday 12/28/07 will be delivered on Monday 12/31/07. |
| Tuesday 01/01/08 |
BIOLOGICS distributes Temozolomide for the Following RTOG studies:
RTOG (9813) "A PHASE I/III RANDOMIZED STUDY OF RADIATION THERAPY AND TEMOZOLOMIDE VERSUS RADIATION THERAPY AND BCNU FOR ANAPLASTIC ASTROCYTOMA" (IND #60,265)
RTOG 0525 "PHASE III TRIAL COMPARING CONVENTIONAL ADJUVANT TEMOZOLOMIDE WITH DOSE-INTENSIVE TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA"
IV SOLUTIONS distributes Temozolomide for the Following RTOG studies:
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 0424 "A PHASE II STUDY OF A TEMOZOLOMIDE-BASED CHEMORADIOTHERAPY REGIMEN FOR HIGH RISK LOW-GRADE GLIOMAS"
HAPPY HOLIDAYS!
|
|
DATE: November 7, 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 REGIMENFOR 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 FU1.pdf
- 2007SP020934 (15 day) initial.pdf
- 2007SP007552 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
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: October 26, 2007
SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513 & 0525 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"
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.
- 2007SP012156 F-U 2.pdf
- 2007SP018230 FU1.pdf
- 2007SP020357 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
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: October 5, 2007
SUBJECT:RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513 & 0525 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"
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.
- 2007SP014751 FU3.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 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: September 18, 2007
SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513 & 0525 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"
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.
- 2007SP014751 F-U2.pdf
- 2007SP007552 FU4.pdf
- 2007SP007552 FU 5.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: August 29, 2007
SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513 & 0525 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”
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 FU 3.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: August 7, 2007
SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513 & 0525 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 REGIMENFOR 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"
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.
- 2007SP014751 15 day Initial 15 day 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
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 27, 2007
SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513 & 0525 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"
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.
- 2007SP14808 7 day 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: July 20, 2007
SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513 & 0525 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 RINOTECAN 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"
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.
- 2007SP012156 (7 day ) Initial 2007SP012478 (15 day ) Initial.pdf
- 2007SP006588 (15 day) F-U 1 2007SP012478 (15 day) Initial.pdf
- 2007SP007552 (15 day) F-U 1.pdf
- 2007SP012156 (15 day) Initial.pdf
- 2007SP006588 (15 day ) F-U 2.pdf
- 2007SP012478 (15 day ) F-U 1.pdf
- 2007SP006588 (15 day) F-U 1 2007SP007552 (15 day) F-U 1 2007SP012478 (15 day) F-U 1.pdf
- 2007SP006588 (15 day) F-U 2 2007SP012156 (15 day) F-U 1.pdf
- 2007SP012156 (15 Day) F-U 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
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 7, 2007
SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513 & 0525 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"
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.
- 04Jun2007_2007SP003140_analysis.doc
- 04Jun2007_2007SP003140_Medwatch.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: June 5, 2007
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 5: Neuroimaging was revised to include head CT scans if MRIs are not feasible; several pre-treatment assessments were revised from one week to four weeks prior to the first treatment cycle. Please see the complete summary of changes at http://www.rtog.org/members/protocols/0227/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/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. 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: June 5, 2007
SUBJECT: RTOG (9813), (0131), 0227, 0320, (0420), 0424. 0513 & 0525 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"
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.
- 31May2007_2007SP007552_analysis.doc
- 31May2007_2007SP007552_Medwatch.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 | |
