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DATE: November 10, 2005
SUBJECT: RTOG 0330, (0118), (9806) PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR Thalidomide
RTOG has received safety report(s) from the NCI/NIH for Thalidomide
The Following RTOG study(s) involve Thalidomide:
RTOG 0330 "A PILOT PHASE II STUDY OF PRE-OPERATIVE RADIATION THERAPY AND THALIDOMIDE (IND 48832; NSC 66847) FOR LOW GRADE PRIMARY SOFT TISSUE SARCOMA OR PRE-OPERATIVE MAID/THALIDOMIDE/RADIATION THERAPY FOR HIGH/INTERMEDIATE GRADE PRIMARY SOFT TISSUE SARCOMA OF THE EXTREMITY OR BODY WALL"
RTOG (0118) "A PHASE III STUDY OF CONVENTIONAL RADIATION THERAPY PLUS THALIDOMIDE (NSC# 66847) VERSUS CONVENTIONAL RADIATION THERAPY FOR MULTIPLE BRAIN METASTASES"
RTOG (9806) "A PHASE II STUDY OF CONVENTIONAL RADIATION THERAPY PLUS THALIDOMIDE FOR SUPRATENTORIAL GLIOBLASTOMA (NSC # 66847)"
Please send the report(s) to your institutional IRB. A copy also should be retained in your protocol file.
The safety report(s) do not require revisions to the above protocol at this time.
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
- Thalidomide Investigator Notification October 18, 2005 [PDF]
Please notify your affiliates that are not on e-mail.
If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@phila.acr.org
Please do not contact David Corrie 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
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DATE: March 17, 2005
SUBJECT: RTOG 0330, (0118), (9806) CORRECTION of PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR Thalidomide
RTOG has received a CORRECTION of a previously broadcast safety report from the NCI/NIH for Thalidomide.
The original safety report, broadcast on 11/8/04, was inadvertently missing the third page of the MedWatch Form. The entire safety report is attached to this broadcast. Please update your records. The NCI apologizes for this inconvenience
Please see Broadcast e-mail for March 17, 2005.
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DATE: March 11, 2005
SUBJECT: RTOG 0330, (0118), (9806) Protocol Notice: Updated Comprehensive Adverse Event and Potential Risks (CAEPR) List for Thalidomide
RTOG has received an updated Comprehensive Adverse Event and Potential Risks(CAEPR) List from the NCI/NIH for Thalidomide
The Following RTOG study(s) involve Thalidomide:
RTOG 0330 "A PILOT PHASE II STUDY OF PRE-OPERATIVE RADIATION THERAPY AND THALIDOMIDE (IND 48832; NSC 66847) FOR LOW GRADE PRIMARY SOFT TISSUE SARCOMA OR PRE-OPERATIVE MAID/THALIDOMIDE/RADIATION THERAPY FOR HIGH/INTERMEDIATE GRADE PRIMARY SOFT TISSUE SARCOMA OF THE EXTREMITY OR BODY WALL"
RTOG (0118) "A PHASE III STUDY OF CONVENTIONAL RADIATION THERAPY PLUS THALIDOMIDE (NSC# 66847) VERSUS CONVENTIONAL RADIATION THERAPY FOR MULTIPLE BRAIN METASTASES"
RTOG (9806) "A PHASE II STUDY OF CONVENTIONAL RADIATION THERAPY PLUS THALIDOMIDE FOR SUPRATENTORIAL GLIOBLASTOMA (NSC # 66847)"
Please send the updated list to your institutional IRB. A copy also should be retained in your protocol file.
This current CAEPR List is for informational purposes only at this time. Any events noted in this list that are not already documented in the protocol will be included in a future amendment to this study protocol. RTOG will provide a follow up broadcast when the amended protocol is available, if additions are necessary.
- CAEPR Cover Memo Thalidomide [PDF]
- CAEPR Thalidomide [DOC]
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 David Corrie at dcorrie@phila.acr.org <mailto:dcorrie@phila.acr.org>
Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org <http://www.rtog.org> by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments.
Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html
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DATE: February 4, 2005
SUBJECT: RTOG 0330, (0118), (9806) PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR Thalidomide
RTOG has received safety report(s) from the NCI/NIH for Thalidomide
The Following RTOG study(s) involve Thalidomide:
RTOG 0330 "A PILOT PHASE II STUDY OF PRE-OPERATIVE RADIATION THERAPY AND THALIDOMIDE (IND 48832; NSC 66847) FOR LOW GRADE PRIMARY SOFT TISSUE SARCOMA OR PRE-OPERATIVE MAID/THALIDOMIDE/RADIATION THERAPY FOR HIGH/INTERMEDIATE GRADE PRIMARY SOFT TISSUE SARCOMA OF THE EXTREMITY OR BODY WALL"
RTOG 0118 "A PHASE III STUDY OF CONVENTIONAL RADIATION THERAPY PLUS THALIDOMIDE (NSC# 66847) VERSUS CONVENTIONAL RADIATION THERAPY FOR MULTIPLE BRAIN METASTASES"
RTOG 9806 "A PHASE II STUDY OF CONVENTIONAL RADIATION THERAPY PLUS THALIDOMIDE FOR SUPRATENTORIAL GLIOBLASTOMA (NSC # 66847)"
Please send the report(s) to your institutional IRB. A copy also should be retained in your protocol file.
The safety report(s) do not require revisions to the above protocol at this time.
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
- Thalidomide Celgene Safety Report [PDF]
If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@phila.acr.org <mailto:dcorrie@phila.acr.org>
Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org <http://www.rtog.org> by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments.
Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html
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DATE: February 2, 2005
SUBJECT: RTOG BR-0118 Protocol Update Notice
Updated:
RTOG BR-0118, "A PHASE III STUDY OF CONVENTIONAL RADIATION THERAPY PLUS THALIDOMIDE (NSC# 66847) VERSUS CONVENTIONAL RADIATION THERAPY FOR MULTIPLE BRAIN METASTASES" was updated to reflect Benjamin Movsas, M.D. as the new Quality of Life Chair. Please see the complete Summary of Changes at http://www.rtog.org/members/protocols/br0118/summary_changes.html
You may download a copy of the updated protocol by accessing the RTOG website at http://www.rtog.org/members/protocols/br0118/br0118.pdf
NOTE: This update is an editorial/administrative change to the protocol. NCI requires that this change be documented on the protocol title page as “Update Date,” not as a revision. IRB review is not required; however, this change must be reported to site IRBs.
If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@phila.acr.org
Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html
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DATE: November 8, 2004
SUBJECT: RTOG 0330, (0118), (9806) PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR Thalidomide
RTOG has received safety report(s) from the NCI/NIH for Thalidomide
The Following RTOG study(s) involve Thalidomide:
RTOG 0330 "A PILOT PHASE II STUDY OF PRE-OPERATIVE RADIATION THERAPY AND THALIDOMIDE (IND 48832; NSC 66847) FOR LOW GRADE PRIMARY SOFT TISSUE SARCOMA OR PRE-OPERATIVE MAID/THALIDOMIDE/RADIATION THERAPY FOR HIGH/INTERMEDIATE GRADE PRIMARY SOFT TISSUE SARCOMA OF THE EXTREMITY OR BODY WALL"
RTOG 0118 "A PHASE III STUDY OF CONVENTIONAL RADIATION THERAPY PLUS THALIDOMIDE (NSC# 66847) VERSUS CONVENTIONAL RADIATION THERAPY FOR MULTIPLE BRAIN METASTASES"
RTOG 9806 "A PHASE II STUDY OF CONVENTIONAL RADIATION THERAPY PLUS THALIDOMIDE FOR SUPRATENTORIAL GLIOBLASTOMA (NSC # 66847)"
Please send the report(s) to your institutional IRB. A copy also should be retained in your protocol file.
The safety report(s) do not require revisions to the above protocol at this time.
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
- Thalidomide Safety Report [PDF]
If you require a hard copy of the report(s), please contact Marie D'Amico, RTOG Regulatory Associate, mdamico@phila.acr.org, 215-574-3185. Please provide your Institution number for identification and tracking purposes to receive a copy of the report(s).
If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@phila.acr.org <mailto:dcorrie@phila.acr.org>
Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org <http://www.rtog.org> by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments.
Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html
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DATE: October 8, 2004
SUBJECT: RTOG 0330, 0118, 9806 PROTOCOL NOTICE: NCI/NIH SAFETY REPORT FOR Thalidomide
RTOG has received safety report(s) from the NCI/NIH for Thalidomide
The Following RTOG study(s) involve Thalidomide:
RTOG 0330 "A PILOT PHASE II STUDY OF PRE-OPERATIVE RADIATION THERAPY AND THALIDOMIDE (IND 48832; NSC 66847) FOR LOW GRADE PRIMARY SOFT TISSUE SARCOMA OR PRE-OPERATIVE MAID/THALIDOMIDE/RADIATION THERAPY FOR HIGH/INTERMEDIATE GRADE PRIMARY SOFT TISSUE SARCOMA OF THE EXTREMITY OR BODY WALL"
RTOG 0118 "A PHASE III STUDY OF CONVENTIONAL RADIATION THERAPY PLUS THALIDOMIDE (NSC# 66847) VERSUS CONVENTIONAL RADIATION THERAPY FOR MULTIPLE BRAIN METASTASES"
RTOG 9806 "A PHASE II STUDY OF CONVENTIONAL RADIATION THERAPY PLUS THALIDOMIDE FOR SUPRATENTORIAL GLIOBLASTOMA (NSC # 66847)"
Please send the report(s) to your institutional IRB. A copy also should be retained in your protocol file.
The safety report(s) do not require revisions to the above protocol at this time.
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
- Safety Report for Thalidomide [PDF]
If you require a hard copy of the report(s), please contact Marie D'Amico, RTOG Regulatory Associate, mdamico@phila.acr.org, 215-574-3185. Please provide your Institution number for identification and tracking purposes to receive a copy of the report(s).
If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@phila.acr.org <mailto:dcorrie@phila.acr.org>
Please do not contact David Corrie for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org <http://www.rtog.org> by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments.
Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html
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DATE: July 16, 2004
SUBJECT: RTOG 0118 PROTOCOL NOTICE
Closure
RTOG 0118, " A Phase III Study of Conventional Radiation Therapy Plus Thalidomide (NSC# 66847) versus Conventional Radiation Therapy for Multiple Brain Metastases,” will be permanently closed to patient accrual effective immediately.
Based upon interim analysis results of RTOG 0118 which were presented to the RTOG Data Monitoring Committee on June 16, 2004, the DMC has recommended closing RTOG 0118 due to lack of efficacy. Study drug may no longer be supplied by NCI. Physicians who feel that their patients have benefitted from thalidomide should give consideration to establishing alternative sources of drug supply. Patients will continue to be followed per protocol.
Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html
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