SUMMARY OF CHANGES
Update Date: November 22, 2004
RTOG BR-0131, “A Phase II Trial of Pre-Irradiation and Concurrent Temozolomide in Patients with Newly Diagnosed Anaplastic Oligodendrogliomas and Mixed Anaplastic Oligoastrocytomas”
Study Chair: Michael A. Vogelbaum, M.D., Ph.D., (216) 444-8564, vogelbm@neus.ccf.orgRTOG
RTOG BR-0131 has been updated as follows:
Title Page – The closure date for this study was changed to April 30, 2004, which reflects the date that the study originally closed.
NOTE: This is an editorial/administrative change to the protocol. NCI now requires that these changes be documented on the protocol title page with the date of the update noted as “Update Date”, not as a revision.
An updated protocol is available (no password required) on the RTOG website: http://www.rtog.org/
SUMMARY OF CHANGES
Update Date: July 24, 2003
RTOG BR-0131, “A Phase II Trial of Pre-Irradiation and Concurrent Temozolomide in Patients with Newly Diagnosed Anaplastic Oligodendrogliomas and Mixed Anaplastic Oligoastrocytomas”
Study Chair: Michael A. Vogelbaum, M.D., Ph.D., (216) 444-8564, vogelbm@neus.ccf.org
RTOG BR-0131 has been updated as follows:
Eligibility Checklist, Page 2 — Added question 21, “Has the Central Pathology Report been received?”
Section 10.4.5 – Updated the pathology contact at LDS Hospital to--ldhflinn@ihc.com
NOTE: This is an editorial/administrative change to the protocol. NCI now requires that these changes be documented on the protocol title page with the date of the update noted as “Update Date”, not as a revision.
An updated protocol is available (no password required) on the RTOG website: http://www.rtog.org/
SUMMARY OF CHANGES
Update Date: June 2, 2003
RTOG BR-0131, “A Phase II Trial of Pre-Irradiation and Concurrent Temozolomide in Patients with Newly Diagnosed Anaplastic Oligodendrogliomas and Mixed Anaplastic Oligoastrocytomas”
Study Chair: Michael A. Vogelbaum, M.D., Ph.D., (216) 444-8564, vogelbm@neus.ccf.org
RTOG BR-0131 has been updated as follows:
Title Page — Dr. Vogelbaum’s e-mail address has been updated.
Appendix III – In the Eligibility Section, corrected the typo vascular to endothelial.
NOTE: This is an editorial/administrative change to the protocol. NCI now requires that these changes be documented on the protocol title page with the date of the update noted as “Update Date”, not as a revision.
An updated protocol is available (no password required) on the RTOG website: http://www.rtog.org/
SUMMARY OF CHANGES
Revision 1, December 23, 2002
RTOG BR-0131, “A Phase II Trial of Pre-irradiation and Concurrent Temozolomide in Patients with Newly Diagnosed Anaplastic Oligodendrogliomas and Mixed Anaplastic Oligoastrocytomas”
Study Chair: Michael A. Vogelbaum, M.D., Ph.D. (216) 444-8564; FAX # (216) 444-9170; vogelbm@ccf.org
IRB Review Requirements:
( ) Full board review required
(X) Expedited review is permissible; however, site IRB requirements take precedence.
( ) No review required
RTOG BR-0131 has been revised as follows:
Cover Page — “Version Date” replaces “Current Edition” per NCI guidelines.
Eligibility Question #11 — “> 12 years” has been changed to “> 12 weeks” to be consistent with the Schema Page and Section 3.1.4.
Sections 10.3, 10.3.3 — Changes were made indicating that the slides for central pathology review will be sent to Mr. Russ Hamilton at the Mayo Clinic rather than directly to Dr. Scheithauer.
Appendix IA — Under “What are My Rights as a Participant”, the paragraph “A group of experts in brain cancer from the RTOG Brain Committee, the study chairs, and the RTOG study statistician will be reviewing the data from this research periodically throughout the study” has been added.
A revised protocol is available (no password required) on the RTOG website: http://www.rtog.org/