SUMMARY OF CHANGES
Update Date: February 24, 2006
RTOG 0513, A Phase I/II Trial of Temozolomide, Motexafin Gadolinium, and 60 Gy Fractionated Radiation for Newly Diagnosed Supratentorial Glioblastoma Multiforme
Study Chair: David G. Brachman, MD, FACRO; 602-406-3170; dbrachman@azoncology.com
RTOG 0513 has been updated as follows:
Section 1.1, third paragraph, last line; Section 1.6, mid-paragraph; Section 7.2:
Units for temozolomide were corrected to mg/m2.
NOTE: These are editorial/administrative changes 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 an amendment.
An updated protocol is available on the RTOG website: www.rtog.org
SUMMARY OF CHANGES
Update Date: February 21, 2006
RTOG 0513, A Phase I/II Trial of Temozolomide, Motexafin Gadolinium, and 60 Gy Fractionated Radiation for Newly Diagnosed Supratentorial Glioblastoma Multiforme
Study Chair: David G. Brachman, MD, FACRO; 602-406-3170; dbrachman@azoncology.com
RTOG 0513 has been updated as follows:
Entire protocol: The protocol was repaginated to conform with the RTOG standard of having page 1 start at the first page of the Introduction (Section 1.0.), with no page numbers included on the Title Page, Schema Page, and Eligibility Checklist.
Appendix I/Sample Consent, Risks and side effects related to MGd: In the "rare but serious" listing, the spelling of "pooling" in the third bullet was corrected.
NOTE: These are editorial/administrative changes 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 an amendment.
An updated protocol is available on the RTOG website: www.rtog.org
SUMMARY OF CHANGES
Update Date: February 9, 2006
RTOG 0513, A Phase I/II Trial of Temozolomide, Motexafin Gadolinium, and 60 Gy Fractionated Radiation for Newly Diagnosed Supratentorial Glioblastoma Multiforme
Study Chair: David G. Brachman, MD, FACRO; 602-406-3170; dbrachman@azoncology.com
RTOG 0513 has been updated as follows:
Eligibility Checklist - Question 21 (Treatment Assignment) was deleted as it erroneously implies that patient treatment is selected by the institution placing the patient on the study. (Treatment assignments are made by the RTOG once the institution has registered the case to the study.)
Section 5.1 - Second paragraph: The web address in the first bullet was updated. Second-to-last paragraph: Instructions were added for assistance with web registration.
Section 10.2.5 - The contact information for LDS Hospital was updated.
NOTE: These are editorial/administrative changes 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 an amendment.
An updated protocol is available on the RTOG website: www.rtog.org