Clinical Research Details
Title:
RTOG -0525 A Phase III Trial Comparing Conventional Adjuvant Temozolomide with Dose-Intensive Temozolomide in Patients with Newly Diagnosed Glioblastoma
Purpose:
The purpose of this study is to determine if dose-intensifying adjuvant temozolomide during chemoradiation treatment enhances treatment efficacy as measured by overall survival.
Study Number:
108814
Number of Patients:
834
Elgibility:
Patients must have a histologicallly proven diagnosis of glioblastoma multiforme. At least one block of tissue will need to be available for analysis of MGMT status. A diagnosis must be made by surgical biopsy or excision. The tumor must have a supratentorial component. A diagnostic CT or MRI pre- and post-operatively must be complete. Concomitant chemotherapy and radiation must begin within five weeks of surgery.
Treatment:
Standard-dose temozolomide will start on the first day of radiation treatments. You will take the temozolomide orally once daily continuously (seven days a week) for a maximum of seven weeks. You will receive radiation Monday through Friday for a total of 30 radiation treatments. After the radiation is completed, you will be randomized by a computer to either group 1 (the standard dose schedule) or group 2 (dose-dense schedule).
Principal Investigator:
Enrollment Phone:
(708) 216-2568