Temozolomide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Anaplastic Oligodendrogliomas or Mixed Anaplastic Oligoastrocytomas
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy and radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining temozolomide with radiation therapy in treating patients who have newly diagnosed anaplastic oligodendrogliomas or mixed anaplastic oligoastrocytomas.
Brain and Central Nervous System Tumors
Procedure: neoadjuvant therapy
Radiation: radiation therapy
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial Of Pre-Irradiation And Concurrent Temozolomide In Patients With Newly Diagnosed Anaplastic Oligodendrogliomas And Mixed Anaplastic Oligoastrocytomas|
- Rate of progression at 6 months (post-chemotherapy/pre-irradiation progression) [ Time Frame: From start of treatment to 6 months ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: From registration to date of death or last follow-up ] [ Designated as safety issue: No ]
|Study Start Date:||July 2002|
|Primary Completion Date:||April 2005 (Final data collection date for primary outcome measure)|
Experimental: Pre-RT temozolomide, RT plus temozolomide
Pre-radiation therapy (RT) temozolomide, RT plus temozolomide
|Drug: temozolomide Procedure: neoadjuvant therapy Radiation: radiation therapy|
- Determine the rate of progression in patients with newly diagnosed anaplastic oligodendrogliomas or mixed anaplastic oligoastrocytomas treated with neoadjuvant and concurrent temozolomide with radiotherapy.
- Determine the toxicity of this regimen in these patients.
- Determine the survival of patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to response to neoadjuvant temozolomide (stable disease or partial response [PR] vs complete response [CR]).
Patients receive oral temozolomide on days 1-7 and 15-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with CR or PR receive 2 courses beyond CR or PR.
Within 6 weeks after completion of neoadjuvant temozolomide, patients with stable disease or PR undergo radiotherapy 5 days a week for 6.5 weeks. Patients also receive oral temozolomide daily for 42 days concurrently with radiotherapy.
Patients with CR after completion of neoadjuvant temozolomide undergo observation.
Patients are followed at 9 and 12 months, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A maximum of 37 patients will be accrued for this study within 12 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00033280
Show 39 Study Locations
|Study Chair:||Michael A. Vogelbaum, MD, PhD||The Cleveland Clinic|