A Phase II Trial Of Pre-Irradiation And Concurrent Temozolomide In Patients With Newly Diagnosed Anaplastic Oligodendrogliomas And Mixed Anaplastic Oligoastrocytomas
Overview
- Phase
- Phase 2
- Intervention
- temozolomide
- Conditions
- Brain and Central Nervous System Tumors
- Sponsor
- Radiation Therapy Oncology Group
- Enrollment
- 42
- Locations
- 39
- Primary Endpoint
- Rate of progression at 6 months (post-chemotherapy/pre-irradiation progression)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
OBJECTIVES: * 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Pre-RT temozolomide, RT plus temozolomide
Pre-radiation therapy (RT) temozolomide, RT plus temozolomide
Intervention: temozolomide
Pre-RT temozolomide, RT plus temozolomide
Pre-radiation therapy (RT) temozolomide, RT plus temozolomide
Intervention: neoadjuvant therapy
Pre-RT temozolomide, RT plus temozolomide
Pre-radiation therapy (RT) temozolomide, RT plus temozolomide
Intervention: radiation therapy
Outcomes
Primary Outcomes
Rate of progression at 6 months (post-chemotherapy/pre-irradiation progression)
Time Frame: From start of treatment to 6 months
Secondary Outcomes
- Overall Survival(From registration to date of death or last follow-up)