Status and phase
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Study type
Funder types
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About
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as temozolomide, carmustine, and lomustine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: This randomized phase III trial is studying radiation therapy and temozolomide to see how well they work compared to radiation therapy and carmustine or lomustine in treating patients with anaplastic astrocytoma or mixed gliomas.
Full description
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (under 50 vs 50 and over), Karnofsky performance status (60-80% vs 90-100%), and prior surgery (biopsy only vs resection).
Phase I
Phase III
Patients are randomized to 1 of 2 treatment arms (3rd arm was dropped).
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: Phase I: 30 patients; Phase III: 454 patients (227 per treatment arm) within 4 years.
Enrollment
Sex
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically proven unifocal anaplastic astrocytoma or mixed gliomas, including the following:
Anaplastic astrocytoma
Mixed oligodendroglial/astrocytic tumors
No vascular proliferation and necrosis
Increased cellularity, pleomorphism, and nuclear atypia allowed
No tumor predominantly located in the posterior fossa (i.e., brainstem or cerebellum)
Patients with prior biopsy proven low grade astrocytoma who now have anaplastic astrocytoma and have had no prior radiotherapy or chemotherapy also eligible
Study therapy must begin within 6 weeks of diagnosis
No spinal cord tumors, spinal drop metastases, or metastases to noncontiguous meninges
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Primary purpose
Allocation
Interventional model
Masking
230 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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