Brain and Central Nervous System Tumors
Conditions
Keywords
adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma
Brief summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of radiation therapy followed by carmustine in treating patients who have supratentorial glioblastoma multiforme.
Detailed description
OBJECTIVES: * Determine the overall and progression-free survival in patients with supratentorial glioblastoma multiforme treated with accelerated radiotherapy and conformal stereotactic radiotherapy boost followed by carmustine. * Determine the short and long-term toxicity of this regimen in these patients. * Determine the feasibility of this regimen in these patients. OUTLINE: Patients receive daily accelerated radiotherapy 5 days a week on weeks 1-2. On weeks 3-6, patients receive accelerated radiotherapy 4 days a week (3 days a week on week 6) and conformal stereotactic radiotherapy boost once weekly. Patients then receive carmustine IV over 1-2 hours on days 1-3 every 8 weeks for 6 courses beginning within 1 month after the completion of radiotherapy. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 76 patients will be accrued for this study within 15 months.
Interventions
DRUGcarmustine
RADIATIONradiation therapy
RADIATIONstereotactic radiosurgery
Sponsors
National Cancer Institute (NCI)
Radiation Therapy Oncology Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed supratentorial glioblastoma multiforme by surgical biopsy or resection within 5 weeks of study * Postoperative residual contrast enhancing tumor and resection tumor cavity together no greater than 60 mm in maximum diameter * No well-differentiated or anaplastic astrocytomas or multifocal glioma * No tumors originating in the brainstem * No residual tumor within 10 mm of optic chiasm * No recurrent glioblastoma multiforme PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * Zubrod 0-1 Life expectancy: * Not specified Hematopoietic: * Hemoglobin greater than 9 g/dL * Absolute neutrophil count greater than 1,500/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic: * Bilirubin less than 2.0 mg/dL * Serum glutamate pyruvate transaminase (SGPT) or serum glutamate oxaloacetate transaminase (SGOT) less than 2 times normal Renal: * Creatinine less than 1.8 mg/dL * Blood urea nitrogen (BUN) less than 30 mg/dL Pulmonary: * Chest x-ray normal OR * Diffusion capacity of lung for carbon monoxide (DLCO) greater than 60% predicted Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Neurologic functional status 0-3 * No other prior malignancy within the past 5 years except carcinoma in situ of the cervix or bladder, ductal carcinoma in situ of the breast, or nonmelanomatous skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Concurrent steroids allowed Radiotherapy: * Not specified Surgery: * See Disease Characteristics Other: * Concurrent anticonvulsants allowed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 18 months. |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free Survival | From registration to date of progression, death or last follow-up. Analysis occurs at the same time as the primary outcome analysis. |
Countries
Canada, United States
Outcome results
None listed