NCT00006386
Radiation Therapy Followed by Carmustine in Treating Patients Who Have Supratentorial Glioblastoma Multiforme
PHASE2
COMPLETED
NCT00006386
INTERVENTIONAL
A Phase II Trial of Accelerated Radiotherapy Using Weekly Stereotactic Conformal Boosts For Supratentorial Glioblastoma Multiforme
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.
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
Brain and Central Nervous System Tumors
- TREATMENT
-
- Type: DRUG
- Name: carmustine
- Description:
- Arm Group Labels: External beam radiotherapy with stereotactic boost
-
- Type: RADIATION
- Name: radiation therapy
- Description:
- Arm Group Labels: External beam radiotherapy with stereotactic boost
-
- Type: RADIATION
- Name: stereotactic radiosurgery
- Description:
- Arm Group Labels: External beam radiotherapy with stereotactic boost
- Radiation Therapy Oncology Group