Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase II Trial of Pre-Irradiation Chemotherapy With BCNU, Cisplatin and Oral Etoposide Combined With Radiation Therapy in the Treatment of Grade 3 Astrocytoma (Anaplastic Astrocytoma)
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 more than one drug with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus
radiation therapy in treating patients who have newly diagnosed anaplastic astrocytoma.
OBJECTIVES: I. Determine the efficacy of carmustine, cisplatin, and etoposide given prior to
and during radiotherapy in patients with anaplastic astrocytoma. II. Assess the toxic
effects associated with this regimen in these patients. III. Evaluate this regimen in terms
of fatigue, depression, excessive daytime somnolence, and quality of life in these patients.
OUTLINE: Patients receive carmustine IV over 1 hour on days 1-3, oral etoposide on days 1-21
and 29-49, and cisplatin IV over 1-2 hours on days 1-3 and 29-31. Treatment repeats every 8
weeks for 3 courses. Patients receive radiotherapy concurrently with the third course of
chemotherapy. Quality of life is assessed every 4 months for 1 year, every 6 months for 4
years, and then annually for 5 years. Patients are followed every 3 months for 5 years and
then annually thereafter.
PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study within 20 months.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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