Clinical Trial: Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Anaplastic Astrocytoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Astrocy

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 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.

Detailed Summary:

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.

Sponsor: Alliance for Clinical Trials in Oncology

Current Primary Outcome: overall survival [ Time Frame: Up to 10 years ]

Original Primary Outcome:

Current Secondary Outcome: quality of life [ Time Frame: Up to 10 years ]

Original Secondary Outcome:

Information By: Alliance for Clinical Trials in Oncology

Dates:
Date Received: November 1, 1999
Date Started: February 1999
Date Completion:
Last Updated: July 12, 2016
Last Verified: July 2016