EFFECT OF DIBROMODULCITOL PLUS BCNU ON FREE INTERVAL AND SURVIVAL OF PATIENTS WITH SUPRATENTORIAL MALIGNANT BRAIN GLIOMAS, A PHASE III TYPE STUDY
16 Years
N/A
Both
Brain and Central Nervous System Tumors
Trial Information
EFFECT OF DIBROMODULCITOL PLUS BCNU ON FREE INTERVAL AND SURVIVAL OF PATIENTS WITH SUPRATENTORIAL MALIGNANT BRAIN GLIOMAS, A PHASE III TYPE STUDY
OBJECTIVES: I. Compare the disease-free interval and survival in patients with
supratentorial malignant brain gliomas randomized to radiotherapy alone vs. radiotherapy
plus radiosensitization with mitolactol (DBD) followed by DBD and carmustine.
OUTLINE: Randomized study. Group I: Radiotherapy. External-beam cranial irradiation with
megavoltage equipment. Group II: Radiotherapy with Radiosensitization followed by
Maintenance Chemotherapy. Radiotherapy as in Group I; with Mitolactol, DBD, NSC-104800;
followed by DBD; Carmustine, BCNU, NSC-409962.
PROJECTED ACCRUAL: A total of 212 patients will be entered over more than 3 years.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically confirmed anaplastic astrocytoma Standard maximum
resection or stereotactic biopsy required within 4 weeks prior to therapy
PATIENT CHARACTERISTICS: Age: Over 16 Performance status: ECOG/ZUBROD/WHO 0-2 Life
expectancy: At least 8 weeks Hematopoietic: WBC greater than 4,000 Platelets greater than
100,000 Hematocrit greater than 30% Hepatic: Bilirubin less than 2 mg/dl Renal: Creatinine
less than 1.5 mg/dl Creatinine clearance greater than 70 ml/min BUN less than 40 mg/dl
Other: No major medical illness
PRIOR CONCURRENT THERAPY: No anticancer drugs between surgery and protocol treatment No
steroids after 10 days following surgery (may be resumed occasionally during radiotherapy)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
J. Hildebrand, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Hopital Universitaire Erasme
Authority:
United States: Federal Government
Study ID:
EORTC-26882
NCT ID:
NCT00002620
Start Date:
November 1994
Completion Date:
Related Keywords:
- Brain and Central Nervous System Tumors
- adult anaplastic astrocytoma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
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