EFFECT OF DIBROMODULCITOL PLUS BCNU ON FREE INTERVAL AND SURVIVAL OF PATIENTS WITH SUPRATENTORIAL MALIGNANT BRAIN GLIOMAS, A PHASE III TYPE STUDY


Phase 3
16 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

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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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