Radiation Therapy in Treating Patients With Brain Cancer

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002620

Enrollment

212

Registered

2004-07-19

Start date

1994-11-30

Completion date

Unknown

Last updated

2012-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain and Central Nervous System Tumors

Keywords

adult anaplastic astrocytoma

Brief summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be an effective treatment for patients with anaplastic astrocytomas. PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy in treating patients with anaplastic astrocytomas.

Detailed description

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.

Interventions

DRUGcarmustine

DRUGchemotherapy

DRUGmitolactol

RADIATIONlow-LET cobalt-60 gamma ray therapy

RADIATIONlow-LET photon therapy

Study design

Allocation

RANDOMIZED

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

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)

Countries

Austria, Belgium, Germany, Italy, Netherlands, Portugal, Switzerland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026