Trials / Completed
CompletedNCT00002620
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
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 212 (estimated)
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC · Network
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | carmustine | |
| DRUG | chemotherapy | |
| DRUG | mitolactol | |
| RADIATION | low-LET cobalt-60 gamma ray therapy | |
| RADIATION | low-LET photon therapy |
Timeline
- Start date
- 1994-11-01
- Primary completion
- 2000-06-01
- First posted
- 2004-07-19
- Last updated
- 2012-07-02
Locations
14 sites across 8 countries: Austria, Belgium, Germany, Italy, Netherlands, Portugal, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT00002620. Inclusion in this directory is not an endorsement.