Radiation Therapy in Treating Patients With Brain Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: carmustine Drug: chemotherapy Drug: mitolactol Radiation: low-LET cobalt-60 gamma ray therapy Radiation: low-LET photon therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | EFFECT OF DIBROMODULCITOL PLUS BCNU ON FREE INTERVAL AND SURVIVAL OF PATIENTS WITH SUPRATENTORIAL MALIGNANT BRAIN GLIOMAS, A PHASE III TYPE STUDY |
| Estimated Enrollment: | 212 |
| Study Start Date: | November 1994 |
| Primary Completion Date: | June 2000 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations| Austria | |
| Kaiser Franz Josef Hospital | |
| Vienna (Wien), Austria, A-1100 | |
| Belgium | |
| Hopital Universitaire Erasme | |
| Brussels, Belgium, 1070 | |
| Academisch Ziekenhuis der Vrije Universiteit Brussel | |
| Brussels (Bruxelles), Belgium, 1090 | |
| Hopital Civil de Charleroi | |
| Charleroi, Belgium, 6000 | |
| Centre Hospitalier Regional de la Citadell | |
| Liege (Luik), Belgium, 4000 | |
| Germany | |
| Neurologische Klinik der Henriettenstiftung | |
| Hannover, Germany, D-30559 | |
| Italy | |
| Regional Hospital Treviso | |
| Treviso, Italy, 31100 | |
| Netherlands | |
| Rotterdam Cancer Institute | |
| Rotterdam, Netherlands, 3075 EA | |
| Dr. Bernard Verbeeten Instituut | |
| Tilburg, Netherlands, 5042 SB | |
| Academisch Ziekenhuis Utrecht | |
| Utrecht, Netherlands, 3508 GA | |
| Portugal | |
| Instituto Portugues de Oncologia de Francisco Gentil | |
| Lisbon, Portugal, 1093 | |
| Switzerland | |
| Centre Hospitalier Universitaire Vaudois | |
| Lausanne, Switzerland, CH-1011 | |
| United Kingdom | |
| Nottingham City Hospital NHS Trust | |
| Nottingham, England, United Kingdom, NG5 1PB | |
| Southampton General Hospital | |
| Southampton, England, United Kingdom, SO16 6YD | |
| Study Chair: | J. Hildebrand, MD | Hopital Universitaire Erasme |
More Information
Additional Information:
Publications:
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00002620 History of Changes |
| Other Study ID Numbers: | EORTC-26882, EORTC-26882 |
| Study First Received: | November 1, 1999 |
| Last Updated: | June 29, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
|
adult anaplastic astrocytoma |
Additional relevant MeSH terms:
|
Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms by Site Neoplasms Nervous System Diseases Carmustine Mitolactol |
Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013