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

Sponsors

Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Source European Organisation for Research and Treatment of Cancer - EORTC
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.

Overall Status Completed
Start Date 1994-11-01
Primary Completion Date 2000-06-01
Phase Phase 3
Study Type Interventional
Enrollment 212
Condition
Intervention

Intervention Type: Drug

Intervention Name: carmustine

Intervention Type: Drug

Intervention Name: chemotherapy

Intervention Type: Drug

Intervention Name: mitolactol

Intervention Type: Radiation

Intervention Name: low-LET cobalt-60 gamma ray therapy

Intervention Type: Radiation

Intervention Name: low-LET photon therapy

Eligibility

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)

Gender:

All

Minimum Age:

16 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
J. Hildebrand, MD Study Chair Erasme University Hospital
Location
Facility:
Kaiser Franz Josef Hospital | Vienna (Wien), A-1100, Austria
Academisch Ziekenhuis der Vrije Universiteit Brussel | Brussels (Bruxelles), 1090, Belgium
Hopital Universitaire Erasme | Brussels, 1070, Belgium
Hopital Civil de Charleroi | Charleroi, 6000, Belgium
Centre Hospitalier Regional de la Citadell | Liege (Luik), 4000, Belgium
Neurologische Klinik der Henriettenstiftung | Hannover, D-30559, Germany
Regional Hospital Treviso | Treviso, 31100, Italy
Rotterdam Cancer Institute | Rotterdam, 3075 EA, Netherlands
Dr. Bernard Verbeeten Instituut | Tilburg, 5042 SB, Netherlands
Academisch Ziekenhuis Utrecht | Utrecht, 3508 GA, Netherlands
Instituto Portugues de Oncologia de Francisco Gentil | Lisbon, 1093, Portugal
Centre Hospitalier Universitaire Vaudois | Lausanne, CH-1011, Switzerland
Nottingham City Hospital NHS Trust | Nottingham, England, NG5 1PB, United Kingdom
Southampton General Hospital | Southampton, England, SO16 6YD, United Kingdom
Location Countries

Austria

Belgium

Germany

Italy

Netherlands

Portugal

Switzerland

United Kingdom

Verification Date

2012-06-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Allocation: Randomized

Primary Purpose: Treatment

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