Radiation Therapy in Treating Patients With Brain Cancer

Phase 3

Completed

• Conditions: Brain and Central Nervous System Tumors

• Registration Number: NCT00002620
• Lead Sponsor: 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.

Study Timeline

• Study Start: 1994-11
• Study First Submitted: 1999-11-01
• Primary Completion: 2000-06
• Study First Submitted QC: 2004-07-16
• Study First Posted: 2004-07-19
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-29
• Last Update Posted: 2012-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 212

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (14)

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland

Kaiser Franz Josef Hospital; 🇦🇹 Vienna (Wien), Austria

Nottingham City Hospital NHS Trust; 🇬🇧 Nottingham, England, United Kingdom

Academisch Ziekenhuis der Vrije Universiteit Brussel; 🇧🇪 Brussels (Bruxelles), Belgium

Hopital Universitaire Erasme; 🇧🇪 Brussels, Belgium

Hopital Civil de Charleroi; 🇧🇪 Charleroi, Belgium

Centre Hospitalier Regional de la Citadell; 🇧🇪 Liege (Luik), Belgium

Neurologische Klinik der Henriettenstiftung; 🇩🇪 Hannover, Germany

Regional Hospital Treviso; 🇮🇹 Treviso, Italy

Rotterdam Cancer Institute; 🇳🇱 Rotterdam, Netherlands

Dr. Bernard Verbeeten Instituut; 🇳🇱 Tilburg, Netherlands

Academisch Ziekenhuis Utrecht; 🇳🇱 Utrecht, Netherlands

Instituto Portugues de Oncologia de Francisco Gentil; 🇵🇹 Lisbon, Portugal

Southampton General Hospital; 🇬🇧 Southampton, England, United Kingdom