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Radiation Therapy in Treating Patients With Brain Cancer

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ClinicalTrials.gov Identifier: NCT00002620
Recruitment Status : Completed
First Posted : July 19, 2004
Last Update Posted : July 2, 2012
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment 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

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 212 participants
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
Study Start Date : November 1994
Actual Primary Completion Date : June 2000

Resource links provided by the National Library of Medicine

U.S. FDA Resources





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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)


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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002620


Locations
Austria
Kaiser Franz Josef Hospital
Vienna (Wien), Austria, A-1100
Belgium
Academisch Ziekenhuis der Vrije Universiteit Brussel
Brussels (Bruxelles), Belgium, 1090
Hopital Universitaire Erasme
Brussels, Belgium, 1070
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
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: J. Hildebrand, MD Erasme University Hospital

Publications of Results:
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00002620     History of Changes
Other Study ID Numbers: EORTC-26882
First Posted: July 19, 2004    Key Record Dates
Last Update Posted: July 2, 2012
Last Verified: June 2012

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
Antineoplastic Agents