- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002620
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
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.
Study Overview
Status
Conditions
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
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Vienna (Wien), Austria, A-1100
- Kaiser Franz Josef Hospital
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Brussels, Belgium, 1070
- Hopital Universitaire Erasme
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Brussels (Bruxelles), Belgium, 1090
- Academisch Ziekenhuis der Vrije Universiteit Brussel
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Charleroi, Belgium, 6000
- Hopital Civil de Charleroi
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Liege (Luik), Belgium, 4000
- Centre Hospitalier Regional de la Citadell
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Hannover, Germany, D-30559
- Neurologische Klinik der Henriettenstiftung
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Treviso, Italy, 31100
- Regional Hospital Treviso
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Rotterdam, Netherlands, 3075 EA
- Rotterdam Cancer Institute
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Tilburg, Netherlands, 5042 SB
- Dr. Bernard Verbeeten Instituut
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Utrecht, Netherlands, 3508 GA
- Academisch Ziekenhuis Utrecht
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Lisbon, Portugal, 1093
- Instituto Portugues de Oncologia de Francisco Gentil
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Lausanne, Switzerland, CH-1011
- Centre Hospitalier Universitaire Vaudois
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England
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Nottingham, England, United Kingdom, NG5 1PB
- Nottingham City Hospital NHS Trust
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Southampton, England, United Kingdom, SO16 6YD
- Southampton General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
Collaborators and Investigators
Investigators
- Study Chair: J. Hildebrand, MD, Erasme University Hospital
Publications and helpful links
General Publications
- Hildebrand J, Gorlia T, Kros JM, Afra D, Frenay M, Omuro A, Stupp R, Lacombe D, Allgeier A, van den Bent MJ; EORTC Brain Tumour Group investigators. Adjuvant dibromodulcitol and BCNU chemotherapy in anaplastic astrocytoma: results of a randomised European Organisation for Research and Treatment of Cancer phase III study (EORTC study 26882). Eur J Cancer. 2008 Jun;44(9):1210-6. doi: 10.1016/j.ejca.2007.12.005. Epub 2008 Jan 14.
- Hildebrand J, Sahmoud T, Mignolet F, Brucher JM, Afra D. Adjuvant therapy with dibromodulcitol and BCNU increases survival of adults with malignant gliomas. EORTC Brain Tumor Group. Neurology. 1994 Aug;44(8):1479-83. doi: 10.1212/wnl.44.8.1479.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms
- Neoplasms by Site
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Trace Elements
- Micronutrients
- Carmustine
- Cobalt
- Mitolactol
Other Study ID Numbers
- EORTC-26882
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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