Radiation Therapy in Treating Patients With Brain Cancer
NCT ID: NCT00002620
Last Updated: 2012-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
212 participants
INTERVENTIONAL
1994-11-30
Brief Summary
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PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy in treating patients with anaplastic astrocytomas.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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carmustine
chemotherapy
mitolactol
low-LET cobalt-60 gamma ray therapy
low-LET photon therapy
Eligibility Criteria
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Inclusion Criteria
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)
16 Years
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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J. Hildebrand, MD
Role: STUDY_CHAIR
Erasme University Hospital
Locations
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Kaiser Franz Josef Hospital
Vienna (Wien), , Austria
Hopital Universitaire Erasme
Brussels, , Belgium
Academisch Ziekenhuis der Vrije Universiteit Brussel
Brussels (Bruxelles), , Belgium
Hopital Civil de Charleroi
Charleroi, , Belgium
Centre Hospitalier Regional de la Citadell
Liege (Luik), , Belgium
Neurologische Klinik der Henriettenstiftung
Hanover, , 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
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom
Southampton General Hospital
Southampton, England, United Kingdom
Countries
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References
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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.
Other Identifiers
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EORTC-26882
Identifier Type: -
Identifier Source: secondary_id
EORTC-26882
Identifier Type: -
Identifier Source: org_study_id
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