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
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|
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|
|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|
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
|Kaiser Franz Josef Hospital|
|Vienna (Wien), Austria, A-1100|
|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|
|Neurologische Klinik der Henriettenstiftung|
|Hannover, Germany, D-30559|
|Regional Hospital Treviso|
|Treviso, Italy, 31100|
|Rotterdam Cancer Institute|
|Rotterdam, Netherlands, 3075 EA|
|Dr. Bernard Verbeeten Instituut|
|Tilburg, Netherlands, 5042 SB|
|Academisch Ziekenhuis Utrecht|
|Utrecht, Netherlands, 3508 GA|
|Instituto Portugues de Oncologia de Francisco Gentil|
|Lisbon, Portugal, 1093|
|Centre Hospitalier Universitaire Vaudois|
|Lausanne, Switzerland, CH-1011|
|Nottingham City Hospital NHS Trust|
|Nottingham, England, United Kingdom, NG5 1PB|
|Southampton General Hospital|
|Southampton, England, United Kingdom, SO16 6YD|
|Study Chair:||J. Hildebrand, MD||Erasme University Hospital|