Nctid:
NCT00002620
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-11-01"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D009423", "term"=>"Nervous System Neoplasms"}, {"id"=>"D016543", "term"=>"Central Nervous System Neoplasms"}], "ancestors"=>[{"id"=>"D009371", "term"=>"Neoplasms by Site"}, {"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D009422", "term"=>"Nervous System Diseases"}], "browseLeaves"=>[{"id"=>"M5209", "name"=>"Brain Neoplasms", "relevance"=>"LOW"}, {"id"=>"M9020", "name"=>"Glioma", "relevance"=>"LOW"}, {"id"=>"M4561", "name"=>"Astrocytoma", "relevance"=>"LOW"}, {"id"=>"M12367", "name"=>"Nervous System Neoplasms", "asFound"=>"Nervous System Tumors", "relevance"=>"HIGH"}, {"id"=>"M18937", "name"=>"Central Nervous System Neoplasms", "asFound"=>"Central Nervous System Tumors", "relevance"=>"HIGH"}, {"id"=>"T2519", "name"=>"Glioma", "relevance"=>"LOW"}, {"id"=>"T364", "name"=>"Anaplastic Astrocytoma", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D003035", "term"=>"Cobalt"}, {"id"=>"D002330", "term"=>"Carmustine"}, {"id"=>"D008936", "term"=>"Mitolactol"}], "ancestors"=>[{"id"=>"D018906", "term"=>"Antineoplastic Agents, Alkylating"}, {"id"=>"D000477", "term"=>"Alkylating Agents"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D014131", "term"=>"Trace Elements"}, {"id"=>"D018977", "term"=>"Micronutrients"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}], "browseLeaves"=>[{"id"=>"M6265", "name"=>"Cobalt", "asFound"=>"Measles", "relevance"=>"HIGH"}, {"id"=>"M5585", "name"=>"Carmustine", "asFound"=>"Classification", "relevance"=>"HIGH"}, {"id"=>"M11902", "name"=>"Mitolactol", "asFound"=>"Conrol", "relevance"=>"HIGH"}, {"id"=>"M20942", "name"=>"Antineoplastic Agents, Alkylating", "relevance"=>"LOW"}, {"id"=>"M3820", "name"=>"Alkylating Agents", "relevance"=>"LOW"}, {"id"=>"M21009", "name"=>"Micronutrients", "relevance"=>"LOW"}, {"id"=>"M16885", "name"=>"Trace Elements", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Micronutrients", "abbrev"=>"Micro"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>212}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1994-11"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2012-06", "lastUpdateSubmitDate"=>"2012-06-29", "studyFirstSubmitDate"=>"1999-11-01", "studyFirstSubmitQcDate"=>"2004-07-16", "lastUpdatePostDateStruct"=>{"date"=>"2012-07-02", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2004-07-19", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"2000-06", "type"=>"ACTUAL"}}, "conditionsModule"=>{"keywords"=>["adult anaplastic astrocytoma"], "conditions"=>["Brain and Central Nervous System Tumors"]}, "referencesModule"=>{"references"=>[{"pmid"=>"18248979", "type"=>"RESULT", "citation"=>"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."}, {"pmid"=>"8058153", "type"=>"RESULT", "citation"=>"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."}]}, "descriptionModule"=>{"briefSummary"=>"RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be an effective treatment for patients with anaplastic astrocytomas.\n\nPURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy in treating patients with anaplastic astrocytomas.", "detailedDescription"=>"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.\n\nOUTLINE: 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.\n\nPROJECTED ACCRUAL: A total of 212 patients will be entered over more than 3 years."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"16 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"DISEASE CHARACTERISTICS: Histologically confirmed anaplastic astrocytoma Standard maximum resection or stereotactic biopsy required within 4 weeks prior to therapy\n\nPATIENT 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\n\nPRIOR CONCURRENT THERAPY: No anticancer drugs between surgery and protocol treatment No steroids after 10 days following surgery (may be resumed occasionally during radiotherapy)"}, "identificationModule"=>{"nctId"=>"NCT00002620", "briefTitle"=>"Radiation Therapy in Treating Patients With Brain Cancer", "organization"=>{"class"=>"NETWORK", "fullName"=>"European Organisation for Research and Treatment of Cancer - EORTC"}, "officialTitle"=>"EFFECT OF DIBROMODULCITOL PLUS BCNU ON FREE INTERVAL AND SURVIVAL OF PATIENTS WITH SUPRATENTORIAL MALIGNANT BRAIN GLIOMAS, A PHASE III TYPE STUDY", "orgStudyIdInfo"=>{"id"=>"EORTC-26882"}, "secondaryIdInfos"=>[{"id"=>"EORTC-26882"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"carmustine", "type"=>"DRUG"}, {"name"=>"chemotherapy", "type"=>"DRUG"}, {"name"=>"mitolactol", "type"=>"DRUG"}, {"name"=>"low-LET cobalt-60 gamma ray therapy", "type"=>"RADIATION"}, {"name"=>"low-LET photon therapy", "type"=>"RADIATION"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"A-1100", "city"=>"Vienna (Wien)", "country"=>"Austria", "facility"=>"Kaiser Franz Josef Hospital", "geoPoint"=>{"lat"=>48.20849, "lon"=>16.37208}}, {"zip"=>"1090", "city"=>"Brussels (Bruxelles)", "country"=>"Belgium", "facility"=>"Academisch Ziekenhuis der Vrije Universiteit Brussel", "geoPoint"=>{"lat"=>50.85045, "lon"=>4.34878}}, {"zip"=>"1070", "city"=>"Brussels", "country"=>"Belgium", "facility"=>"Hopital Universitaire Erasme", "geoPoint"=>{"lat"=>50.85045, "lon"=>4.34878}}, {"zip"=>"6000", "city"=>"Charleroi", "country"=>"Belgium", "facility"=>"Hopital Civil de Charleroi", "geoPoint"=>{"lat"=>50.41136, "lon"=>4.44448}}, {"zip"=>"4000", "city"=>"Liege (Luik)", "country"=>"Belgium", "facility"=>"Centre Hospitalier Regional de la Citadell"}, {"zip"=>"D-30559", "city"=>"Hannover", "country"=>"Germany", "facility"=>"Neurologische Klinik der Henriettenstiftung", "geoPoint"=>{"lat"=>52.37052, "lon"=>9.73322}}, {"zip"=>"31100", "city"=>"Treviso", "country"=>"Italy", "facility"=>"Regional Hospital Treviso", "geoPoint"=>{"lat"=>45.66673, "lon"=>12.2416}}, {"zip"=>"3075 EA", "city"=>"Rotterdam", "country"=>"Netherlands", "facility"=>"Rotterdam Cancer Institute", "geoPoint"=>{"lat"=>51.9225, "lon"=>4.47917}}, {"zip"=>"5042 SB", "city"=>"Tilburg", "country"=>"Netherlands", "facility"=>"Dr. Bernard Verbeeten Instituut", "geoPoint"=>{"lat"=>51.55551, "lon"=>5.0913}}, {"zip"=>"3508 GA", "city"=>"Utrecht", "country"=>"Netherlands", "facility"=>"Academisch Ziekenhuis Utrecht", "geoPoint"=>{"lat"=>52.09083, "lon"=>5.12222}}, {"zip"=>"1093", "city"=>"Lisbon", "country"=>"Portugal", "facility"=>"Instituto Portugues de Oncologia de Francisco Gentil", "geoPoint"=>{"lat"=>38.71667, "lon"=>-9.13333}}, {"zip"=>"CH-1011", "city"=>"Lausanne", "country"=>"Switzerland", "facility"=>"Centre Hospitalier Universitaire Vaudois", "geoPoint"=>{"lat"=>46.516, "lon"=>6.63282}}, {"zip"=>"NG5 1PB", "city"=>"Nottingham", "state"=>"England", "country"=>"United Kingdom", "facility"=>"Nottingham City Hospital NHS Trust", "geoPoint"=>{"lat"=>52.9536, "lon"=>-1.15047}}, {"zip"=>"SO16 6YD", "city"=>"Southampton", "state"=>"England", "country"=>"United Kingdom", "facility"=>"Southampton General Hospital", "geoPoint"=>{"lat"=>50.90395, "lon"=>-1.40428}}], "overallOfficials"=>[{"name"=>"J. Hildebrand, MD", "role"=>"STUDY_CHAIR", "affiliation"=>"Erasme University Hospital"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"European Organisation for Research and Treatment of Cancer - EORTC", "class"=>"NETWORK"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}