Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT00002620
Status:
COMPLETED
Last Update Posted:
2012-07-02
First Post:
1999-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Radiation Therapy in Treating Patients With Brain Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D001254', 'term': 'Astrocytoma'}], 'ancestors': [{'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002330', 'term': 'Carmustine'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D008936', 'term': 'Mitolactol'}], 'ancestors': [{'id': 'D009607', 'term': 'Nitrosourea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009603', 'term': 'Nitroso Compounds'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004376', 'term': 'Galactitol'}, {'id': 'D013402', 'term': 'Sugar Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, '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': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Hopital Universitaire Erasme', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1090', 'city': 'Brussels (Bruxelles)', 'country': 'Belgium', 'facility': 'Academisch Ziekenhuis der Vrije Universiteit Brussel', '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', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': 'D-30559', 'city': 'Hanover', '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': 38.72509, 'lon': -9.1498}}, {'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'}}}}