Nctid:
NCT00002545
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D005909", "term"=>"Glioblastoma"}, {"id"=>"D009423", "term"=>"Nervous System Neoplasms"}, {"id"=>"D016543", "term"=>"Central Nervous System Neoplasms"}], "ancestors"=>[{"id"=>"D001254", "term"=>"Astrocytoma"}, {"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"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D009375", "term"=>"Neoplasms, Glandular and Epithelial"}, {"id"=>"D009380", "term"=>"Neoplasms, Nerve Tissue"}, {"id"=>"D009371", "term"=>"Neoplasms by Site"}, {"id"=>"D009422", "term"=>"Nervous System Diseases"}], "browseLeaves"=>[{"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"=>"M9019", "name"=>"Glioblastoma", "asFound"=>"Glioblastoma", "relevance"=>"HIGH"}, {"id"=>"M20460", "name"=>"Gliosarcoma", "relevance"=>"LOW"}, {"id"=>"M4561", "name"=>"Astrocytoma", "relevance"=>"LOW"}, {"id"=>"M9020", "name"=>"Glioma", "relevance"=>"LOW"}, {"id"=>"M20446", "name"=>"Neoplasms, Neuroepithelial", "relevance"=>"LOW"}, {"id"=>"M19845", "name"=>"Neuroectodermal Tumors", "relevance"=>"LOW"}, {"id"=>"M20388", "name"=>"Neuroectodermal Tumors, Primitive", "relevance"=>"LOW"}, {"id"=>"M12318", "name"=>"Neoplasms, Germ Cell and Embryonal", "relevance"=>"LOW"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M12320", "name"=>"Neoplasms, Glandular and Epithelial", "relevance"=>"LOW"}, {"id"=>"M12325", "name"=>"Neoplasms, Nerve Tissue", "relevance"=>"LOW"}, {"id"=>"T2518", "name"=>"Glioblastoma", "asFound"=>"Glioblastoma", "relevance"=>"HIGH"}, {"id"=>"T2522", "name"=>"Gliosarcoma", "relevance"=>"LOW"}, {"id"=>"T2519", "name"=>"Glioma", "relevance"=>"LOW"}, {"id"=>"T4092", "name"=>"Neuroepithelioma", "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"=>"D002330", "term"=>"Carmustine"}], "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"}], "browseLeaves"=>[{"id"=>"M5585", "name"=>"Carmustine", "asFound"=>"Classification", "relevance"=>"HIGH"}, {"id"=>"M20942", "name"=>"Antineoplastic Agents, Alkylating", "relevance"=>"LOW"}, {"id"=>"M3820", "name"=>"Alkylating Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>200}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1994-02"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2013-08", "lastUpdateSubmitDate"=>"2013-08-09", "studyFirstSubmitDate"=>"1999-11-01", "studyFirstSubmitQcDate"=>"2004-07-16", "lastUpdatePostDateStruct"=>{"date"=>"2013-08-13", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2004-07-19", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"2004-12", "type"=>"ACTUAL"}}, "oversightModule"=>{"oversightHasDmc"=>true}, "conditionsModule"=>{"keywords"=>["adult glioblastoma", "adult giant cell glioblastoma", "adult gliosarcoma"], "conditions"=>["Brain and Central Nervous System Tumors"]}, "referencesModule"=>{"references"=>[{"pmid"=>"18817556", "type"=>"BACKGROUND", "citation"=>"Chinnaiyan P, Wang M, Rojiani AM, Tofilon PJ, Chakravarti A, Ang KK, Zhang HZ, Hammond E, Curran W Jr, Mehta MP. The prognostic value of nestin expression in newly diagnosed glioblastoma: report from the Radiation Therapy Oncology Group. Radiat Oncol. 2008 Sep 25;3:32. doi: 10.1186/1748-717X-3-32."}, {"type"=>"BACKGROUND", "citation"=>"Seiferheld W, Chakravarti A, Ang KK, et al.: Overexpression of the epidermal growth factor receptor (EGFR), as determined by EGFR immunostaining on tissue microarrays, fails to demonstrate prognostic value for patients with glioblastoma multiforme: a report from RTOG 7401, 7918, 8302, 8409, 9006, 9305, 9602, and 9806. [Abstract] Int J Radiat Oncol Biol Phys 54(2 suppl 1): A-166, 616, 2002."}, {"pmid"=>"20383558", "type"=>"RESULT", "citation"=>"Anker CJ, Hymas RV, Hazard LJ, Boucher KM, Jensen RL, Shrieve DC. Stereotactic radiosurgery eligibility and selection bias in the treatment of glioblastoma multiforme. J Neurooncol. 2010 Jun;98(2):253-63. doi: 10.1007/s11060-010-0176-y. Epub 2010 Apr 10."}, {"pmid"=>"15890570", "type"=>"RESULT", "citation"=>"Chakravarti A, Seiferheld W, Tu X, Wang H, Zhang HZ, Ang KK, Hammond E, Curran W Jr, Mehta M. Immunohistochemically determined total epidermal growth factor receptor levels not of prognostic value in newly diagnosed glioblastoma multiforme: report from the Radiation Therapy Oncology Group. Int J Radiat Oncol Biol Phys. 2005 Jun 1;62(2):318-27. doi: 10.1016/j.ijrobp.2004.10.037."}, {"pmid"=>"15465203", "type"=>"RESULT", "citation"=>"Souhami L, Seiferheld W, Brachman D, Podgorsak EB, Werner-Wasik M, Lustig R, Schultz CJ, Sause W, Okunieff P, Buckner J, Zamorano L, Mehta MP, Curran WJ Jr. Randomized comparison of stereotactic radiosurgery followed by conventional radiotherapy with carmustine to conventional radiotherapy with carmustine for patients with glioblastoma multiforme: report of Radiation Therapy Oncology Group 93-05 protocol. Int J Radiat Oncol Biol Phys. 2004 Nov 1;60(3):853-60. doi: 10.1016/j.ijrobp.2004.04.011."}, {"type"=>"RESULT", "citation"=>"Souhami L, Scott C, Brachman D, et al.: Randomized prospective comparison of stereotactic radiosurgery (SRS) followed by conventional radiotherapy (RT) with BCNU to RT with BCNU alone for selected patients with supratentorial glioblastoma multiforme (GBM): report of RTOG 93-05 protocol. [Abstract] Int J Radiat Oncol Biol Phys 54(2 suppl 1): A-163, 94-95, 2002."}]}, "descriptionModule"=>{"briefSummary"=>"RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Chemotherapy uses different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.\n\nPURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy and carmustine in treating patients who have supratentorial glioblastoma multiforme.", "detailedDescription"=>"OBJECTIVES: I. Determine whether the use of radiosurgery (stereotactic external-beam irradiation) prior to conventional radiotherapy with carmustine (BCNU) improves overall survival compared to conventional radiotherapy plus BCNU alone in patients with supratentorial glioblastoma multiforme. II. Determine and compare the frequency and severity of toxicities associated with these regimens. III. Compare the effects of these two regimens on neurologic function and quality of life.\n\nOUTLINE: Randomized study. Arm I: Radiotherapy plus Single-Agent Chemotherapy. Tumor irradiation using megavoltage equipment (at least 4 MV photons); plus Carmustine, BCNU, NSC-409962. Arm II: Radiosurgery followed by Radiotherapy plus Single-Agent Chemotherapy. Stereotactic tumor irradiation; followed by tumor irradiation as in Arm I; plus BCNU.\n\nPROJECTED ACCRUAL: 200 patients will be entered over approximately 3 years."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"DISEASE CHARACTERISTICS: Histopathologically confirmed supratentorial glioblastoma multiforme or gliosarcoma Diagnosis by surgical biopsy or resection required The following tumor types are specifically excluded: Astrocytoma with atypical or anaplastic features Well differentiated astrocytomas Tumors originating in the brain stem Tumors located within 10 mm of the optic chiasm Infratentorial tumors Multifocal malignant glioma Recurrent malignant glioma Well circumscribed contrast-enhancing tumor on pre- and postoperative contrast-enhanced CT or MRI with a maximum diameter (in any direction) of 40 mm required Tumors that do not enhance on postoperative CT or MRI excluded Concurrent enrollment on RTOG-9308 encouraged\n\nPATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 3 months Hematopoietic: ANC at least 1,500 Platelets at least 100,000 Hb at least 10 g/dl (may transfuse) Hepatic: Bilirubin no greater than 2.0 mg/dl SGOT or SGPT no greater than 2 x normal Renal: Creatinine no greater than 1.5 mg/dl BUN no greater than 25 mg/dl Pulmonary: Chest x-ray normal If abnormal or if there is a history of pulmonary disease, pulmonary function studies (including DLCO) must be at least 75% of predicted Other: Neurologic function status 0-3 No AIDS No major medical or psychiatric illness that would preclude protocol therapy or follow-up No second malignancy within 5 years except: Nonmelanomatous skin cancer In situ carcinoma of the uterine cervix\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the head and neck Surgery: No more than 5 weeks between surgery and initiation of treatment Recovery from surgery and any postoperative complications required"}, "identificationModule"=>{"nctId"=>"NCT00002545", "briefTitle"=>"Radiation Therapy Plus Chemotherapy in Treating Patients With Supratentorial Glioblastoma Multiforme", "organization"=>{"class"=>"NETWORK", "fullName"=>"Radiation Therapy Oncology Group"}, "officialTitle"=>"A PHASE III TRIAL COMPARING THE USE OF RADIOSURGERY FOLLOWED BY CONVENTIONAL RADIOTHERAPY WITH BCNU TO CONVENTIONAL RADIOTHERAPY WITH BCNU FOR SUPRATENTORIAL GLIOBLASTOMA MULTIFORME", "orgStudyIdInfo"=>{"id"=>"RTOG-9305"}, "secondaryIdInfos"=>[{"id"=>"CDR0000063286"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"carmustine", "type"=>"DRUG"}, {"name"=>"low-LET photon therapy", "type"=>"RADIATION"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"35233", "city"=>"Birmingham", "state"=>"Alabama", "country"=>"United States", "facility"=>"Veterans Affairs Medical Center - Birmingham", "geoPoint"=>{"lat"=>33.52066, "lon"=>-86.80249}}, {"zip"=>"35294", "city"=>"Birmingham", "state"=>"Alabama", "country"=>"United States", "facility"=>"University of Alabama Comprehensive Cancer Center", "geoPoint"=>{"lat"=>33.52066, "lon"=>-86.80249}}, {"zip"=>"35801", "city"=>"Huntsville", "state"=>"Alabama", "country"=>"United States", "facility"=>"Huntsville Hospital System", "geoPoint"=>{"lat"=>34.7304, "lon"=>-86.58594}}, {"zip"=>"36640", "city"=>"Mobile", "state"=>"Alabama", "country"=>"United States", "facility"=>"Urology Associates - Mobile AL", "geoPoint"=>{"lat"=>30.69436, "lon"=>-88.04305}}, {"zip"=>"36688", "city"=>"Mobile", "state"=>"Alabama", "country"=>"United States", "facility"=>"MBCCOP - University of South Alabama", "geoPoint"=>{"lat"=>30.69436, "lon"=>-88.04305}}, {"zip"=>"36106-2801", "city"=>"Montgomery", "state"=>"Alabama", "country"=>"United States", "facility"=>"Alabama Oncology, LLC", "geoPoint"=>{"lat"=>32.36681, "lon"=>-86.29997}}, {"zip"=>"35401", "city"=>"Tuscallosa", "state"=>"Alabama", "country"=>"United States", "facility"=>"Radiation Oncology Associates of West Alabama", "geoPoint"=>{"lat"=>33.20984, "lon"=>-87.56917}}, {"zip"=>"99508", "city"=>"Anchorage", "state"=>"Alaska", "country"=>"United States", "facility"=>"Providence Cancer Therapy Center", "geoPoint"=>{"lat"=>61.21806, "lon"=>-149.90028}}, {"zip"=>"85001-2071", "city"=>"Phoenix", "state"=>"Arizona", "country"=>"United States", "facility"=>"St. Joseph's Hospital and Medical Center", "geoPoint"=>{"lat"=>33.44838, "lon"=>-112.07404}}, {"zip"=>"85724", "city"=>"Tucson", "state"=>"Arizona", "country"=>"United States", "facility"=>"Arizona Cancer Center", "geoPoint"=>{"lat"=>32.22174, "lon"=>-110.92648}}, {"zip"=>"91505", "city"=>"Burbank", "state"=>"California", "country"=>"United States", "facility"=>"Providence Saint Joseph Medical Center - 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Mount Sinai Medical Center", "geoPoint"=>{"lat"=>25.79065, "lon"=>-80.13005}}, {"zip"=>"33136", "city"=>"Miami", "state"=>"Florida", "country"=>"United States", "facility"=>"Sylvester Cancer Center, University of Miami", "geoPoint"=>{"lat"=>25.77427, "lon"=>-80.19366}}, {"zip"=>"33176-2197", "city"=>"Miami", "state"=>"Florida", "country"=>"United States", "facility"=>"Baptist Hospital of Miami", "geoPoint"=>{"lat"=>25.77427, "lon"=>-80.19366}}, {"zip"=>"32073", "city"=>"Orange Park", "state"=>"Florida", "country"=>"United States", "facility"=>"Florida Radiation Oncology Group", "geoPoint"=>{"lat"=>30.16607, "lon"=>-81.70648}}, {"zip"=>"32806", "city"=>"Orlando", "state"=>"Florida", "country"=>"United States", "facility"=>"MD Anderson Cancer Center Orlando", "geoPoint"=>{"lat"=>28.53834, "lon"=>-81.37924}}, {"zip"=>"32405-4587", "city"=>"Panama City", "state"=>"Florida", "country"=>"United States", "facility"=>"Gulf Coast Cancer Treatment Center", "geoPoint"=>{"lat"=>30.15946, "lon"=>-85.65983}}, {"zip"=>"32514", "city"=>"Pensacola", "state"=>"Florida", "country"=>"United States", "facility"=>"West Florida Cancer Institute - 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