Nctid:
NCT00002490
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D001749", "term"=>"Urinary Bladder Neoplasms"}], "ancestors"=>[{"id"=>"D014571", "term"=>"Urologic Neoplasms"}, {"id"=>"D014565", "term"=>"Urogenital Neoplasms"}, {"id"=>"D009371", "term"=>"Neoplasms by Site"}, {"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D052776", "term"=>"Female Urogenital Diseases"}, {"id"=>"D005261", "term"=>"Female Urogenital Diseases and Pregnancy Complications"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D001745", "term"=>"Urinary Bladder Diseases"}, {"id"=>"D014570", "term"=>"Urologic Diseases"}, {"id"=>"D052801", "term"=>"Male Urogenital Diseases"}], "browseLeaves"=>[{"id"=>"M5534", "name"=>"Carcinoma", "relevance"=>"LOW"}, {"id"=>"M5551", "name"=>"Carcinoma, Transitional Cell", "relevance"=>"LOW"}, {"id"=>"M5030", "name"=>"Urinary Bladder Neoplasms", "asFound"=>"Bladder Cancer", "relevance"=>"HIGH"}, {"id"=>"M17320", "name"=>"Urologic Neoplasms", "relevance"=>"LOW"}, {"id"=>"M17315", "name"=>"Urogenital Neoplasms", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M27093", "name"=>"Female Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M14127", "name"=>"Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M8399", "name"=>"Female Urogenital Diseases and Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M5026", "name"=>"Urinary Bladder Diseases", "relevance"=>"LOW"}, {"id"=>"M17319", "name"=>"Urologic Diseases", "relevance"=>"LOW"}, {"id"=>"M27095", "name"=>"Male Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"T5693", "name"=>"Transitional Cell Carcinoma", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D008937", "term"=>"Mitomycins"}, {"id"=>"D016685", "term"=>"Mitomycin"}, {"id"=>"D001500", "term"=>"BCG Vaccine"}], "ancestors"=>[{"id"=>"D000903", "term"=>"Antibiotics, Antineoplastic"}, {"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D000477", "term"=>"Alkylating Agents"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D019384", "term"=>"Nucleic Acid Synthesis Inhibitors"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D000276", "term"=>"Adjuvants, Immunologic"}, {"id"=>"D007155", "term"=>"Immunologic Factors"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}], "browseLeaves"=>[{"id"=>"M17360", "name"=>"Vaccines", "relevance"=>"LOW"}, {"id"=>"M11903", "name"=>"Mitomycins", "asFound"=>"Awareness", "relevance"=>"HIGH"}, {"id"=>"M19053", "name"=>"Mitomycin", "asFound"=>"Awareness", "relevance"=>"HIGH"}, {"id"=>"M4793", "name"=>"BCG Vaccine", "asFound"=>"Sulfonylurea", "relevance"=>"HIGH"}, {"id"=>"M4222", "name"=>"Anti-Bacterial Agents", "relevance"=>"LOW"}, {"id"=>"M4224", "name"=>"Antibiotics, Antitubercular", "relevance"=>"LOW"}, {"id"=>"M3820", "name"=>"Alkylating Agents", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M3628", "name"=>"Adjuvants, Immunologic", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "primaryPurpose"=>"TREATMENT"}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1991-09"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2001-06", "lastUpdateSubmitDate"=>"2013-12-17", "studyFirstSubmitDate"=>"1999-11-01", "studyFirstSubmitQcDate"=>"2003-01-26", "lastUpdatePostDateStruct"=>{"date"=>"2013-12-18", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2003-01-27", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["stage I bladder cancer", "transitional cell carcinoma of the bladder"], "conditions"=>["Bladder Cancer"]}, "referencesModule"=>{"references"=>[{"type"=>"RESULT", "citation"=>"Harland SJ: A randomised trial of radical radiotherapy in pT1G3 NXM0 bladder cancer (MRC BS06). [Abstract] J Clin Oncol 23 (Suppl 16): A-4505, 379s, 2005."}]}, "descriptionModule"=>{"briefSummary"=>"RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not known whether receiving either radiation therapy, chemotherapy, or observation is more effective for cancer of the bladder.\n\nPURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy, chemotherapy, or observation following tumor surgery in treating patients who have bladder cancer.", "detailedDescription"=>"OBJECTIVES:\n\n* Compare the efficacy of adjuvant radical radiotherapy vs intravesical BCG or mitomycin vs observation alone after endoscopic resection in terms of the progression rate and survival of patients with stage I, grade 3 transitional cell carcinoma of the bladder.\n* Determine the toxicity of radical radiotherapy in these patients.\n* Determine the incidence of carcinoma in situ elsewhere in the bladder and its correlation with the subsequent clinical outcome of these patients.\n\nOUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, extent of tumor (single tumor without carcinoma in situ (CIS) vs multiple tumors or CIS), and WHO performance status. Patients with a single tumor and no CIS are randomized to arm I or II. Patients with multiple tumors or CIS are randomized to arm II or III.\n\n* Arm I: Patients undergo observation only.\n* Arm II: Patients undergo radical radiotherapy 5 days a week for 6 weeks. Patients found to be node positive on CT scan may undergo pelvic irradiation and remain on study.\n* Arm III: Patients receive intravesical BCG or mitomycin (at the discretion of the physician) weekly for 6-12 weeks.\n\nPatients on arms I and III are followed at 3 months after randomization. All patients are followed at 6, 9, and 12 months and then annually thereafter.\n\nPROJECTED ACCRUAL: A total of 200 patients will be accrued for this study."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"DISEASE CHARACTERISTICS:\n\n* Diagnosis of transitional cell carcinoma of the bladder\n\n * Stage T1 Nx M0, grade 3 disease\n * No muscle invasion at base of tumor\n * Diagnosis of this stage made within the past 6 months\n\n * Earlier diagnosis of tumors with lower stage or grade allowed\n * No history of higher stage urothelial tumors\n* Presence of partial involvement of bladder with carcinoma in situ (CIS) or asymptomatic widespread CIS allowed\n\n * No widespread CIS causing severe symptoms\n* Prior complete transurethral resection of tumor with deep biopsy of underlying bladder wall required\n* Disease currently amenable to adjuvant radiotherapy, followed by cystoscopy with biopsies\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* Any age\n\nPerformance status:\n\n* WHO 0-2\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Not specified\n\nHepatic:\n\n* Not specified\n\nRenal:\n\n* Not specified\n\nOther:\n\n* No other prior or concurrent malignancy except nonmelanomatous skin cancer or cervical intraepithelial neoplasia\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No more than 1 prior adjuvant treatment with intravesical BCG\n\nChemotherapy:\n\n* No more than 1 prior adjuvant treatment with intravesical chemotherapy\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* See Disease Characteristics\n\nSurgery:\n\n* See Disease Characteristics\n* Diathermic removal of associated small papillary growths allowed"}, "identificationModule"=>{"nctId"=>"NCT00002490", "briefTitle"=>"Radiation Therapy, Chemotherapy, or Observation in Treating Patients With Bladder Cancer", "organization"=>{"class"=>"NIH", "fullName"=>"National Cancer Institute (NCI)"}, "officialTitle"=>"A RANDOMIZED TRIAL OF RADICAL RADIOTHERAPY IN pT1G3 NXM0 BLADDER CANCER", "orgStudyIdInfo"=>{"id"=>"CDR0000077404"}, "secondaryIdInfos"=>[{"id"=>"MRC-BS06"}, {"id"=>"EU-91019"}, {"id"=>"ISRCTN65282717"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"BCG vaccine", "type"=>"BIOLOGICAL"}, {"name"=>"mitomycin C", "type"=>"DRUG"}, {"name"=>"radiation therapy", "type"=>"RADIATION"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"WIT 3AA", "city"=>"London", "state"=>"England", "country"=>"United Kingdom", "facility"=>"Middlesex Hospital- Meyerstein Institute", "geoPoint"=>{"lat"=>51.50853, "lon"=>-0.12574}}], "overallOfficials"=>[{"name"=>"Stephen J. Harland, MD", "role"=>"STUDY_CHAIR", "affiliation"=>"University College London Hospitals"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Medical Research Council", "class"=>"OTHER_GOV"}}}}
