Nctid:
NCT00002822
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2025-01-02"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D008175", "term"=>"Lung Neoplasms"}, {"id"=>"D055752", "term"=>"Small Cell Lung Carcinoma"}], "ancestors"=>[{"id"=>"D012142", "term"=>"Respiratory Tract Neoplasms"}, {"id"=>"D013899", "term"=>"Thoracic Neoplasms"}, {"id"=>"D009371", "term"=>"Neoplasms by Site"}, {"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D008171", "term"=>"Lung Diseases"}, {"id"=>"D012140", "term"=>"Respiratory Tract Diseases"}, {"id"=>"D002283", "term"=>"Carcinoma, Bronchogenic"}, {"id"=>"D001984", "term"=>"Bronchial Neoplasms"}], "browseLeaves"=>[{"id"=>"M11172", "name"=>"Lung Neoplasms", "asFound"=>"Lung Cancer", "relevance"=>"HIGH"}, {"id"=>"M28323", "name"=>"Small Cell Lung Carcinoma", "asFound"=>"Small Cell Lung Cancer", "relevance"=>"HIGH"}, {"id"=>"M5534", "name"=>"Carcinoma", "relevance"=>"LOW"}, {"id"=>"M14979", "name"=>"Respiratory Tract Neoplasms", "relevance"=>"LOW"}, {"id"=>"M16658", "name"=>"Thoracic Neoplasms", "relevance"=>"LOW"}, {"id"=>"M11168", "name"=>"Lung Diseases", "relevance"=>"LOW"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "relevance"=>"LOW"}, {"id"=>"M5540", "name"=>"Carcinoma, Bronchogenic", "relevance"=>"LOW"}, {"id"=>"M5260", "name"=>"Bronchial Neoplasms", "relevance"=>"LOW"}, {"id"=>"T5271", "name"=>"Small Cell Lung Cancer", "asFound"=>"Small Cell Lung Cancer", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D003520", "term"=>"Cyclophosphamide"}, {"id"=>"D007069", "term"=>"Ifosfamide"}, {"id"=>"D016190", "term"=>"Carboplatin"}, {"id"=>"D004317", "term"=>"Doxorubicin"}, {"id"=>"C506643", "term"=>"Liposomal doxorubicin"}, {"id"=>"D005047", "term"=>"Etoposide"}, {"id"=>"D014750", "term"=>"Vincristine"}], "ancestors"=>[{"id"=>"D007166", "term"=>"Immunosuppressive Agents"}, {"id"=>"D007155", "term"=>"Immunologic Factors"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D018501", "term"=>"Antirheumatic Agents"}, {"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"=>"D019653", "term"=>"Myeloablative Agonists"}, {"id"=>"D000903", "term"=>"Antibiotics, Antineoplastic"}, {"id"=>"D059005", "term"=>"Topoisomerase II Inhibitors"}, {"id"=>"D059003", "term"=>"Topoisomerase Inhibitors"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D000972", "term"=>"Antineoplastic Agents, Phytogenic"}, {"id"=>"D050257", "term"=>"Tubulin Modulators"}, {"id"=>"D050256", "term"=>"Antimitotic Agents"}, {"id"=>"D050258", "term"=>"Mitosis Modulators"}], "browseLeaves"=>[{"id"=>"M8191", "name"=>"Etoposide", "asFound"=>"Different", "relevance"=>"HIGH"}, {"id"=>"M18650", "name"=>"Carboplatin", "asFound"=>"Followed", "relevance"=>"HIGH"}, {"id"=>"M7492", "name"=>"Doxorubicin", "asFound"=>"State", "relevance"=>"HIGH"}, {"id"=>"M227339", "name"=>"Liposomal doxorubicin", "asFound"=>"State", "relevance"=>"HIGH"}, {"id"=>"M6182", "name"=>"Cisplatin", "relevance"=>"LOW"}, {"id"=>"M6727", "name"=>"Cyclophosphamide", "asFound"=>"Was", "relevance"=>"HIGH"}, {"id"=>"M17495", "name"=>"Vincristine", "asFound"=>"Molecular", "relevance"=>"HIGH"}, {"id"=>"M341643", "name"=>"Etoposide phosphate", "relevance"=>"LOW"}, {"id"=>"M10117", "name"=>"Ifosfamide", "asFound"=>"Route", "relevance"=>"HIGH"}, {"id"=>"M230811", "name"=>"Isophosphamide mustard", "relevance"=>"LOW"}, {"id"=>"M17811", "name"=>"Mesna", "relevance"=>"LOW"}, {"id"=>"M10212", "name"=>"Immunosuppressive Agents", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}, {"id"=>"M20604", "name"=>"Antirheumatic Agents", "relevance"=>"LOW"}, {"id"=>"M20942", "name"=>"Antineoplastic Agents, Alkylating", "relevance"=>"LOW"}, {"id"=>"M3820", "name"=>"Alkylating Agents", "relevance"=>"LOW"}, {"id"=>"M4222", "name"=>"Anti-Bacterial Agents", "relevance"=>"LOW"}, {"id"=>"M4224", "name"=>"Antibiotics, Antitubercular", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M26197", "name"=>"Tubulin Modulators", "relevance"=>"LOW"}, {"id"=>"M26196", "name"=>"Antimitotic Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Antirheumatic Agents", "abbrev"=>"ARhu"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>400}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1996-03"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2000-12", "completionDateStruct"=>{"date"=>"2005-11", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2013-12-18", "studyFirstSubmitDate"=>"1999-11-01", "studyFirstSubmitQcDate"=>"2003-04-15", "lastUpdatePostDateStruct"=>{"date"=>"2013-12-19", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2003-04-16", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["limited stage small cell lung cancer", "extensive stage small cell lung cancer"], "conditions"=>["Lung Cancer"]}, "referencesModule"=>{"references"=>[{"pmid"=>"16293867", "type"=>"RESULT", "citation"=>"Thatcher N, Qian W, Clark PI, Hopwood P, Sambrook RJ, Owens R, Stephens RJ, Girling DJ. Ifosfamide, carboplatin, and etoposide with midcycle vincristine versus standard chemotherapy in patients with small-cell lung cancer and good performance status: clinical and quality-of-life results of the British Medical Research Council multicenter randomized LU21 trial. J Clin Oncol. 2005 Nov 20;23(33):8371-9. doi: 10.1200/JCO.2004.00.9969."}, {"type"=>"RESULT", "citation"=>"Thatcher N, Qian W, Girling DJ: Ifosfamide, carboplatin and etoposide with mid-cycle vincristine (ICE-V) versus standard chemotherapy (C) in patients with small cell lung cancer (SCLC) and good performance status (PS): results of an MRC randomized trial (LU21). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2489, 619, 2003."}]}, "descriptionModule"=>{"briefSummary"=>"RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug is a way to kill more tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells.\n\nPURPOSE: Randomized phase III trial to compare the effect of two combination chemotherapy regimens followed by radiation therapy in treating patients with small cell lung cancer.", "detailedDescription"=>"OBJECTIVES:\n\n* Compare the survival rate in patients with newly diagnosed small cell lung cancer and good performance status treated with an intensive regimen of ifosfamide/carboplatin/etoposide with mid-cycle vincristine (VICE) vs. standard chemotherapy followed, as feasible, by thoracic radiotherapy.\n* Compare the adverse effects of treatment and quality of life (including psychological distress, physical status, and functional status and global quality of life) in these patients.\n* Compare the Rotterdam Symptom Checklist vs. the EORTC QLQ-C30 and LC13 quality-of-life questionnaires in relation to compliance and ability to detect differences between treatments.\n\nOUTLINE: This is a randomized study.\n\nThe first group receives standard combination chemotherapy with doxorubicin/cyclophosphamide/etoposide (ACE) or cisplatin/etoposide (PE) every 3 weeks for 6 courses.\n\nThe second group receives intensive combination chemotherapy with carboplatin/ifosfamide/etoposide on days 1-3 with vincristine on day 14 (VICE). Courses repeat every 4 weeks for 6 courses.\n\nPatients in both groups are considered for thoracic radiotherapy beginning 4-5 weeks after the first day of the last course of chemotherapy.\n\nConcurrent prophylactic antibiotics should be given. Patients who relapse may receive further treatment at the clinician's option.\n\nPatients are followed monthly for 6 months, every 2 months for up to 1 year, every 3 months for up to 2 years, every 6 months for 5 years, and annually thereafter.\n\nPROJECTED ACCRUAL: A total of 400 patients will be entered over 3 years."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"DISEASE CHARACTERISTICS:\n\n* Microscopically proven small cell lung cancer\n\n * Diagnosis based on bronchial, mediastinal, pleural, lung, or lymph node biopsy, sputum cytology, or bronchial brushing or fine needle aspirate cytology\n * No pleural fluid cytology\n* No prior therapy\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* Any age\n\nPerformance status:\n\n* WHO 0-2\n\nHematopoietic:\n\n* WBC more than 3,000\n* ANC more than 1,500\n* Platelets more than 100,000\n\nHepatic/Renal:\n\n* Alkaline phosphatase, aminotransferase, sodium, and LDH normal or no more than 1 of them abnormal\n* Creatinine or urea normal\n* Creatinine clearance or GFR more than 65 mL/min\n\nOther:\n\n* No clinical evidence of infection\n* No prior or concurrent malignancy that interferes with protocol treatments or comparisons\n* No other condition that contraindicates treatment\n* Willing and able to complete quality-of-life questionnaires\n\n * Hospital Anxiety and Depression Scale, Rotterdam Symptom Checklist, and EORTC questionnaires completed prior to randomization\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* See Disease Characteristics\n\nChemotherapy:\n\n* See Disease Characteristics\n\nEndocrine therapy:\n\n* See Disease Characteristics\n\nRadiotherapy:\n\n* See Disease Characteristics\n\nSurgery:\n\n* See Disease Characteristics"}, "identificationModule"=>{"nctId"=>"NCT00002822", "briefTitle"=>"Combination Chemotherapy Followed by Radiation Therapy in Patients With Small Cell Lung Cancer", "organization"=>{"class"=>"NIH", "fullName"=>"National Cancer Institute (NCI)"}, "officialTitle"=>"RANDOMISED CLINICAL TRIAL OF IFOSFAMIDE, CARBOPLATIN AND ETOPOSIDE WITH MID-CYCLE VINCRISTINE (VICE) VERSUS STANDARD PRACTICE CHEMOTHERAPY IN PATIENTS WITH LIMITED STAGE SMALL CELL LUNG CANCER (SCLC) AND GOOD PERFORMANCE STATUS", "orgStudyIdInfo"=>{"id"=>"CDR0000064998"}, "secondaryIdInfos"=>[{"id"=>"MRC-LU21"}, {"id"=>"EU-96019"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"carboplatin", "type"=>"DRUG"}, {"name"=>"cisplatin", "type"=>"DRUG"}, {"name"=>"cyclophosphamide", "type"=>"DRUG"}, {"name"=>"doxorubicin hydrochloride", "type"=>"DRUG"}, {"name"=>"etoposide", "type"=>"DRUG"}, {"name"=>"ifosfamide", "type"=>"DRUG"}, {"name"=>"mesna", "type"=>"DRUG"}, {"name"=>"vincristine sulfate", "type"=>"DRUG"}, {"name"=>"radiation therapy", "type"=>"RADIATION"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"NW1 2DA", "city"=>"London", "state"=>"England", "country"=>"United Kingdom", "facility"=>"Medical Research Council Clinical Trials Unit", "geoPoint"=>{"lat"=>51.50853, "lon"=>-0.12574}}], "overallOfficials"=>[{"name"=>"David J. Girling, MD", "role"=>"STUDY_CHAIR", "affiliation"=>"Medical Research Council"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Medical Research Council", "class"=>"OTHER_GOV"}}}}