Nctid:
NCT00002696
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-27"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D001943", "term"=>"Breast Neoplasms"}], "ancestors"=>[{"id"=>"D009371", "term"=>"Neoplasms by Site"}, {"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D001941", "term"=>"Breast Diseases"}, {"id"=>"D012871", "term"=>"Skin Diseases"}], "browseLeaves"=>[{"id"=>"M5220", "name"=>"Breast Neoplasms", "asFound"=>"Breast Cancer", "relevance"=>"HIGH"}, {"id"=>"M5218", "name"=>"Breast Diseases", "relevance"=>"LOW"}, {"id"=>"M15674", "name"=>"Skin Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D003520", "term"=>"Cyclophosphamide"}, {"id"=>"D004317", "term"=>"Doxorubicin"}, {"id"=>"C506643", "term"=>"Liposomal doxorubicin"}, {"id"=>"D005472", "term"=>"Fluorouracil"}, {"id"=>"D008727", "term"=>"Methotrexate"}], "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"=>"D000963", "term"=>"Antimetabolites"}, {"id"=>"D000964", "term"=>"Antimetabolites, Antineoplastic"}, {"id"=>"D000020", "term"=>"Abortifacient Agents, Nonsteroidal"}, {"id"=>"D000019", "term"=>"Abortifacient Agents"}, {"id"=>"D012102", "term"=>"Reproductive Control Agents"}, {"id"=>"D003879", "term"=>"Dermatologic Agents"}, {"id"=>"D005493", "term"=>"Folic Acid Antagonists"}, {"id"=>"D019384", "term"=>"Nucleic Acid Synthesis Inhibitors"}], "browseLeaves"=>[{"id"=>"M8600", "name"=>"Fluorouracil", "asFound"=>"Outcomes", "relevance"=>"HIGH"}, {"id"=>"M7492", "name"=>"Doxorubicin", "asFound"=>"Arterial", "relevance"=>"HIGH"}, {"id"=>"M227339", "name"=>"Liposomal doxorubicin", "asFound"=>"Arterial", "relevance"=>"HIGH"}, {"id"=>"M6727", "name"=>"Cyclophosphamide", "asFound"=>"Was", "relevance"=>"HIGH"}, {"id"=>"M11703", "name"=>"Methotrexate", "asFound"=>"Positive", "relevance"=>"HIGH"}, {"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"=>"M4281", "name"=>"Antimetabolites", "relevance"=>"LOW"}, {"id"=>"M7074", "name"=>"Dermatologic Agents", "relevance"=>"LOW"}, {"id"=>"M17546", "name"=>"Vitamin B Complex", "relevance"=>"LOW"}, {"id"=>"M8618", "name"=>"Folic Acid", "relevance"=>"LOW"}, {"id"=>"M8619", "name"=>"Folic Acid Antagonists", "relevance"=>"LOW"}, {"id"=>"T447", "name"=>"Folinic Acid", "relevance"=>"LOW"}, {"id"=>"T446", "name"=>"Folic Acid", "relevance"=>"LOW"}, {"id"=>"T448", "name"=>"Folate", "relevance"=>"LOW"}, {"id"=>"T475", "name"=>"Vitamin B9", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Antirheumatic Agents", "abbrev"=>"ARhu"}, {"name"=>"Dermatologic Agents", "abbrev"=>"Derm"}, {"name"=>"Reproductive Control Agents", "abbrev"=>"Repr"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"Micronutrients", "abbrev"=>"Micro"}, {"name"=>"Hematinics", "abbrev"=>"Hemat"}, {"name"=>"Vitamins", "abbrev"=>"Vi"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "primaryPurpose"=>"TREATMENT"}}, "statusModule"=>{"overallStatus"=>"SUSPENDED", "startDateStruct"=>{"date"=>"1995-10"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2008-04", "lastUpdateSubmitDate"=>"2013-08-01", "studyFirstSubmitDate"=>"1999-11-01", "studyFirstSubmitQcDate"=>"2003-01-26", "lastUpdatePostDateStruct"=>{"date"=>"2013-08-02", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2003-01-27", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["stage IIIA breast cancer", "stage IIIB breast cancer", "stage IIIC breast cancer"], "conditions"=>["Breast Cancer"]}, "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 may kill more tumor cells.\n\nPURPOSE: Randomized phase III trial to compare cyclophosphamide, doxorubicin, and fluorouracil with cyclophosphamide, methotrexate, and fluorouracil in treating women with stage III breast cancer.", "detailedDescription"=>"OBJECTIVES:\n\n* Compare the response in women with stage III breast cancer treated with neoadjuvant fluorouracil, doxorubicin, and cyclophosphamide (FAC) vs cyclophosphamide, methotrexate, and fluorouracil (CMF).\n* Compare the rates of conservative surgical resectability and locoregional control in patients treated with these neoadjuvant therapy regimens.\n* Compare the disease-free and overall survival of patients treated with these regimens.\n* Compare the toxic effects of these regimens in these patients.\n* Compare the compliance of patients treated with these regimens.\n* Assess the cosmetic results in patients treated with conservative surgery.\n* Compare the quality of life of patients treated with these regimens.\n\nOUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center.\n\n* Arm I: Patients receive fluorouracil (5-FU) IV on days 1 and 8 and doxorubicin IV and cyclophosphamide (CTX) IV on day 1 (FAC). Treatment continues every 3 weeks for 3 courses in the absence of disease progression.\n* Arm II: Patients receive CTX IV, methotrexate IV, and 5-FU IV on days 1 and 8 (CMF). Treatment continues every 4 weeks for 3 courses in the absence of disease progression.\n\nPatients on both arms with resectable disease after the third course of chemotherapy undergo quadrantectomy with axillary node dissection (preferred) or modified radical mastectomy, followed by 6 additional courses of chemotherapy on the arm to which they were randomized initially. Those patients without distant metastasis undergo locoregional radiotherapy beginning concurrently with the initiation of postoperative chemotherapy. Patients on both arms with unresectable disease after the initial 3 courses of chemotherapy undergo locoregional radiotherapy and then surgical resection (if feasible).\n\nQuality of life is assessed at baseline and then monthly thereafter.\n\nPatients are followed every 3-4 months for 2 years, every 4-6 months for 3 years, and then annually thereafter.\n\nPROJECTED ACCRUAL: Not specified"}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"75 years", "minimumAge"=>"21 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"DISEASE CHARACTERISTICS:\n\n* Histologically confirmed stage III breast cancer\n* Measurable disease\n* No inflammatory breast cancer\n* No synchronous bilateral breast cancer\n* Hormone receptor status:\n\n * Not specified\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 21 to 75\n\nSex:\n\n* Female\n\nMenopausal status:\n\n* Not specified\n\nPerformance status:\n\n* ECOG 0-1 OR\n* Zubrod 0-1\n\nLife expectancy:\n\n* More than 12 weeks\n\nHematopoietic:\n\n* WBC greater than 4,000/mm\\^3\n* Platelet count greater than 100,000/mm\\^3\n\nHepatic:\n\n* Bilirubin less than 1.25 times upper limit of normal (ULN)\n* AST less than 1.25 times ULN\n\nRenal:\n\n* Creatinine clearance greater than 70 mL/min\n\nCardiovascular:\n\n* No angina pectoris\n* No significant arrhythmia requiring therapy\n* No bilateral bundle branch block\n* No congestive heart failure\n* No myocardial infarction\n\nOther:\n\n* No medical or psychiatric disease that would preclude study therapy\n* No other malignancy except adequately treated nonmelanomatous skin cancer or carcinoma in situ of the cervix\n* Not pregnant\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* Not specified\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* No prior radiotherapy\n\nSurgery:\n\n* No prior surgery except incisional biopsy or fine-needle aspiration\n\nOther:\n\n* No prior systemic therapy\n* No concurrent caffeine or alcohol"}, "identificationModule"=>{"nctId"=>"NCT00002696", "briefTitle"=>"Combination Chemotherapy in Treating Women With Stage III Breast Cancer", "organization"=>{"class"=>"NIH", "fullName"=>"National Cancer Institute (NCI)"}, "officialTitle"=>"MULTIMODALITY TREATMENT STRATEGY FOR STAGE III BREAST CANCER", "orgStudyIdInfo"=>{"id"=>"GOCS-08-BR-95-III"}, "secondaryIdInfos"=>[{"id"=>"CDR0000064471", "type"=>"REGISTRY", "domain"=>"PDQ (Physician Data Query)"}, {"id"=>"NCI-F95-0036"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"CAF regimen", "type"=>"DRUG"}, {"name"=>"CMF regimen", "type"=>"DRUG"}, {"name"=>"cyclophosphamide", "type"=>"DRUG"}, {"name"=>"doxorubicin hydrochloride", "type"=>"DRUG"}, {"name"=>"fluorouracil", "type"=>"DRUG"}, {"name"=>"methotrexate", "type"=>"DRUG"}, {"name"=>"adjuvant therapy", "type"=>"PROCEDURE"}, {"name"=>"conventional surgery", "type"=>"PROCEDURE"}, {"name"=>"neoadjuvant therapy", "type"=>"PROCEDURE"}, {"name"=>"radiation therapy", "type"=>"RADIATION"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"8000", "city"=>"Bahia Blanca", "state"=>"Buenos Aires", "country"=>"Argentina", "facility"=>"Policlinica Privada Instituto De Medicina Nuclear", "geoPoint"=>{"lat"=>-38.71959, "lon"=>-62.27243}}, {"zip"=>"7600", "city"=>"Mar del Plata", "state"=>"Buenos Aires", "country"=>"Argentina", "facility"=>"Consultorio Oncologico Privado", "geoPoint"=>{"lat"=>-38.00228, "lon"=>-57.55754}}, {"zip"=>"6300", "city"=>"Santa Rosa", "state"=>"La Pampa", "country"=>"Argentina", "facility"=>"Centro De Oncologia y Terapia Radiante", "geoPoint"=>{"lat"=>-36.61667, "lon"=>-64.28333}}, {"city"=>"Neuquen", "country"=>"Argentina", "facility"=>"Unidad Oncologica Del Comahue", "geoPoint"=>{"lat"=>-38.95161, "lon"=>-68.0591}}, {"zip"=>"9400", "city"=>"Rio Gallegos", "country"=>"Argentina", "facility"=>"Consultorio Oncologico Privado", "geoPoint"=>{"lat"=>-51.62261, "lon"=>-69.21813}}, {"zip"=>"3000", "city"=>"Santa Fe", "country"=>"Argentina", "facility"=>"Centro Oncologico Del Litoral", "geoPoint"=>{"lat"=>-31.63333, "lon"=>-60.7}}, {"zip"=>"7500", "city"=>"Tres Arroyos", "country"=>"Argentina", "facility"=>"Centro Oncologico Tres Arroyos", "geoPoint"=>{"lat"=>-38.37394, "lon"=>-60.27978}}], "overallOfficials"=>[{"name"=>"Bernardo A. Leone, MD", "role"=>"STUDY_CHAIR", "affiliation"=>"Unidad Oncologica Del Neuquen"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Grupo Oncologico Cooperativo del Sur", "class"=>"OTHER"}}}}
