Nctid:
NCT00002568
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-11-01"}, "conditionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M3585", "name"=>"Adenocarcinoma", "relevance"=>"LOW"}, {"id"=>"M5534", "name"=>"Carcinoma", "relevance"=>"LOW"}, {"id"=>"M12307", "name"=>"Neoplasm Metastasis", "relevance"=>"LOW"}, {"id"=>"M12974", "name"=>"Ovarian Neoplasms", "relevance"=>"LOW"}, {"id"=>"M1704", "name"=>"Carcinoma, Ovarian Epithelial", "relevance"=>"LOW"}, {"id"=>"M20429", "name"=>"Cystadenocarcinoma, Serous", "relevance"=>"LOW"}, {"id"=>"M6741", "name"=>"Cystadenocarcinoma", "relevance"=>"LOW"}, {"id"=>"M5225", "name"=>"Brenner Tumor", "relevance"=>"LOW"}, {"id"=>"M20427", "name"=>"Cystadenocarcinoma, Mucinous", "relevance"=>"LOW"}, {"id"=>"T4352", "name"=>"Ovarian Cancer", "asFound"=>"Ovarian Cancer", "relevance"=>"HIGH"}, {"id"=>"T4354", "name"=>"Ovarian Epithelial Cancer", "asFound"=>"Ovarian epithelial cancer", "relevance"=>"HIGH"}, {"id"=>"T200", "name"=>"Adenocarcinoma of the Appendix", "relevance"=>"LOW"}, {"id"=>"T862", "name"=>"Brenner Tumor of Ovary", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Gland and Hormone Related Diseases", "abbrev"=>"BC19"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D017239", "term"=>"Paclitaxel"}, {"id"=>"D002945", "term"=>"Cisplatin"}], "ancestors"=>[{"id"=>"D000972", "term"=>"Antineoplastic Agents, Phytogenic"}, {"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D050257", "term"=>"Tubulin Modulators"}, {"id"=>"D050256", "term"=>"Antimitotic Agents"}, {"id"=>"D050258", "term"=>"Mitosis Modulators"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}], "browseLeaves"=>[{"id"=>"M19537", "name"=>"Paclitaxel", "asFound"=>"Training", "relevance"=>"HIGH"}, {"id"=>"M6182", "name"=>"Cisplatin", "asFound"=>"Health", "relevance"=>"HIGH"}, {"id"=>"M231", "name"=>"Albumin-Bound Paclitaxel", "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"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>470}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1994-06"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2010-05", "lastUpdateSubmitDate"=>"2013-07-08", "studyFirstSubmitDate"=>"1999-11-01", "studyFirstSubmitQcDate"=>"2004-05-04", "lastUpdatePostDateStruct"=>{"date"=>"2013-07-09", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2004-05-05", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"2004-12", "type"=>"ACTUAL"}}, "conditionsModule"=>{"keywords"=>["stage III ovarian epithelial cancer", "ovarian undifferentiated adenocarcinoma", "ovarian mixed epithelial carcinoma", "ovarian serous cystadenocarcinoma", "ovarian mucinous cystadenocarcinoma", "ovarian endometrioid adenocarcinoma", "ovarian clear cell cystadenocarcinoma", "Brenner tumor"], "conditions"=>["Ovarian Cancer"]}, "referencesModule"=>{"references"=>[{"pmid"=>"20471545", "type"=>"BACKGROUND", "citation"=>"von Gruenigen VE, Huang HQ, Gil KM, Gibbons HE, Monk BJ, Rose PG, Armstrong DK, Cella D, Wenzel L. A comparison of quality-of-life domains and clinical factors in ovarian cancer patients: a Gynecologic Oncology Group study. J Pain Symptom Manage. 2010 May;39(5):839-46. doi: 10.1016/j.jpainsymman.2009.09.022."}, {"pmid"=>"19536873", "type"=>"BACKGROUND", "citation"=>"Farley JH, Tian C, Rose GS, Brown CL, Birrer M, Maxwell GL. Race does not impact outcome for advanced ovarian cancer patients treated with cisplatin/paclitaxel: an analysis of Gynecologic Oncology Group trials. Cancer. 2009 Sep 15;115(18):4210-7. doi: 10.1002/cncr.24482."}, {"pmid"=>"18025437", "type"=>"BACKGROUND", "citation"=>"Winter WE 3rd, Maxwell GL, Tian C, Sundborg MJ, Rose GS, Rose PG, Rubin SC, Muggia F, McGuire WP; Gynecologic Oncology Group. Tumor residual after surgical cytoreduction in prediction of clinical outcome in stage IV epithelial ovarian cancer: a Gynecologic Oncology Group Study. J Clin Oncol. 2008 Jan 1;26(1):83-9. doi: 10.1200/JCO.2007.13.1953. Epub 2007 Nov 19."}, {"pmid"=>"17704411", "type"=>"BACKGROUND", "citation"=>"Winter WE 3rd, Maxwell GL, Tian C, Carlson JW, Ozols RF, Rose PG, Markman M, Armstrong DK, Muggia F, McGuire WP; Gynecologic Oncology Group Study. Prognostic factors for stage III epithelial ovarian cancer: a Gynecologic Oncology Group Study. J Clin Oncol. 2007 Aug 20;25(24):3621-7. doi: 10.1200/JCO.2006.10.2517."}, {"pmid"=>"14521806", "type"=>"BACKGROUND", "citation"=>"van der Burg ME, Vergote I; Gynecological Cancer Group of the EORTC. The role of interval debulking surgery in ovarian cancer. Curr Oncol Rep. 2003 Nov;5(6):473-81. doi: 10.1007/s11912-003-0008-8."}, {"pmid"=>"16110020", "type"=>"RESULT", "citation"=>"Wenzel L, Huang HQ, Monk BJ, Rose PG, Cella D. Quality-of-life comparisons in a randomized trial of interval secondary cytoreduction in advanced ovarian carcinoma: a Gynecologic Oncology Group study. J Clin Oncol. 2005 Aug 20;23(24):5605-12. doi: 10.1200/JCO.2005.08.147."}, {"pmid"=>"30633128", "type"=>"DERIVED", "citation"=>"Rose PG, Java JJ, Salani R, Geller MA, Secord AA, Tewari KS, Bender DP, Mutch DG, Friedlander ML, Van Le L, Method MW, Hamilton CA, Lee RB, Wenham RM, Guntupalli SR, Markman M, Muggia FM, Armstrong DK, Bookman MA, Burger RA, Copeland LJ. Nomogram for Predicting Individual Survival After Recurrence of Advanced-Stage, High-Grade Ovarian Carcinoma. Obstet Gynecol. 2019 Feb;133(2):245-254. doi: 10.1097/AOG.0000000000003086. Erratum In: Obstet Gynecol. 2019 Apr;133(4):830. doi: 10.1097/AOG.0000000000003212."}]}, "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 or combining chemotherapy with surgery may kill more tumor cells.\n\nPURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy consisting of paclitaxel and cisplatin with or without surgery in treating patients with stage III ovarian epithelial cancer.", "detailedDescription"=>"OBJECTIVES: I. Determine whether secondary cytoreductive surgery improves the progression-free interval and survival in patients with suboptimally resected stage III ovarian epithelial carcinoma treated with paclitaxel/cisplatin. II. Determine the morbidity of secondary cytoreductive surgery in these patients. III. Assess prospectively the quality of life (QOL) of these patients and determine whether secondary cytoreductive surgery affects QOL.\n\nOUTLINE: Randomized study. Following treatment on Regimen A, patients with stable or objective response are randomized to Arms I and II. Regimen A: 2-Drug Combination Chemotherapy. Paclitaxel (Bristol-Myers), Taxol, NSC-125973; Cisplatin, CDDP, NSC-119875. Arm I: Surgery followed by 2-Drug Combination Chemotherapy. Laparotomy with resection of residual disease; followed by Taxol/CDDP. Arm II: 2-Drug Combination Chemotherapy. Taxol; CDDP.\n\nPROJECTED ACCRUAL: Approximately 470 patients will be entered over 20 months to provide 400 evaluable patients."}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"DISEASE CHARACTERISTICS: Histologically confirmed primary ovarian epithelial cancer Stage III disease, i.e.: Greater than 1 cm residual intraperitoneal disease following exploratory laparotomy with maximum debulking Laparoscopic resection alone insufficient The following histologies are eligible: Serous adenocarcinoma Transitional cell carcinoma Mucinous adenocarcinoma Undifferentiated carcinoma Clear cell adenocarcinoma Mixed epithelial carcinoma Adenocarcinoma Endometrioid tumor Adenocarcinoma NOS Malignant Brenner's tumor No unclassified ovarian cancer (i.e., unexplored tumors thought to be of ovarian origin or tumors not verified as arising from ovarian stroma) No borderline (grade 0) or \"probably malignant\" carcinoma Measurable disease preferred Patients eligible for this protocol are also eligible for protocol GOG-136\n\nPATIENT CHARACTERISTICS: Age: Any age Performance status: GOG 0-2 Hematopoietic: WBC at least 3,000/mm3 Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no more than 1.5 times normal ALT, AST, and GGT no more than 3 times normal Alkaline phosphatase no more than 3 times normal LDH no more than 3 times normal Renal: Creatinine no more than 2.0 mg/dL Cardiovascular: No history of congestive heart failure No myocardial infarction within 6 months No unstable angina Other: No septicemia or severe infection No acute hepatitis No severe gastrointestinal bleeding No second malignancy within 5 years except nonmelanomatous skin cancer Not pregnant or nursing Effective contraception required of fertile patients\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior cytotoxic chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics No more than 6 weeks since staging surgery"}, "identificationModule"=>{"nctId"=>"NCT00002568", "briefTitle"=>"Combination Chemotherapy With or Without Surgery in Treating Patients With Stage III Ovarian Epithelial Cancer", "organization"=>{"class"=>"NETWORK", "fullName"=>"GOG Foundation"}, "officialTitle"=>"A PHASE III RANDOMIZED STUDY OF CISPLATIN (NSC #119875) AND TAXOL (PACLITAXEL) (NSC #125973) WITH INTERVAL SECONDARY CYTOREDUCTION VERSUS CISPLATIN AND PACLITAXEL IN PATIENTS WITH SUBOPTIMAL STAGE III & IV EPITHELIAL OVARIAN CARCINOMA", "orgStudyIdInfo"=>{"id"=>"CDR0000063600"}, "secondaryIdInfos"=>[{"id"=>"GOG-152"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"cisplatin", "type"=>"DRUG"}, {"name"=>"paclitaxel", "type"=>"DRUG"}, {"name"=>"conventional surgery", "type"=>"PROCEDURE"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"35294", "city"=>"Birmingham", "state"=>"Alabama", "country"=>"United States", "facility"=>"University of Alabama Comprehensive Cancer Center", "geoPoint"=>{"lat"=>33.52066, "lon"=>-86.80249}}, {"zip"=>"85006-2726", "city"=>"Phoenix", "state"=>"Arizona", "country"=>"United States", "facility"=>"CCOP - Greater Phoenix", "geoPoint"=>{"lat"=>33.44838, "lon"=>-112.07404}}, {"zip"=>"90033-0800", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"USC/Norris Comprehensive Cancer Center", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"90095-1781", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Jonsson Comprehensive Cancer Center, UCLA", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"92868", "city"=>"Orange", "state"=>"California", "country"=>"United States", "facility"=>"Chao Family Comprehensive Cancer Center", "geoPoint"=>{"lat"=>33.78779, "lon"=>-117.85311}}, {"zip"=>"94304", "city"=>"Palo Alto", "state"=>"California", "country"=>"United States", "facility"=>"Women's Cancer Center", "geoPoint"=>{"lat"=>37.44188, "lon"=>-122.14302}}, {"zip"=>"94305-5408", "city"=>"Stanford", "state"=>"California", "country"=>"United States", "facility"=>"Stanford University Medical Center", "geoPoint"=>{"lat"=>37.42411, "lon"=>-122.16608}}, {"zip"=>"80262", "city"=>"Denver", "state"=>"Colorado", "country"=>"United States", "facility"=>"University of Colorado Cancer Center", "geoPoint"=>{"lat"=>39.73915, "lon"=>-104.9847}}, {"zip"=>"20007", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"Lombardi Cancer Center, Georgetown University", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"20307-5000", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"Walter Reed Army Medical Center", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"33612", "city"=>"Tampa", "state"=>"Florida", "country"=>"United States", "facility"=>"H. 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Chandler Medical Center, University of Kentucky", "geoPoint"=>{"lat"=>37.98869, "lon"=>-84.47772}}, {"zip"=>"21231", "city"=>"Baltimore", "state"=>"Maryland", "country"=>"United States", "facility"=>"Johns Hopkins Oncology Center", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}, {"zip"=>"01655", "city"=>"Worcester", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"University of Massachusetts Memorial Medical Center", "geoPoint"=>{"lat"=>42.26259, "lon"=>-71.80229}}, {"zip"=>"48106", "city"=>"Ann Arbor", "state"=>"Michigan", "country"=>"United States", "facility"=>"CCOP - Ann Arbor Regional", "geoPoint"=>{"lat"=>42.27756, "lon"=>-83.74088}}, {"zip"=>"48201", "city"=>"Detroit", "state"=>"Michigan", "country"=>"United States", "facility"=>"Barbara Ann Karmanos Cancer Institute", "geoPoint"=>{"lat"=>42.33143, "lon"=>-83.04575}}, {"zip"=>"55455", "city"=>"Minneapolis", "state"=>"Minnesota", "country"=>"United States", "facility"=>"University of Minnesota Cancer Center", "geoPoint"=>{"lat"=>44.97997, "lon"=>-93.26384}}, {"zip"=>"39216-4505", "city"=>"Jackson", "state"=>"Mississippi", "country"=>"United States", "facility"=>"University of Mississippi Medical Center", "geoPoint"=>{"lat"=>32.29876, "lon"=>-90.18481}}, {"zip"=>"63110", "city"=>"Saint Louis", "state"=>"Missouri", "country"=>"United States", "facility"=>"Washington University School of Medicine", "geoPoint"=>{"lat"=>38.62727, "lon"=>-90.19789}}, {"zip"=>"08103", "city"=>"Camden", "state"=>"New Jersey", "country"=>"United States", "facility"=>"Cooper Hospital/University Medical Center", "geoPoint"=>{"lat"=>39.92595, "lon"=>-75.11962}}, {"zip"=>"07962-1956", "city"=>"Morristown", "state"=>"New Jersey", "country"=>"United States", "facility"=>"Morristown Memorial Hospital", "geoPoint"=>{"lat"=>40.79677, "lon"=>-74.48154}}, {"zip"=>"12208", "city"=>"Albany", "state"=>"New York", "country"=>"United States", "facility"=>"Cancer Center of Albany Medical Center", "geoPoint"=>{"lat"=>42.65258, "lon"=>-73.75623}}, {"zip"=>"11203", "city"=>"Brooklyn", "state"=>"New York", "country"=>"United States", "facility"=>"State University of New York Health Science Center at Brooklyn", "geoPoint"=>{"lat"=>40.6501, "lon"=>-73.94958}}, {"zip"=>"11030", "city"=>"Manhasset", "state"=>"New York", "country"=>"United States", "facility"=>"North Shore University Hospital", "geoPoint"=>{"lat"=>40.79788, "lon"=>-73.69957}}, {"zip"=>"10021", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Memorial Sloan-Kettering Cancer Center", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"14642", "city"=>"Rochester", "state"=>"New York", "country"=>"United States", "facility"=>"University of Rochester Cancer Center", "geoPoint"=>{"lat"=>43.15478, "lon"=>-77.61556}}, {"zip"=>"11790-7775", "city"=>"Stony Brook", "state"=>"New York", "country"=>"United States", "facility"=>"State University of New York Health Sciences Center - Stony Brook", "geoPoint"=>{"lat"=>40.92565, "lon"=>-73.14094}}, {"zip"=>"27599-7295", "city"=>"Chapel Hill", "state"=>"North Carolina", "country"=>"United States", "facility"=>"Lineberger Comprehensive Cancer Center, UNC", "geoPoint"=>{"lat"=>35.9132, "lon"=>-79.05584}}, {"zip"=>"27710", "city"=>"Durham", "state"=>"North Carolina", "country"=>"United States", "facility"=>"Duke Comprehensive Cancer Center", "geoPoint"=>{"lat"=>35.99403, "lon"=>-78.89862}}, {"zip"=>"27157-1082", "city"=>"Winston-Salem", "state"=>"North Carolina", "country"=>"United States", "facility"=>"Comprehensive Cancer Center of Wake Forest University Baptist Medical Center", "geoPoint"=>{"lat"=>36.09986, "lon"=>-80.24422}}, {"zip"=>"45219", "city"=>"Cincinnati", "state"=>"Ohio", "country"=>"United States", "facility"=>"Barrett Cancer Center, The University Hospital", "geoPoint"=>{"lat"=>39.12713, "lon"=>-84.51435}}, {"zip"=>"44106-5065", "city"=>"Cleveland", "state"=>"Ohio", "country"=>"United States", "facility"=>"Ireland Cancer Center", "geoPoint"=>{"lat"=>41.4995, "lon"=>-81.69541}}, {"zip"=>"44195", "city"=>"Cleveland", "state"=>"Ohio", "country"=>"United States", "facility"=>"Cleveland Clinic Taussig Cancer Center", "geoPoint"=>{"lat"=>41.4995, "lon"=>-81.69541}}, {"zip"=>"43210", "city"=>"Columbus", "state"=>"Ohio", "country"=>"United States", "facility"=>"Arthur G. 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Rose, MD", "role"=>"STUDY_CHAIR", "affiliation"=>"The Cleveland Clinic"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Gynecologic Oncology Group", "class"=>"NETWORK"}, "collaborators"=>[{"name"=>"National Cancer Institute (NCI)", "class"=>"NIH"}]}}}