Nctid:
NCT00002546
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D012509", "term"=>"Sarcoma"}, {"id"=>"D002296", "term"=>"Carcinosarcoma"}], "ancestors"=>[{"id"=>"D018204", "term"=>"Neoplasms, Connective and Soft Tissue"}, {"id"=>"D009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D018193", "term"=>"Neoplasms, Complex and Mixed"}], "browseLeaves"=>[{"id"=>"M15327", "name"=>"Sarcoma", "asFound"=>"Sarcoma", "relevance"=>"HIGH"}, {"id"=>"M17342", "name"=>"Uterine Neoplasms", "relevance"=>"LOW"}, {"id"=>"M5552", "name"=>"Carcinosarcoma", "asFound"=>"Carcinosarcoma", "relevance"=>"HIGH"}, {"id"=>"M20346", "name"=>"Mixed Tumor, Mullerian", "relevance"=>"LOW"}, {"id"=>"M20350", "name"=>"Neoplasms, Connective and Soft Tissue", "relevance"=>"LOW"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"T5284", "name"=>"Soft Tissue Sarcoma", "relevance"=>"LOW"}, {"id"=>"T3586", "name"=>"Malignant Mixed Mullerian Tumor", "relevance"=>"LOW"}, {"id"=>"T5821", "name"=>"Uterine Sarcoma", "relevance"=>"LOW"}, {"id"=>"T5820", "name"=>"Uterine Carcinosarcoma", "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"=>"D007069", "term"=>"Ifosfamide"}], "ancestors"=>[{"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D018906", "term"=>"Antineoplastic Agents, Alkylating"}, {"id"=>"D000477", "term"=>"Alkylating Agents"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}], "browseLeaves"=>[{"id"=>"M6182", "name"=>"Cisplatin", "relevance"=>"LOW"}, {"id"=>"M10117", "name"=>"Ifosfamide", "asFound"=>"Steroid", "relevance"=>"HIGH"}, {"id"=>"M230811", "name"=>"Isophosphamide mustard", "relevance"=>"LOW"}, {"id"=>"M17811", "name"=>"Mesna", "relevance"=>"LOW"}, {"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"=>216}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1993-12"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2016-02", "lastUpdateSubmitDate"=>"2016-02-10", "studyFirstSubmitDate"=>"1999-11-01", "studyFirstSubmitQcDate"=>"2003-01-26", "lastUpdatePostDateStruct"=>{"date"=>"2016-02-11", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2003-01-27", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"2007-09", "type"=>"ACTUAL"}}, "conditionsModule"=>{"keywords"=>["stage I uterine sarcoma", "stage II uterine sarcoma", "stage III uterine sarcoma", "stage IV uterine sarcoma", "uterine carcinosarcoma"], "conditions"=>["Sarcoma"]}, "referencesModule"=>{"references"=>[{"pmid"=>"17822748", "type"=>"RESULT", "citation"=>"Wolfson AH, Brady MF, Rocereto T, Mannel RS, Lee YC, Futoran RJ, Cohn DE, Ioffe OB. A gynecologic oncology group randomized phase III trial of whole abdominal irradiation (WAI) vs. cisplatin-ifosfamide and mesna (CIM) as post-surgical therapy in stage I-IV carcinosarcoma (CS) of the uterus. Gynecol Oncol. 2007 Nov;107(2):177-85. doi: 10.1016/j.ygyno.2007.07.070. Epub 2007 Sep 5."}]}, "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. It is not yet known whether radiation therapy is more effective than combination chemotherapy in treating patients with cancer of the uterus.\n\nPURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to combination chemotherapy in treating patients with cancer of the uterus.", "detailedDescription"=>"OBJECTIVES:\n\n* Compare the survival, progression-free interval, and failure patterns in patients with optimally debulked stage I-IV carcinosarcoma of the uterus treated with whole abdominal radiotherapy vs ifosfamide and cisplatin.\n* Compare the incidence and type of acute and late adverse events observed with these treatment regimens in this patient population.\n\nOUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.\n\n* Arm I: Patients receive whole abdominal radiotherapy 5 days a week for 4 weeks, followed by radiotherapy boost to the pelvis 5 days a week for 2.2 weeks.\n* Arm II: Patients receive cisplatin IV followed by ifosfamide IV over 1 hour on days 1-4. Treatment continues every 3 weeks for 3 courses.\n\nPatients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.\n\nPROJECTED ACCRUAL: A total of 216 patients will be accrued for this study within 6 years."}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"120 years", "minimumAge"=>"21 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"DISEASE CHARACTERISTICS:\n\n* Histologically confirmed primary homologous or heterologous carcinosarcoma of the uterus (corpus and cervix)\n* Surgical stage I-IV disease, including positive adnexa, tumor invading the serosa, positive pelvic and/or para-aortic nodes, involvement of the mucosa of the bowel, bladder, or rectum, intra-abdominal metastases, positive pelvic washings, or vaginal involvement within planned radiation port\n* Prior total abdominal hysterectomy with bilateral salpingo-oophorectomy and maximum tumor resection of all gross intra-abdominal/pelvic disease, including grossly involved pelvic and para-aortic nodes within 8 weeks before study\n\n * No greater than 1 cm residual disease\n* Cervical sarcomas also allowed\n* No metastasis beyond the abdominal cavity at diagnosis, including the following:\n\n * Parenchymal liver metastasis\n * Lung metastasis\n * Positive inguinal lymph nodes\n * Positive scalene nodes\n * Radiographic or pathologic evidence of bone or brain metastasis\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 21 and over\n\nPerformance status:\n\n* GOG 0-2\n\nHematopoietic:\n\n* WBC at least 3,000/mm3\n* Granulocyte count at least 1,500/mm3\n* Platelet count at least 100,000/mm3\n\nHepatic:\n\n* Bilirubin no greater than 1.5 times normal\n* SGOT no greater than 3 times normal\n* Albumin at least 3 g/dL\n* No acute hepatitis\n\nRenal:\n\n* Creatinine no greater than 1.5 mg/dL OR\n* Creatinine clearance at least 50 mL/min\n\nOther:\n\n* No septicemia\n* No severe infection\n* No severe gastrointestinal bleeding\n* No prior invasive or concurrent malignancy within the past 5 years except nonmelanoma skin cancer\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* No prior chemotherapy\n\nEndocrine therapy:\n\n* Prior hormonal therapy allowed\n\nRadiotherapy:\n\n* See Disease Characteristics\n* No prior radiotherapy\n\nSurgery:\n\n* See Disease Characteristics\n\nOther:\n\n* No prior therapy that would preclude study therapy"}, "identificationModule"=>{"nctId"=>"NCT00002546", "briefTitle"=>"Radiation Therapy Compared With Combination Chemotherapy in Treating Patients With Cancer of the Uterus", "organization"=>{"class"=>"NETWORK", "fullName"=>"GOG Foundation"}, "officialTitle"=>"A Phase III Randomized Study of Accelerated Hyperfractionated Whole Abdominal Radiotherapy (AHWAR) Versus Combination Ifosfamide-Mesna With Cisplatin in Optimally Debulked Stage I, II, III, or IV Carcinosarcoma (CS) of The Uterus", "orgStudyIdInfo"=>{"id"=>"GOG-0150"}, "secondaryIdInfos"=>[{"id"=>"CDR0000063303", "type"=>"OTHER", "domain"=>"NIH"}, {"id"=>"ECOG-G150"}, {"id"=>"NCI-2012-02226", "type"=>"OTHER", "domain"=>"NCI"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"cisplatin", "type"=>"DRUG"}, {"name"=>"ifosfamide", "type"=>"DRUG"}, {"name"=>"adjuvant therapy", "type"=>"PROCEDURE"}, {"name"=>"radiation therapy", "type"=>"RADIATION"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"35294-3300", "city"=>"Birmingham", "state"=>"Alabama", "country"=>"United States", "facility"=>"University of Alabama at Birmingham Comprehensive Cancer Center", "geoPoint"=>{"lat"=>33.52066, "lon"=>-86.80249}}, {"zip"=>"85006-2726", "city"=>"Phoenix", "state"=>"Arizona", "country"=>"United States", "facility"=>"CCOP - Western Regional, Arizona", "geoPoint"=>{"lat"=>33.44838, "lon"=>-112.07404}}, {"zip"=>"95032", "city"=>"Los Gatos", "state"=>"California", "country"=>"United States", "facility"=>"Women's Cancer Center - Los Gatos", "geoPoint"=>{"lat"=>37.22661, "lon"=>-121.97468}}, {"zip"=>"92868", "city"=>"Orange", "state"=>"California", "country"=>"United States", "facility"=>"Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center", "geoPoint"=>{"lat"=>33.78779, "lon"=>-117.85311}}, {"zip"=>"80010", "city"=>"Denver", "state"=>"Colorado", "country"=>"United States", "facility"=>"University of Colorado Cancer Center at University of Colorado Health Sciences Center", "geoPoint"=>{"lat"=>39.73915, "lon"=>-104.9847}}, {"zip"=>"19713", "city"=>"Newark", "state"=>"Delaware", "country"=>"United States", "facility"=>"CCOP - Christiana Care Health Services", "geoPoint"=>{"lat"=>39.68372, "lon"=>-75.74966}}, {"zip"=>"20307-5001", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"Walter Reed Army Medical Center", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"33136", "city"=>"Miami", "state"=>"Florida", "country"=>"United States", "facility"=>"University of Miami Sylvester Comprehensive Cancer Center", "geoPoint"=>{"lat"=>25.77427, "lon"=>-80.19366}}, {"zip"=>"60612-3824", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Rush University Medical Center", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"60612", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"MBCCOP - University of Illinois at Chicago", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"60637-1470", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"University of Chicago Cancer Research Center", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"62794-9640", "city"=>"Decatur", "state"=>"Illinois", "country"=>"United States", "facility"=>"CCOP - Central Illinois", "geoPoint"=>{"lat"=>39.84031, "lon"=>-88.9548}}, {"zip"=>"60201", "city"=>"Evanston", "state"=>"Illinois", "country"=>"United States", "facility"=>"CCOP - Evanston", "geoPoint"=>{"lat"=>42.04114, "lon"=>-87.69006}}, {"zip"=>"60521", "city"=>"Hinsdale", "state"=>"Illinois", "country"=>"United States", "geoPoint"=>{"lat"=>41.80086, "lon"=>-87.93701}}, {"zip"=>"61801", "city"=>"Urbana", "state"=>"Illinois", "country"=>"United States", "facility"=>"CCOP - Carle Cancer Center", "geoPoint"=>{"lat"=>40.11059, "lon"=>-88.20727}}, {"zip"=>"46202-5289", "city"=>"Indianapolis", "state"=>"Indiana", "country"=>"United States", "facility"=>"Indiana University Cancer Center", "geoPoint"=>{"lat"=>39.76838, "lon"=>-86.15804}}, {"zip"=>"46601", "city"=>"South Bend", "state"=>"Indiana", "country"=>"United States", "facility"=>"CCOP - 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Wolfson, MD", "role"=>"STUDY_CHAIR", "affiliation"=>"University of Miami Sylvester Comprehensive Cancer Center"}, {"name"=>"Higinia R. Cardenes, MD, PhD", "role"=>"STUDY_CHAIR", "affiliation"=>"Indiana University Melvin and Bren Simon Cancer Center"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Gynecologic Oncology Group", "class"=>"NETWORK"}, "collaborators"=>[{"name"=>"National Cancer Institute (NCI)", "class"=>"NIH"}, {"name"=>"Eastern Cooperative Oncology Group", "class"=>"NETWORK"}]}}}
