Nctid:
NCT00002459
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D012509", "term"=>"Sarcoma"}, {"id"=>"D016889", "term"=>"Endometrial Neoplasms"}], "ancestors"=>[{"id"=>"D018204", "term"=>"Neoplasms, Connective and Soft Tissue"}, {"id"=>"D009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D014594", "term"=>"Uterine Neoplasms"}, {"id"=>"D005833", "term"=>"Genital Neoplasms, Female"}, {"id"=>"D014565", "term"=>"Urogenital Neoplasms"}, {"id"=>"D009371", "term"=>"Neoplasms by Site"}, {"id"=>"D014591", "term"=>"Uterine Diseases"}, {"id"=>"D005831", "term"=>"Genital Diseases, Female"}, {"id"=>"D052776", "term"=>"Female Urogenital Diseases"}, {"id"=>"D005261", "term"=>"Female Urogenital Diseases and Pregnancy Complications"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D000091662", "term"=>"Genital Diseases"}], "browseLeaves"=>[{"id"=>"M15327", "name"=>"Sarcoma", "asFound"=>"Sarcoma", "relevance"=>"HIGH"}, {"id"=>"M17342", "name"=>"Uterine Neoplasms", "relevance"=>"LOW"}, {"id"=>"M10902", "name"=>"Leiomyosarcoma", "relevance"=>"LOW"}, {"id"=>"M5552", "name"=>"Carcinosarcoma", "relevance"=>"LOW"}, {"id"=>"M20346", "name"=>"Mixed Tumor, Mullerian", "relevance"=>"LOW"}, {"id"=>"M20349", "name"=>"Sarcoma, Endometrial Stromal", "relevance"=>"LOW"}, {"id"=>"M19235", "name"=>"Endometrial Neoplasms", "asFound"=>"Endometrial Cancer", "relevance"=>"HIGH"}, {"id"=>"M20350", "name"=>"Neoplasms, Connective and Soft Tissue", "relevance"=>"LOW"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M8945", "name"=>"Genital Neoplasms, Female", "relevance"=>"LOW"}, {"id"=>"M17315", "name"=>"Urogenital Neoplasms", "relevance"=>"LOW"}, {"id"=>"M17339", "name"=>"Uterine Diseases", "relevance"=>"LOW"}, {"id"=>"M8943", "name"=>"Genital Diseases, Female", "relevance"=>"LOW"}, {"id"=>"M2876", "name"=>"Genital Diseases", "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"=>"T5284", "name"=>"Soft Tissue Sarcoma", "asFound"=>"Sarcoma", "relevance"=>"HIGH"}, {"id"=>"T3367", "name"=>"Leiomyosarcoma", "relevance"=>"LOW"}, {"id"=>"T3586", "name"=>"Malignant Mixed Mullerian Tumor", "relevance"=>"LOW"}, {"id"=>"T5821", "name"=>"Uterine Sarcoma", "asFound"=>"Uterine sarcoma", "relevance"=>"HIGH"}, {"id"=>"T2073", "name"=>"Endometrial Stromal 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"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>224}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1988-04"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2012-09", "lastUpdateSubmitDate"=>"2012-09-20", "studyFirstSubmitDate"=>"1999-11-01", "studyFirstSubmitQcDate"=>"2004-03-10", "lastUpdatePostDateStruct"=>{"date"=>"2012-09-24", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2004-03-11", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"2001-08", "type"=>"ACTUAL"}}, "conditionsModule"=>{"keywords"=>["stage I uterine sarcoma", "stage II uterine sarcoma", "uterine carcinosarcoma", "uterine leiomyosarcoma", "endometrial stromal sarcoma"], "conditions"=>["Endometrial Cancer", "Sarcoma"]}, "referencesModule"=>{"references"=>[{"pmid"=>"18378136", "type"=>"RESULT", "citation"=>"Reed NS, Mangioni C, Malmstrom H, Scarfone G, Poveda A, Pecorelli S, Tateo S, Franchi M, Jobsen JJ, Coens C, Teodorovic I, Vergote I, Vermorken JB; European Organisation for Research and Treatment of Cancer Gynaecological Cancer Group. Phase III randomised study to evaluate the role of adjuvant pelvic radiotherapy in the treatment of uterine sarcomas stages I and II: an European Organisation for Research and Treatment of Cancer Gynaecological Cancer Group Study (protocol 55874). Eur J Cancer. 2008 Apr;44(6):808-18. doi: 10.1016/j.ejca.2008.01.019. Epub 2008 Apr 2. Erratum In: Eur J Cancer. 2008 Jul;44(11):1612."}, {"type"=>"RESULT", "citation"=>"Reed NS, Mangioni C, Malmstrom H, et al.: First results of a randomised trial comparing radiotherapy versus observation post operatively in patients with uterine sarcomas. An EORTC-GCG study. [Abstract] Int J Gynecol Cancer 13 (Suppl 1): A-PL12, 4, 2003."}]}, "descriptionModule"=>{"briefSummary"=>"RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether receiving radiation therapy or no further therapy after surgery is more effective for cancer of the uterus.\n\nPURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with that of no further therapy in treating patients who have stage I or stage II cancer of the uterus that has been surgically removed.", "detailedDescription"=>"OBJECTIVES: I. Compare the rates of pelvic recurrence and development of distant metastases in patients with completely resected, stage I or II, high-grade uterine sarcoma treated with adjuvant pelvic radiotherapy vs observation alone.\n\nOUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, tumor histology (leiomyosarcoma vs mixed mesodermal sarcoma vs endometrial stromal sarcoma), and surgical procedure (total abdominal hysterectomy (TAH) with or without bilateral salpingo-oophorectomy (BSO) vs TAH and BSO with pelvic and para-aortic node sampling and random biopsies). Patients are randomized to 1 of 2 treatment arms. Arm I: Beginning within 6 weeks after surgery, patients undergo pelvic radiotherapy 5 days a week for 5.6 weeks. Arm II: Patients undergo observation alone. Patients are followed every 2 months for 1 year, every 3 months for 2 years, and then every 6 months thereafter.\n\nPROJECTED ACCRUAL: A total of 200 patients (100 per arm) will be accrued for this study within 3 years."}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"DISEASE CHARACTERISTICS: Histologically proven high-grade uterine sarcoma Eligible subtypes: Leiomyosarcoma Mixed mesodermal (mullerian) sarcoma Endometrial sarcoma Surgically proven stage I or II (T1-2, N0, M0) disease No leiomyoma with a high mitotic activity index after hormonal therapy (especially estrogen) Mixoid leiomyosarcoma with a low mitotic activity index allowed Completely resected disease Prior abdominal hysterectomy as minimal surgical procedure required\n\nPATIENT CHARACTERISTICS: Age: Any age Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix No serious mental disorder\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: See Disease Characteristics Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics"}, "identificationModule"=>{"nctId"=>"NCT00002459", "briefTitle"=>"Radiation Therapy or No Further Treatment Following Surgery in Treating Patients With Cancer of the Uterus", "organization"=>{"class"=>"NETWORK", "fullName"=>"European Organisation for Research and Treatment of Cancer - EORTC"}, "officialTitle"=>"Phase III Randomized Study of Adjuvant Pelvic Radiotherapy Versus Observation Alone in Patients With Completely Resected, Stage I or II, High-Grade Uterine Sarcoma", "orgStudyIdInfo"=>{"id"=>"EORTC-55874"}, "secondaryIdInfos"=>[{"id"=>"EORTC-55874"}, {"id"=>"CAN-NCIC-EN4"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"radiation therapy", "type"=>"RADIATION"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"B-3000", "city"=>"Leuven", "country"=>"Belgium", "facility"=>"U.Z. Gasthuisberg", "geoPoint"=>{"lat"=>50.87959, "lon"=>4.70093}}, {"zip"=>"T2N 4N2", "city"=>"Calgary", "state"=>"Alberta", "country"=>"Canada", "facility"=>"Tom Baker Cancer Center - Calgary", "geoPoint"=>{"lat"=>51.05011, "lon"=>-114.08529}}, {"zip"=>"J1H 5N4", "city"=>"Fleurimont", "state"=>"Quebec", "country"=>"Canada", "facility"=>"CHUS-Hopital Fleurimont", "geoPoint"=>{"lat"=>45.41455, "lon"=>-71.84873}}, {"zip"=>"76038", "city"=>"Rouen", "country"=>"France", "facility"=>"Centre Henri Becquerel", "geoPoint"=>{"lat"=>49.44313, "lon"=>1.09932}}, {"zip"=>"25124", "city"=>"Brescia", "country"=>"Italy", "facility"=>"Spedali Civili", "geoPoint"=>{"lat"=>45.53558, "lon"=>10.21472}}, {"zip"=>"20132", "city"=>"Milano", "country"=>"Italy", "facility"=>"Istituto Scientifico H.S. Raffaele", "geoPoint"=>{"lat"=>45.46427, "lon"=>9.18951}}, {"zip"=>"20133", "city"=>"Milan", "country"=>"Italy", "facility"=>"Istituto Nazionale per lo Studio e la Cura dei Tumori", "geoPoint"=>{"lat"=>45.46427, "lon"=>9.18951}}, {"zip"=>"20052", "city"=>"Monza", "country"=>"Italy", "facility"=>"Ospedale San Gerardo", "geoPoint"=>{"lat"=>45.58005, "lon"=>9.27246}}, {"zip"=>"35128", "city"=>"Padova", "country"=>"Italy", "facility"=>"Universita di Padova", "geoPoint"=>{"lat"=>45.40797, "lon"=>11.88586}}, {"zip"=>"27100", "city"=>"Pavia", "country"=>"Italy", "facility"=>"I.R.C.C.S. Policlinico San Matteo", "geoPoint"=>{"lat"=>45.19205, "lon"=>9.15917}}, {"zip"=>"21100", "city"=>"Varese", "country"=>"Italy", "facility"=>"Ospedale di Circolo e Fondazione Macchi", "geoPoint"=>{"lat"=>45.82058, "lon"=>8.82511}}, {"zip"=>"27058", "city"=>"Voghera (PV)", "country"=>"Italy", "facility"=>"Ospedale Civile"}, {"zip"=>"1001HV", "city"=>"Amsterdam", "country"=>"Netherlands", "facility"=>"Vrije Universiteit Medisch Centrum", "geoPoint"=>{"lat"=>52.37403, "lon"=>4.88969}}, {"zip"=>"1066 CX", "city"=>"Amsterdam", "country"=>"Netherlands", "facility"=>"Antoni van Leeuwenhoekhuis", "geoPoint"=>{"lat"=>52.37403, "lon"=>4.88969}}, {"zip"=>"7500 KA", "city"=>"Enschede", "country"=>"Netherlands", "facility"=>"Medisch Spectrum Twente", "geoPoint"=>{"lat"=>52.21833, "lon"=>6.89583}}, {"zip"=>"6419 PC", "city"=>"Heerlen", "country"=>"Netherlands", "facility"=>"Atrium Medical Centre", "geoPoint"=>{"lat"=>50.88365, "lon"=>5.98154}}, {"zip"=>"6202 AZ", "city"=>"Maastricht", "country"=>"Netherlands", "facility"=>"Academisch Ziekenhuis Maastricht", "geoPoint"=>{"lat"=>50.84833, "lon"=>5.68889}}, {"zip"=>"NL-6252 HB", "city"=>"Nijmegen", "country"=>"Netherlands", "facility"=>"University Medical Center Nijmegen", "geoPoint"=>{"lat"=>51.8425, "lon"=>5.85278}}, {"zip"=>"3000 CA", "city"=>"Rotterdam", "country"=>"Netherlands", "facility"=>"University Hospital - Rotterdam Dijkzigt", "geoPoint"=>{"lat"=>51.9225, "lon"=>4.47917}}, {"zip"=>"3075 EA", "city"=>"Rotterdam", "country"=>"Netherlands", "facility"=>"Rotterdam Cancer Institute", "geoPoint"=>{"lat"=>51.9225, "lon"=>4.47917}}, {"zip"=>"3508 GA", "city"=>"Utrecht", "country"=>"Netherlands", "facility"=>"Academisch Ziekenhuis Utrecht", "geoPoint"=>{"lat"=>52.09083, "lon"=>5.12222}}, {"zip"=>"80-211", "city"=>"Gdansk", "country"=>"Poland", "facility"=>"Medical University of Gdansk", "geoPoint"=>{"lat"=>54.35205, "lon"=>18.64637}}, {"zip"=>"46009", "city"=>"Valencia", "country"=>"Spain", "facility"=>"Instituto Valenciano De Oncologia", "geoPoint"=>{"lat"=>39.46975, "lon"=>-0.37739}}, {"zip"=>"S-581 85", "city"=>"Linkoping", "country"=>"Sweden", "facility"=>"University Hospital of Linkoping", "geoPoint"=>{"lat"=>58.41086, "lon"=>15.62157}}, {"zip"=>"S-171 76", "city"=>"Stockholm", "country"=>"Sweden", "facility"=>"Karolinska Hospital", "geoPoint"=>{"lat"=>59.33258, "lon"=>18.0649}}, {"zip"=>"CH-1211", "city"=>"Geneva", "country"=>"Switzerland", "facility"=>"Hopital Cantonal Universitaire de Geneva", "geoPoint"=>{"lat"=>46.20222, "lon"=>6.14569}}, {"zip"=>"DE1 2QY", "city"=>"Derby", "state"=>"England", "country"=>"United Kingdom", "facility"=>"Derbyshire Royal Infirmary", "geoPoint"=>{"lat"=>52.92277, "lon"=>-1.47663}}, {"zip"=>"G11 6NT", "city"=>"Glasgow", "state"=>"Scotland", "country"=>"United Kingdom", "facility"=>"Beatson Oncology Centre", "geoPoint"=>{"lat"=>55.86515, "lon"=>-4.25763}}], "overallOfficials"=>[{"name"=>"Sergio L. Pecorelli, MD", "role"=>"STUDY_CHAIR", "affiliation"=>"Spedali Civili di Brescia"}, {"name"=>"Gavin C.E. Stuart, MD", "role"=>"STUDY_CHAIR", "affiliation"=>"Tom Baker Cancer Centre - Calgary"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"European Organisation for Research and Treatment of Cancer - EORTC", "class"=>"NETWORK"}, "collaborators"=>[{"name"=>"NCIC Clinical Trials Group", "class"=>"NETWORK"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
