The Treatment of Grade I Sarcomas and Benign, Non-Metastasizing Highly Invasive Soft Tissue Tumors

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 9, 2002

Nctid: NCT00001189

Payload: {"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D012509", "term"=>"Sarcoma"}, {"id"=>"D012983", "term"=>"Soft Tissue Neoplasms"}], "ancestors"=>[{"id"=>"D018204", "term"=>"Neoplasms, Connective and Soft Tissue"}, {"id"=>"D009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D009371", "term"=>"Neoplasms by Site"}], "browseLeaves"=>[{"id"=>"M15327", "name"=>"Sarcoma", "asFound"=>"Sarcoma", "relevance"=>"HIGH"}, {"id"=>"M15785", "name"=>"Soft Tissue Neoplasms", "asFound"=>"Soft Tissue Tumors", "relevance"=>"HIGH"}, {"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", "asFound"=>"Sarcoma", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>150}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1983-12"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2000-05", "completionDateStruct"=>{"date"=>"2001-04"}, "lastUpdateSubmitDate"=>"2008-03-03", "studyFirstSubmitDate"=>"1999-11-03", "studyFirstSubmitQcDate"=>"2002-12-09", "lastUpdatePostDateStruct"=>{"date"=>"2008-03-04", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2002-12-10", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Adjuvant Radiotherapy", "Low-Grade Sarcoma", "Radiotherapy", "Randomized Study", "Sarcoma", "Surgery"], "conditions"=>["Sarcoma", "Neoplasms"]}, "referencesModule"=>{"references"=>[{"pmid"=>"405711", "type"=>"BACKGROUND", "citation"=>"Wara WM, Phillips TL, Hill DR, Bovill E Jr, Luk KH, Lichter AS, Leibel SA. Desmoid tumors--treatment and prognosis. Radiology. 1977 Jul;124(1):225-6. doi: 10.1148/124.1.225."}]}, "descriptionModule"=>{"briefSummary"=>"Patients with Grade I soft tissue sarcomas or benign, non-metastasizing invasive soft tissue tumors will receive wide local excision and be prospectively randomized as to either receive or not receive radiation therapy.", "detailedDescription"=>"This is a randomized study. Patients undergo surgical excision of all gross disease and then are randomized to Arm I or Arm II.\n\nArm I: Radiotherapy. Involved-field irradiation.\n\nArm II: No further treatment."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"DISEASE CHARACTERISTICS:\n\nBiopsy-proven grade I soft tissue sarcoma or one of the following benign but highly invasive soft tissue tumors:\n\nAbdominal and extra-abdominal fibromatosis (desmoid,\n\naggressive fibromatosis),\n\nDermatofibrosarcoma protuberans,\n\nIntramuscular lipoma (infiltrating lipoma),\n\nDiffuse lipomatosis,\n\nLeiomyoma of deep soft tissue,\n\nDiffuse giant cell tumor of tendon sheath (proliferative synovitis).\n\nNo clinical evidence of metastases in regional nodes or more distant sites.\n\nNo primary intraperitoneal or retroperitoneal tumors.\n\nResection of all gross tumor at the time of surgical excision required (margins may be pathologically positive or negative).\n\nNo von Recklinghausen's disease.\n\nPRIOR/CONCURRENT THERAPY:\n\nBiologic Therapy: Not specified.\n\nChemotherapy: No prior chemotherapy for sarcoma.\n\nEndocrine Therapy: Not specified.\n\nRadiotherapy: No prior radiotherapy for sarcoma.\n\nSurgery: No more than 4 months since definitive surgery for\n\nprimary lesion or recurrence.\n\nNo prior amputation.\n\nPATIENT CHARACTERISTICS:\n\nAge: 18 and over.\n\nPerformance status: Not specified.\n\nHematopoietic: Not specified.\n\nHepatic: No cirrhosis.\n\nRenal: No evidence of severe renal impairment.\n\nCardiovascular: No ischemic heart disease.\n\nOTHER:\n\nNo prior malignancy except basal cell carcinoma.\n\nNo serious infection.\n\nNo active bleeding disorder.\n\nNo severe concomitant disease."}, "identificationModule"=>{"nctId"=>"NCT00001189", "briefTitle"=>"The Treatment of Grade I Sarcomas and Benign, Non-Metastasizing Highly Invasive Soft Tissue Tumors", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"The Treatment of Grade I Sarcomas and Benign, Non-Metastasizing Highly Invasive Soft Tissue Tumors", "orgStudyIdInfo"=>{"id"=>"830227"}, "secondaryIdInfos"=>[{"id"=>"83-C-0227"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"radiotherapy", "type"=>"PROCEDURE"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"20892", "city"=>"Bethesda", "state"=>"Maryland", "country"=>"United States", "facility"=>"National Cancer Institute (NCI)", "geoPoint"=>{"lat"=>38.98067, "lon"=>-77.10026}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Cancer Institute (NCI)", "class"=>"NIH"}}}}