The Role of Multi-Modality Therapy for the Treatment of High-Grade Soft Tissue Sarcomas of the Extremities

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

Nctid: NCT00001188

Payload: {"FullStudy"=>{"Rank"=>491637, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"April 26, 2024"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000012509", "ConditionMeshTerm"=>"Sarcoma"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000018204", "ConditionAncestorTerm"=>"Neoplasms, Connective and Soft Tissue"}, {"ConditionAncestorId"=>"D000009370", "ConditionAncestorTerm"=>"Neoplasms by Histologic Type"}, {"ConditionAncestorId"=>"D000009369", "ConditionAncestorTerm"=>"Neoplasms"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M15327", "ConditionBrowseLeafName"=>"Sarcoma", "ConditionBrowseLeafAsFound"=>"Sarcoma", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M20350", "ConditionBrowseLeafName"=>"Neoplasms, Connective and Soft Tissue", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12315", "ConditionBrowseLeafName"=>"Neoplasms by Histologic Type", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T5284", "ConditionBrowseLeafName"=>"Soft Tissue Sarcoma", "ConditionBrowseLeafAsFound"=>"Soft Tissue Sarcoma", "ConditionBrowseLeafRelevance"=>"high"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Neoplasms", "ConditionBrowseBranchAbbrev"=>"BC04"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Rare Diseases", "ConditionBrowseBranchAbbrev"=>"Rare"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 2"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"100"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"December 1983"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"November 1999", "CompletionDateStruct"=>{"CompletionDate"=>"September 2000"}, "LastUpdateSubmitDate"=>"March 3, 2008", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"December 9, 2002", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"March 4, 2008", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"December 10, 2002", "StudyFirstPostDateType"=>"Estimate"}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Chemotherapy", "Radiation Therapy", "Sarcoma", "Surgery"]}, "ConditionList"=>{"Condition"=>["Sarcoma"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"1122498", "ReferenceType"=>"background", "ReferenceCitation"=>"Suit HD, Russell WO, Martin RG. Sarcoma of soft tissue: clinical and histopathologic parameters and response to treatment. Cancer. 1975 May;35(5):1478-83. doi: 10.1002/1097-0142(197505)35:53.0.co;2-1."}, {"ReferencePMID"=>"7272893", "ReferenceType"=>"background", "ReferenceCitation"=>"Lindberg RD, Martin RG, Romsdahl MM, Barkley HT Jr. Conservative surgery and postoperative radiotherapy in 300 adults with soft-tissue sarcomas. Cancer. 1981 May 15;47(10):2391-7. doi: 10.1002/1097-0142(19810515)47:103.0.co;2-b."}, {"ReferencePMID"=>"4298242", "ReferenceType"=>"background", "ReferenceCitation"=>"McNeer GP, Cantin J, Chu F, Nickson JJ. Effectiveness of radiation therapy in the management of sarcoma of the soft somatic tissues. Cancer. 1968 Aug;22(2):391-7. doi: 10.1002/1097-0142(196808)22:23.0.co;2-q. No abstract available."}]}}, "DescriptionModule"=>{"BriefSummary"=>"Patients with Grade II and III soft tissue sarcomas of the extremity will be randomized to either receive or not receive radiation therapy following surgery for the removal of the local tumor. All patients in this protocol will receive adjuvant chemotherapy.", "DetailedDescription"=>"Patients with Grade II and III soft tissue sarcomas of the extremity will be randomized to either receive or not receive radiation therapy following surgery for the removal of the local tumor. All patients in this protocol will receive adjuvant chemotherapy."}, "EligibilityModule"=>{"Gender"=>"All", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Patients must have biopsy-proven soft tissue sarcoma with one of the following diagnoses:\n\nLiposarcoma (round cell or pleomorphic).\n\nFibrosarcoma.\n\nMalignant fibrous histiocytoma.\n\nInflammatory malignant fibrous histiocytoma.\n\nMyxoid malignant fibrous histiocytoma.\n\nMalignant giant cell tumor.\n\nAngiomatoid malignant fibrous histiocytoma.\n\nLeiomyosarcoma.\n\nMalignant hemangiopericytoma.\n\nRhabdomyosarcoma (embryonal, alveolar, pleomorphic or combined).\n\nSoft tissue sarcoma resembling Ewing's sarcoma.\n\nSynovial cell sarcoma.\n\nEpithelioid sarcoma.\n\nClear cell sarcoma.\n\nNeurofibrosarcoma.\n\nEpithelioid schwannoma.\n\nMalignant triton tumor.\n\nAngiosarcoma.\n\nMixed malignant mesenchymoma.\n\nAlvelar soft part sarcoma.\n\nMalignant granular cell tumor.\n\nAll lesions must be Grade II or III. No patients with Grade I lesions will be acceptable.\n\nPatients must have undergone a limb-sparing procedure in which all gross tumor has been removed.\n\nClinical evaluation must reveal no evidence of metastatic disease either in regional lymph nodes or more distant sites.\n\nThe soft tissue sarcoma must be on the extremity either at or distal to the shoulder joint or at or distal to the hip joint.\n\nThe definitive surgical procedure for a primary lesion or for a recurrence must have been performed no longer than four months from the date of randomization.\n\nPatients must not have received any prior chemotherapy or radiotherapy for their sarcoma.\n\nPatients without a history of any other malignant disease except basal cell carcinoma.\n\nPatients who have not had a serious infection, active bleeding disorders, or concomitant severe disease such as cirrhosis, ischemic heart disease, or evidence of severe impairment of renal function.\n\nPatients must be above the age of 30 and do not have a diagnosis of embryonal rhabdomyosarcoma."}, "IdentificationModule"=>{"NCTId"=>"NCT00001188", "BriefTitle"=>"The Role of Multi-Modality Therapy for the Treatment of High-Grade Soft Tissue Sarcomas of the Extremities", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"The Role of Multi-Modality Therapy for the Treatment of High-Grade Soft Tissue Sarcomas of the Extremities", "OrgStudyIdInfo"=>{"OrgStudyId"=>"830212"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"83-C-0212"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"radiation therapy following surgery", "InterventionType"=>"Procedure"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"20892", "LocationCity"=>"Bethesda", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"National Cancer Institute (NCI)"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Cancer Institute (NCI)", "LeadSponsorClass"=>"NIH"}}}}}}