Nctid:
NCT00002492
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-05"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D012509", "term"=>"Sarcoma"}], "ancestors"=>[{"id"=>"D018204", "term"=>"Neoplasms, Connective and Soft Tissue"}, {"id"=>"D009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D009369", "term"=>"Neoplasms"}], "browseLeaves"=>[{"id"=>"M15327", "name"=>"Sarcoma", "asFound"=>"Sarcoma", "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"=>"Soft Tissue Sarcoma", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D004317", "term"=>"Doxorubicin"}, {"id"=>"C506643", "term"=>"Liposomal doxorubicin"}], "ancestors"=>[{"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D000903", "term"=>"Antibiotics, Antineoplastic"}, {"id"=>"D059005", "term"=>"Topoisomerase II Inhibitors"}, {"id"=>"D059003", "term"=>"Topoisomerase Inhibitors"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}], "browseLeaves"=>[{"id"=>"M6182", "name"=>"Cisplatin", "relevance"=>"LOW"}, {"id"=>"M7492", "name"=>"Doxorubicin", "asFound"=>"Extension", "relevance"=>"HIGH"}, {"id"=>"M227339", "name"=>"Liposomal doxorubicin", "asFound"=>"Extension", "relevance"=>"HIGH"}, {"id"=>"M4222", "name"=>"Anti-Bacterial Agents", "relevance"=>"LOW"}, {"id"=>"M4224", "name"=>"Antibiotics, Antitubercular", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1991-11"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2016-12", "completionDateStruct"=>{"date"=>"2000-02", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2016-12-14", "studyFirstSubmitDate"=>"1999-11-01", "studyFirstSubmitQcDate"=>"2004-04-21", "lastUpdatePostDateStruct"=>{"date"=>"2016-12-15", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2004-04-22", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"2000-02", "type"=>"ACTUAL"}}, "conditionsModule"=>{"keywords"=>["stage I adult soft tissue sarcoma", "stage II adult soft tissue sarcoma", "stage III adult soft tissue sarcoma"], "conditions"=>["Sarcoma"]}, "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 may kill more tumor cells.\n\nPURPOSE: Phase II trial to study the effectiveness of combining cisplatin and doxorubicin in treating patients who have soft tissue sarcoma.", "detailedDescription"=>"OBJECTIVES: I. Determine the response in patients with resectable soft tissue sarcoma of the extremity treated with neoadjuvant intra-arterial cisplatin and IV doxorubicin followed by limb-sparing procedure or amputation, adjuvant IV cisplatin and IV doxorubicin, and radiotherapy. II. Determine the chemotherapeutic response in tumor specimens of patients treated with this regimen.\n\nOUTLINE: Neoadjuvant chemotherapy: Patients undergo arterial cannulation followed by cisplatin intra-arterially over 4 hours on day 1 and doxorubicin IV (beginning 15 minutes after completion of cisplatin infusion) on days 1-3. Treatment continues every 3 weeks for 2 courses in the absence of unacceptable toxicity. Patients undergo amputation or limb-sparing wide excision, as feasible, approximately 4 weeks after the second course. If surgery cannot be scheduled at this time for logistical reasons, a third course may be administered. Patients with an estimated tumor kill of at least 50% receive adjuvant chemotherapy as outlined below. Patients undergoing limb-sparing wide excision receive post-operative radiotherapy as outlined below. Adjuvant chemotherapy: Beginning 3-4 weeks after surgery, patients receive cisplatin IV over 4 hours on day 1 and doxorubicin as above on days 1-3. Treatment continues every 3 weeks for 4 courses in the absence of disease progression, stable disease, or unacceptable toxicity. Patients undergoing radiotherapy receive the final 3 courses of chemotherapy after completion of radiotherapy. Post-operative radiotherapy: Beginning after the first postoperative chemotherapy course and within 8 weeks after surgery, patients receive radiotherapy 5 days a week for 7-8 weeks. An interstitial implant using iridium Ir 192 may be used to administer the final doses of radiotherapy.\n\nPROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4 years."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"120 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"DISEASE CHARACTERISTICS: Diagnosis of intermediate- or high-grade soft tissue sarcoma of the extremity amenable to limb-sparing procedure or amputation Buttocks or shoulder lesions allowed if an artery is available for cannulation No metastasis\n\nPATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL Renal: Creatinine clearance at least 60 mL/min Cardiovascular: Ejection fraction at least 50% by MUGA scan No history of congestive heart failure or severe angina pectoris Other: No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix Not pregnant Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics"}, "identificationModule"=>{"nctId"=>"NCT00002492", "briefTitle"=>"Combination Chemotherapy in Treating Patients With Soft Tissue Sarcoma", "organization"=>{"class"=>"OTHER", "fullName"=>"University of Miami"}, "officialTitle"=>"CLINICAL AND PHARMACOLOGICAL STUDY OF CHEMOTHERAPY IN SOFT TISSUE SARCOMA", "orgStudyIdInfo"=>{"id"=>"89253"}, "secondaryIdInfos"=>[{"id"=>"SCCC-1989032", "type"=>"OTHER", "domain"=>"University of Miami Sylvester Comprehensive Cancer Center"}, {"id"=>"NCI-V92-0066"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"cisplatin", "type"=>"DRUG"}, {"name"=>"doxorubicin hydrochloride", "type"=>"DRUG"}, {"name"=>"isolated limb perfusion", "type"=>"DRUG"}, {"name"=>"conventional surgery", "type"=>"PROCEDURE"}, {"name"=>"brachytherapy", "type"=>"RADIATION"}, {"name"=>"radiation therapy", "type"=>"RADIATION"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"33136", "city"=>"Miami", "state"=>"Florida", "country"=>"United States", "facility"=>"Sylvester Cancer Center, University of Miami", "geoPoint"=>{"lat"=>25.77427, "lon"=>-80.19366}}], "overallOfficials"=>[{"name"=>"Pasquale W. Benedetto, MD", "role"=>"STUDY_CHAIR", "affiliation"=>"University of Miami Sylvester Comprehensive Cancer Center"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University of Miami", "class"=>"OTHER"}}}}
