Nctid:
NCT00002804
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-27"}, "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"=>"D003035", "term"=>"Cobalt"}, {"id"=>"D004317", "term"=>"Doxorubicin"}, {"id"=>"C506643", "term"=>"Liposomal doxorubicin"}, {"id"=>"D014750", "term"=>"Vincristine"}, {"id"=>"D007069", "term"=>"Ifosfamide"}, {"id"=>"D000078224", "term"=>"Lenograstim"}, {"id"=>"D015080", "term"=>"Mesna"}], "ancestors"=>[{"id"=>"D000903", "term"=>"Antibiotics, Antineoplastic"}, {"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D059005", "term"=>"Topoisomerase II Inhibitors"}, {"id"=>"D059003", "term"=>"Topoisomerase Inhibitors"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000276", "term"=>"Adjuvants, Immunologic"}, {"id"=>"D007155", "term"=>"Immunologic Factors"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000972", "term"=>"Antineoplastic Agents, Phytogenic"}, {"id"=>"D050257", "term"=>"Tubulin Modulators"}, {"id"=>"D050256", "term"=>"Antimitotic Agents"}, {"id"=>"D050258", "term"=>"Mitosis Modulators"}, {"id"=>"D018906", "term"=>"Antineoplastic Agents, Alkylating"}, {"id"=>"D000477", "term"=>"Alkylating Agents"}, {"id"=>"D020011", "term"=>"Protective Agents"}, {"id"=>"D014131", "term"=>"Trace Elements"}, {"id"=>"D018977", "term"=>"Micronutrients"}], "browseLeaves"=>[{"id"=>"M7492", "name"=>"Doxorubicin", "asFound"=>"Arterial", "relevance"=>"HIGH"}, {"id"=>"M227339", "name"=>"Liposomal doxorubicin", "asFound"=>"Arterial", "relevance"=>"HIGH"}, {"id"=>"M17495", "name"=>"Vincristine", "asFound"=>"2 days", "relevance"=>"HIGH"}, {"id"=>"M1945", "name"=>"Lenograstim", "asFound"=>"Cortex", "relevance"=>"HIGH"}, {"id"=>"M6265", "name"=>"Cobalt", "asFound"=>"Atomoxetine", "relevance"=>"HIGH"}, {"id"=>"M10117", "name"=>"Ifosfamide", "asFound"=>"Route", "relevance"=>"HIGH"}, {"id"=>"M230811", "name"=>"Isophosphamide mustard", "relevance"=>"LOW"}, {"id"=>"M17811", "name"=>"Mesna", "asFound"=>"Cancer, Fallopian Tube", "relevance"=>"HIGH"}, {"id"=>"M4222", "name"=>"Anti-Bacterial Agents", "relevance"=>"LOW"}, {"id"=>"M4224", "name"=>"Antibiotics, Antitubercular", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M3628", "name"=>"Adjuvants, Immunologic", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}, {"id"=>"M26197", "name"=>"Tubulin Modulators", "relevance"=>"LOW"}, {"id"=>"M26196", "name"=>"Antimitotic Agents", "relevance"=>"LOW"}, {"id"=>"M20942", "name"=>"Antineoplastic Agents, Alkylating", "relevance"=>"LOW"}, {"id"=>"M3820", "name"=>"Alkylating Agents", "relevance"=>"LOW"}, {"id"=>"M21869", "name"=>"Protective Agents", "relevance"=>"LOW"}, {"id"=>"M21009", "name"=>"Micronutrients", "relevance"=>"LOW"}, {"id"=>"M16885", "name"=>"Trace Elements", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Micronutrients", "abbrev"=>"Micro"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>43}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1996-09"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2014-07", "completionDateStruct"=>{"date"=>"2006-04", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2014-07-24", "studyFirstSubmitDate"=>"1999-11-01", "studyFirstSubmitQcDate"=>"2004-06-30", "lastUpdatePostDateStruct"=>{"date"=>"2014-07-25", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2004-07-01", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"2000-06", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Estimate the response rate to the combination of vincristine, ifosfamide, and doxorubicin (VID), with G-CSF support", "description"=>"To estimate the response rate to the combination of vincristine, ifosfamide, and doxorubicin (VID), with G-CSF support, in children with newly diagnosed inoperable or metastatic non-rhabdomyosarcoma soft tissue sarcomas."}], "secondaryOutcomes"=>[{"measure"=>"Event-free Survival", "description"=>"To estimate the 2-year survival and event-free survival of children treated with VID in combination with radiotherapy and/or surgery"}, {"measure"=>"Establish a bank of frozen tissue (tumor and peripheral blood)", "description"=>"To establish a bank of frozen tissue (tumor and peripheral blood) for use in further molecular studies."}]}, "oversightModule"=>{"oversightHasDmc"=>true}, "conditionsModule"=>{"keywords"=>["nonmetastatic childhood soft tissue sarcoma", "metastatic childhood 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. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.\n\nPURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, surgery, and radiation therapy in treating children who have advanced soft tissue sarcoma.", "detailedDescription"=>"OBJECTIVES: I. Assess the response to vincristine/ifosfamide/doxorubicin (VID) with granulocyte colony-stimulating factor support in children with newly diagnosed, inoperable or metastatic non-rhabdomyosarcoma soft tissue sarcomas. II. Estimate the 2-year and event-free survival rates in children treated with VID plus radiotherapy and/or surgery. III. Establish a bank of frozen tumor and peripheral blood tissue for use in further molecular studies.\n\nOUTLINE: The following acronyms are used: DOX Doxorubicin, NSC-123127 G-CSF Granulocyte Colony-Stimulating Factor (Amgen), NSC-614629 IFF Ifosfamide, NSC-109724 Mesna Mercaptoethane sulfonate, NSC-113891 VCR Vincristine, NSC-67574 VID VCR/IFF/DOX Induction: 3-Drug Combination Chemotherapy. VID. Local Control: Surgery and/or Radiotherapy plus 3-Drug Combination Chemotherapy. Excision of the primary tumor and pulmonary metastases; and/or irradiation of the primary tumor and pulmonary metastases using x-rays or Co60 beam energies of at least 4 MV (electrons or iridium-192 implant allowed for boost); plus VID. Continuation: 3-Drug Combination Chemotherapy. VID.\n\nPROJECTED ACCRUAL: A total of 40 patients will be entered over 2.7 years if there are at least 7 responses in the first 20 patients."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT"], "maximumAge"=>"21 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"DISEASE CHARACTERISTICS: Biopsy proven non-rhabdomyosarcoma soft tissue sarcoma (NRSTS) Evaluable residual tumor after initial biopsy or excision required Registration required within 42 days of definitive diagnosis Grade II/III, unresectable or metastatic disease The following histologies exclude: Angiofibroma of the nasopharynx Mesothelioma Desmoid tumor Peripheral neuroepithelioma Desmoplastic small cell tumor Rhabdomyosarcoma Extraosseous Ewing's sarcoma Undifferentiated sarcoma Kaposi's sarcoma Grade 1 NRSTS, including: Angiomatoid malignant fibrous histiocytoma Dermatofibrosarcoma protuberans Myxoid and well-differentiated liposarcoma Well-differentiated and infantile hemangiopericytoma Well-differentiated malignant peripheral nerve sheath tumor\n\nPATIENT CHARACTERISTICS: Age: 21 and under Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine normal for age No hydronephrosis Cardiovascular: Shortening fraction greater than 28% Other: No HIV infection Not pregnant or nursing Effective contraception required of fertile women\n\nPRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy No prior nephrectomy (surgical correction of hydronephrosis allowed)"}, "identificationModule"=>{"nctId"=>"NCT00002804", "briefTitle"=>"Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Children With Advanced Soft Tissue Sarcoma", "organization"=>{"class"=>"NETWORK", "fullName"=>"Children's Oncology Group"}, "officialTitle"=>"Phase II Study of Neoadjuvant Vincristine, Ifosfamide, Doxorubicin, and AND G-CSF in Children With Advanced Stage Non-Rhabdomyosarcoma Soft Tissue Sarcomas", "orgStudyIdInfo"=>{"id"=>"9553"}, "secondaryIdInfos"=>[{"id"=>"POG-9553", "type"=>"OTHER", "domain"=>"Pediatric Oncology Group"}, {"id"=>"CDR0000064905", "type"=>"OTHER", "domain"=>"Clinical Trials.gov"}, {"id"=>"COG-P9953", "type"=>"OTHER", "domain"=>"Children's Oncology Group"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Chemotherapy Regimen", "description"=>"Induction (Weeks 1-6) Vincristine sulfate (1.5 mg/m2) day 1, Ifosfamide (3 grams/m2) days 1-3, Doxorubicin (30 mg/m2) days 1-2, filgrastim day 4. Weeks 2 and 3 - Vincristine sulfate (1.5 mg/m2) IV day 1, week 5 no chemotherapy. Evaluate for response. Local Control (Weeks 7-13) Conventional surgery and radiation therapy. Vincristine sulfate (1.5 mg/m2) IV day 1, Ifosfamide (3 grams/m2) days 1-3, Doxorubicin (30 mg/m2) days 1-2, filgrastim day 4. Treatment continues per protocol.", "interventionNames"=>["Biological: filgrastim", "Drug: doxorubicin hydrochloride", "Drug: ifosfamide", "Drug: mesna", "Drug: vincristine sulfate", "Procedure: conventional surgery", "Radiation: brachytherapy", "Radiation: low-LET cobalt-60 gamma ray therapy", "Radiation: low-LET electron therapy", "Radiation: low-LET photon therapy"]}], "interventions"=>[{"name"=>"filgrastim", "type"=>"BIOLOGICAL", "otherNames"=>["Granulocyte-Colony Stimulating Factor", "Neupogen", "G-CSF"], "armGroupLabels"=>["Chemotherapy Regimen"]}, {"name"=>"doxorubicin hydrochloride", "type"=>"DRUG", "otherNames"=>["Adriamycin", "NSC#123127"], "armGroupLabels"=>["Chemotherapy Regimen"]}, {"name"=>"ifosfamide", "type"=>"DRUG", "otherNames"=>["Isophosphamide", "IFEX"], "armGroupLabels"=>["Chemotherapy Regimen"]}, {"name"=>"mesna", "type"=>"DRUG", "otherNames"=>["Sodium 2-Mercaptoethane Sulfonate", "Mesnex", "Urimetexan", "NSC#113891"], "armGroupLabels"=>["Chemotherapy Regimen"]}, {"name"=>"vincristine sulfate", "type"=>"DRUG", "otherNames"=>["VCR", "Oncovin", "NSC#67574"], "armGroupLabels"=>["Chemotherapy Regimen"]}, {"name"=>"conventional surgery", "type"=>"PROCEDURE", "armGroupLabels"=>["Chemotherapy Regimen"]}, {"name"=>"brachytherapy", "type"=>"RADIATION", "armGroupLabels"=>["Chemotherapy Regimen"]}, {"name"=>"low-LET cobalt-60 gamma ray therapy", "type"=>"RADIATION", "armGroupLabels"=>["Chemotherapy Regimen"]}, {"name"=>"low-LET electron therapy", "type"=>"RADIATION", "armGroupLabels"=>["Chemotherapy Regimen"]}, {"name"=>"low-LET photon therapy", "type"=>"RADIATION", "armGroupLabels"=>["Chemotherapy Regimen"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"67214", "city"=>"Wichita", "state"=>"Kansas", "country"=>"United States", "facility"=>"Via Christi Regional Medical Center", "geoPoint"=>{"lat"=>37.69224, "lon"=>-97.33754}}, {"zip"=>"70112", "city"=>"New Orleans", "state"=>"Louisiana", "country"=>"United States", "facility"=>"MBCCOP - LSU Medical Center", "geoPoint"=>{"lat"=>29.95465, "lon"=>-90.07507}}, {"zip"=>"38105-2794", "city"=>"Memphis", "state"=>"Tennessee", "country"=>"United States", "facility"=>"Saint Jude Children's Research Hospital", "geoPoint"=>{"lat"=>35.14953, "lon"=>-90.04898}}, {"zip"=>"75230", "city"=>"Dallas", "state"=>"Texas", "country"=>"United States", "facility"=>"Medical City Dallas Hospital", "geoPoint"=>{"lat"=>32.78306, "lon"=>-96.80667}}, {"zip"=>"78236-5300", "city"=>"Lackland Air Force Base", "state"=>"Texas", "country"=>"United States", "facility"=>"San Antonio Military Pediatric Cancer and Blood Disorders Center", "geoPoint"=>{"lat"=>29.38663, "lon"=>-98.61797}}, {"zip"=>"78284-7811", "city"=>"San Antonio", "state"=>"Texas", "country"=>"United States", "facility"=>"University of Texas Health Science Center at San Antonio", "geoPoint"=>{"lat"=>29.42412, "lon"=>-98.49363}}, {"zip"=>"22908", "city"=>"Charlottesville", "state"=>"Virginia", "country"=>"United States", "facility"=>"Cancer Center, University of Virginia HSC", "geoPoint"=>{"lat"=>38.02931, "lon"=>-78.47668}}, {"zip"=>"00936-5067", "city"=>"San Juan", "country"=>"Puerto Rico", "facility"=>"University of Puerto Rico School of Medicine Medical Sciences Campus", "geoPoint"=>{"lat"=>18.46633, "lon"=>-66.10572}}, {"zip"=>"1211", "city"=>"Geneva", "country"=>"Switzerland", "facility"=>"Clinique de Pediatrie", "geoPoint"=>{"lat"=>46.20222, "lon"=>6.14569}}], "overallOfficials"=>[{"name"=>"Alberto S. Pappo, MD", "role"=>"STUDY_CHAIR", "affiliation"=>"St. Jude Children's Research Hospital"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Children's Oncology Group", "class"=>"NETWORK"}, "collaborators"=>[{"name"=>"National Cancer Institute (NCI)", "class"=>"NIH"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
