{ "FullStudy":{ "Rank":217779, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01516944", "OrgStudyIdInfo":{ "OrgStudyId":"TOTTG030103" }, "Organization":{ "OrgFullName":"Hebei Medical University", "OrgClass":"OTHER" }, "BriefTitle":"Perioperative Chemotherapy for Potentially Resectable Gastric Cancer", "OfficialTitle":"Perioperative Tegafur Gimeracil Oteracil Potassium Capsule Plus Oxaliplatin Versus Capecitabine Plus Oxaliplatin in Patients With Localized Advanced Gastric Cancer" }, "StatusModule":{ "StatusVerifiedDate":"February 2020", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"February 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"April 2018", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"December 2018", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 10, 2012", "StudyFirstSubmitQCDate":"January 24, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"February 11, 2020", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"February 13, 2020", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Qun Zhao", "ResponsiblePartyInvestigatorTitle":"Principal Investigator", "ResponsiblePartyInvestigatorAffiliation":"Hebei Medical University" }, "LeadSponsor":{ "LeadSponsorName":"Hebei Medical University", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"Stage I：Neoadjuvant therapy\n\nTegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin is superior to surgery alone;Capecitabine plus oxaliplatin is non-inferiority to Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin\n\nStage II: Perioperative therapy\n\nPerioperative Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin is superior to adjuvant Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin alone;Capecitabine plus oxaliplatin regimen is noninferiority to Tegafur,Gimeracil and Oteracil Potassium Capsules plus oxaliplatin\nA regimen of Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin(SOX) and Capecitabine plus oxaliplatin(XELOX) improves survival among patients with incurable locally advanced or metastatic gastric cancer. The investigators assessed whether the addition of a perioperative regimen of SOX or XELOX regimen to adjuvant alone improves R0 resection rate and survival among patients with curable locally advanced gastric cancer." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Gastric Cancer" ] }, "KeywordList":{ "Keyword":[ "Tegafur，Gimeracil and Oteracil Potassium Capsules", "Capecitabine", "Oxaliplatin", "perioperative Chemotherapy", "Gastric Cancer" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2", "Phase 3" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"749", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"postoperative chemotherapy,SOX", "ArmGroupType":"Active Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Tegafur, Gimeracil and Oteracil Potassium Capsules；Oxaliplatin" ] } },{ "ArmGroupLabel":"Perioperative chemotherapy,SOX", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Tegafur, Gimeracil and Oteracil Potassium Capsules；Oxaliplatin" ] } },{ "ArmGroupLabel":"Perioperative chemotherapy,XELOX", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Oxaliplatin; Capecitabine" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Tegafur, Gimeracil and Oteracil Potassium Capsules；Oxaliplatin", "InterventionDescription":"Tegafur，Gimeracil and Oteracil Potassium Capsules 80 mg/m2 D1-D14 q3wk and Oxaliplatin 130 mg/m2 D1 q3wk for six cycles postoperation", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "postoperative chemotherapy,SOX" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "S-1", "Oxaliplatin" ] } },{ "InterventionType":"Drug", "InterventionName":"Tegafur, Gimeracil and Oteracil Potassium Capsules；Oxaliplatin", "InterventionDescription":"Tegafur，Gimeracil and Oteracil Potassium Capsules 80mg/㎡ ,D1-D14 q3wk and Oxaliplatin,130 mg/㎡ D1 q3wk for two cycles preoperation, Tegafur，Gimeracil and Oteracil Potassium Capsules ,80 mg/㎡ D1-D14 q3wk and Oxaliplatin,130 mg/㎡ D1 q3wk for six cycles postoperation", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Perioperative chemotherapy,SOX" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "S-1", "Oxaliplatin" ] } },{ "InterventionType":"Drug", "InterventionName":"Oxaliplatin; Capecitabine", "InterventionDescription":"Capecitabine,2000 mg/㎡ D1-D14 q3wk and Oxaliplatin,130 mg/㎡ D1 q3wk for two cycle pre-operation, Capecitabine,2000 mg/㎡ D1-D14 q3wk and Oxaliplatin,130 mg/m2 D1 q3wk for six cycles postoperation", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Perioperative chemotherapy,XELOX" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Oxaliplatin", "Capecitabine" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Disease-free survival(DFS)", "PrimaryOutcomeTimeFrame":"3 year" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Objective response rate (ORR)", "SecondaryOutcomeTimeFrame":"At the end of the study" },{ "SecondaryOutcomeMeasure":"Disease control rate (DCR)", "SecondaryOutcomeDescription":"To Assess disease control rate (DCR) as defined CR + PR + SD assessed by RECIST criteria", "SecondaryOutcomeTimeFrame":"At the end of the study" },{ "SecondaryOutcomeMeasure":"Down staging rate", "SecondaryOutcomeDescription":"After the pathological examination of resected specimen", "SecondaryOutcomeTimeFrame":"Within 3 weeks after surgery" },{ "SecondaryOutcomeMeasure":"Overall survival (OS)", "SecondaryOutcomeTimeFrame":"5 year" },{ "SecondaryOutcomeMeasure":"Adverse events", "SecondaryOutcomeDescription":"Investigators graded all adverse events and toxic effects according to the National Cancer Institute's Common Toxicity Criteria, version 2.0. The number of Participants with adverse events will be recorded at each treatment visit.", "SecondaryOutcomeTimeFrame":"Side effects during observation" },{ "SecondaryOutcomeMeasure":"R0-resection rate", "SecondaryOutcomeDescription":"After the pathological examination of resected specimen", "SecondaryOutcomeTimeFrame":"Within 3 weeks after surgery" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nAge 18 -75\nHistologically or cytologically proven in operable advanced gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction)\nECOG performance status ≦2\nTumor stage T3/4NxM0\nNo distant metastasis (M0)\n\nExclusion Criteria:\n\nHistory of hypersensitivity to fluoropyrimidines, Tegafur，Gimeracil and Oteracil Potassium Capsules , capecitabine, oxaliplatin or the ingredients of this product\nInadequate hematopoietic function： WBC≦4,000/mm3; ANC≦2,000/mm3; Platelet≦100,000/mm3\nInadequate organ function which is defined as below:\n\nTotal bilirubin >2 pper limit of normal range (ULN); ALT / AST > 2.5 upper limit of normal range (ULN) (>5.0 x ULN if hepatic metastasis); serum creatinine > 1.2 mg/dL, and Ccr > 60 ml/min (estimated by Cockcroft-Gault formulation);\n\nSymptomatic peripheral neuropathy\nReceiving a concomitant treatment with other fluoropyrimidines\nPregnancy or lactation women, or women with suspected pregnancy or men unless using a reliable and appropriate contraceptive method.\nMental status is not fit for chemotherapy therapy presence of serious concomitant illness which might be aggravated by study medication:\nActive cardiac disease e.g. decompensate myocardial infarction within the 6-month period preceding entry into the study.\nHistory of ventricular arrhythmia or congestive heart failure.\nSignificant co-morbid medical conditions, including, but not limited to, Chronic obstructive pulmonary disease, interstitial pneumonia ,pulmonary fibrosis, heart failure, renal failure, hepatic failure, haemorrhagic peptic ulcer, mechanical or paralytic ileus, or poorly controlled diabetes.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"75 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Qun Zhao, Doctor", "OverallOfficialAffiliation":"Hebei Medical University", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Department of General Surgery", "LocationCity":"Shijiazhuang", "LocationState":"Hebei", "LocationZip":"050011", "LocationCountry":"China" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000069287", "InterventionMeshTerm":"Capecitabine" },{ "InterventionMeshId":"D000005641", "InterventionMeshTerm":"Tegafur" },{ "InterventionMeshId":"D000077150", "InterventionMeshTerm":"Oxaliplatin" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000964", "InterventionAncestorTerm":"Antimetabolites, Antineoplastic" },{ "InterventionAncestorId":"D000000963", "InterventionAncestorTerm":"Antimetabolites" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" },{ "InterventionAncestorId":"D000000970", "InterventionAncestorTerm":"Antineoplastic Agents" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M377", "InterventionBrowseLeafName":"Capecitabine", "InterventionBrowseLeafAsFound":"Capecitabine", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M1674", "InterventionBrowseLeafName":"Oxaliplatin", "InterventionBrowseLeafAsFound":"Oxaliplatin", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M7343", "InterventionBrowseLeafName":"Tegafur", "InterventionBrowseLeafAsFound":"Tegafur", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M2862", "InterventionBrowseLeafName":"Antimetabolites", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"ANeo", "InterventionBrowseBranchName":"Antineoplastic Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000013274", "ConditionMeshTerm":"Stomach Neoplasms" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000005770", "ConditionAncestorTerm":"Gastrointestinal Neoplasms" },{ "ConditionAncestorId":"D000004067", "ConditionAncestorTerm":"Digestive System Neoplasms" },{ "ConditionAncestorId":"D000009371", "ConditionAncestorTerm":"Neoplasms by Site" },{ "ConditionAncestorId":"D000009369", "ConditionAncestorTerm":"Neoplasms" },{ "ConditionAncestorId":"D000004066", "ConditionAncestorTerm":"Digestive System Diseases" },{ "ConditionAncestorId":"D000005767", "ConditionAncestorTerm":"Gastrointestinal Diseases" },{ "ConditionAncestorId":"D000013272", "ConditionAncestorTerm":"Stomach Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M14647", "ConditionBrowseLeafName":"Stomach Neoplasms", "ConditionBrowseLeafAsFound":"Gastric Cancer", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M7469", "ConditionBrowseLeafName":"Gastrointestinal Neoplasms", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M5839", "ConditionBrowseLeafName":"Digestive System Neoplasms", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M7466", "ConditionBrowseLeafName":"Gastrointestinal Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M5838", "ConditionBrowseLeafName":"Digestive System Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M14645", "ConditionBrowseLeafName":"Stomach Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T5511", "ConditionBrowseLeafName":"Stomach Cancer", "ConditionBrowseLeafAsFound":"Gastric Cancer", "ConditionBrowseLeafRelevance":"high" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC04", "ConditionBrowseBranchName":"Cancers and Other Neoplasms" },{ "ConditionBrowseBranchAbbrev":"BC06", "ConditionBrowseBranchName":"Digestive System Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"Rare", "ConditionBrowseBranchName":"Rare Diseases" } ] } } } } } }