{ "FullStudy":{ "Rank":218125, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01512407", "OrgStudyIdInfo":{ "OrgStudyId":"CRE-2011.236-T" }, "Organization":{ "OrgFullName":"Chinese University of Hong Kong", "OrgClass":"OTHER" }, "BriefTitle":"RCT on Adjuvant TACE After Hepatectomy for HCC", "OfficialTitle":"Randomised Controlled Trial on Adjuvant Transarterial Chemoembolisation After Curative Hepatectomy for Hepatocellular Carcinoma", "Acronym":"A-TECH" }, "StatusModule":{ "StatusVerifiedDate":"February 2015", "OverallStatus":"Unknown status", "LastKnownStatus":"Recruiting", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"January 2017", "PrimaryCompletionDateType":"Anticipated" }, "CompletionDateStruct":{ "CompletionDate":"January 2018", "CompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"January 14, 2012", "StudyFirstSubmitQCDate":"January 14, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 19, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"February 2, 2015", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"February 4, 2015", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Cheung Yue Sun", "ResponsiblePartyInvestigatorTitle":"Dr Cheung Yue Sun", "ResponsiblePartyInvestigatorAffiliation":"Chinese University of Hong Kong" }, "LeadSponsor":{ "LeadSponsorName":"Chinese University of Hong Kong", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"We hypothesise that the use of transarterial chemoembolisation (TACE) after liver resection in patients with hepatocellular carcinoma can eradicate residual cancer cells in the liver and thus improve survival. The aim of this study is to compare the survival of patients undergoing liver resection plus post-operative TACE versus liver resection alone.", "DetailedDescription":"Liver resection is the mainstay of curative treatment for hepatocellular carcinoma (HCC). However, recurrence is common after surgery and most occurs in the liver. Transarterial chemoembolisation (TACE) is an effective palliative treatment for HCC. It involves the infusion of chemotherapeutic agent admixed with iodised oil followed by embolisation of the hepatic arterial flow using small particles. This procedures allows application of smaller dose of chemotherapy concentrated to the liver and thus is well tolerated with minimal side effects. We conduct a randomised controlled trial evaluating the efficacy of using TACE after hepatectomy in HCC patients." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Hepatocellular Carcinoma" ] }, "KeywordList":{ "Keyword":[ "Hepatocellular Carcinoma", "Randomised controlled trial", "Transarterial chemoembolisation" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 3" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"144", "EnrollmentType":"Anticipated" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Hepatectomy plus TACE", "ArmGroupType":"Experimental", "ArmGroupDescription":"Transarterial chemoembolisation will be performed 4 to 6 weeks after hepatectomy", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Procedure: Transarterial chemoembolisation using cisplatin-lipiodol mixture" ] } },{ "ArmGroupLabel":"Hepatectomy alone", "ArmGroupType":"No Intervention" } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Procedure", "InterventionName":"Transarterial chemoembolisation using cisplatin-lipiodol mixture", "InterventionDescription":"Cisplatin-lipiodol mixture was infused through catheter placed at hepatic artery followed by gelfoam embolisation. This is performed 4 to 6 weeks after surgery", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Hepatectomy plus TACE" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"1-year recurrence rate", "PrimaryOutcomeDescription":"The 1-year recurrence rate after hepatectomy in both arms of study were compared", "PrimaryOutcomeTimeFrame":"1-year after hepatectomy" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Disease-free survival", "SecondaryOutcomeTimeFrame":"5 years after operation" },{ "SecondaryOutcomeMeasure":"Overall Survival", "SecondaryOutcomeTimeFrame":"5-year after surgery" },{ "SecondaryOutcomeMeasure":"Complications of transarterial chemoembolisation", "SecondaryOutcomeTimeFrame":"3-month after transarterial chemoembolisation" },{ "SecondaryOutcomeMeasure":"Health-related quality of life assessment", "SecondaryOutcomeDescription":"The quality of life assessment was measured by Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire (Chinese version 3)", "SecondaryOutcomeTimeFrame":"1-year after surgery" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nHCC patients received curative hepatectomy with negative resection margin\nAge from 18 to 70\nChild-Pugh class A\nASA class I to III\nECOG performance status Grade 0 or 1\n\nExclusion Criteria:\n\nPatients receiving concomitant local ablation or previous TACE\nMain portal vein tumour thrombus extraction during hepatectomy\nTumour arising from caudate lobe\nPresence of extra-hepatic disease\nVery early HCC with solitary tumour and size < 2cm\nImpaired liver function with either clinically detected ascites, hepatic encephalopathy, serum albumin < 25g/L or bilirubin > 50micromol/L\nRenal impairment with creatinine > 200micromol/L\nSevere concurrent medical illness persisting > 6 weeks after hepatectomy\nHistory of other cancer\nHepatic artery anomaly making TACE not possible\nAllergy to cisplatin or lipiodol\nPregnant woman\nInformed consent not available", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"70 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "CentralContactList":{ "CentralContact":[ { "CentralContactName":"Yue Sun Cheung, MBChB", "CentralContactRole":"Contact", "CentralContactPhone":"(852) 26321411", "CentralContactEMail":"yuesun@surgery.cuhk.edu.hk" } ] }, "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Yue Sun Cheung, MBChB", "OverallOfficialAffiliation":"Chinese University of Hong Kong", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Prince of Wales Hospital", "LocationStatus":"Recruiting", "LocationCity":"Hong Kong", "LocationCountry":"China", "LocationContactList":{ "LocationContact":[ { "LocationContactName":"Yue Sun Cheung, MBChB", "LocationContactRole":"Contact", "LocationContactPhone":"(852) 26321411", "LocationContactEMail":"yuesun@surgery.cuhk.edu.hk" },{ "LocationContactName":"Yue Sun Cheung, MBChB", "LocationContactRole":"Principal Investigator" } ] } } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000004998", "InterventionMeshTerm":"Ethiodized Oil" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000970", "InterventionAncestorTerm":"Antineoplastic Agents" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M4765", "InterventionBrowseLeafName":"Cisplatin", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M6729", "InterventionBrowseLeafName":"Ethiodized Oil", "InterventionBrowseLeafAsFound":"Lipiodol", "InterventionBrowseLeafRelevance":"high" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"ANeo", "InterventionBrowseBranchName":"Antineoplastic Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000002277", "ConditionMeshTerm":"Carcinoma" },{ "ConditionMeshId":"D000006528", "ConditionMeshTerm":"Carcinoma, Hepatocellular" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000009375", "ConditionAncestorTerm":"Neoplasms, Glandular and Epithelial" },{ "ConditionAncestorId":"D000009370", "ConditionAncestorTerm":"Neoplasms by Histologic Type" },{ "ConditionAncestorId":"D000009369", "ConditionAncestorTerm":"Neoplasms" },{ "ConditionAncestorId":"D000000230", "ConditionAncestorTerm":"Adenocarcinoma" },{ "ConditionAncestorId":"D000008113", "ConditionAncestorTerm":"Liver Neoplasms" },{ "ConditionAncestorId":"D000004067", "ConditionAncestorTerm":"Digestive System Neoplasms" },{ "ConditionAncestorId":"D000009371", "ConditionAncestorTerm":"Neoplasms by Site" },{ "ConditionAncestorId":"D000004066", "ConditionAncestorTerm":"Digestive System Diseases" },{ "ConditionAncestorId":"D000008107", "ConditionAncestorTerm":"Liver Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M4116", "ConditionBrowseLeafName":"Carcinoma", "ConditionBrowseLeafAsFound":"Carcinoma", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M8196", "ConditionBrowseLeafName":"Carcinoma, Hepatocellular", "ConditionBrowseLeafAsFound":"Hepatocellular Carcinoma", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M10903", "ConditionBrowseLeafName":"Neoplasms, Glandular and Epithelial", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10898", "ConditionBrowseLeafName":"Neoplasms by Histologic Type", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M2166", "ConditionBrowseLeafName":"Adenocarcinoma", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9696", "ConditionBrowseLeafName":"Liver Neoplasms", "ConditionBrowseLeafRelevance":"low" },{ "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":"M9690", "ConditionBrowseLeafName":"Liver Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC04", "ConditionBrowseBranchName":"Cancers and Other Neoplasms" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC06", "ConditionBrowseBranchName":"Digestive System Diseases" } ] } } } } } }