{ "FullStudy":{ "Rank":218222, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01511146", "OrgStudyIdInfo":{ "OrgStudyId":"AA-1023" }, "Organization":{ "OrgFullName":"Copenhagen University Hospital at Herlev", "OrgClass":"OTHER" }, "BriefTitle":"Intrahepatic Chemotherapy to Patients With Non-resectable Liver Metastases From Solid Tumor", "OfficialTitle":"Intrahepatic and Systemic Chemotherapy Together With Antibody to Patients With Non-resectable Liver Metastases From Solid Tumors" }, "StatusModule":{ "StatusVerifiedDate":"January 2012", "OverallStatus":"Unknown status", "LastKnownStatus":"Recruiting", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"July 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"July 2015", "PrimaryCompletionDateType":"Anticipated" }, "CompletionDateStruct":{ "CompletionDate":"July 2016", "CompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"August 4, 2011", "StudyFirstSubmitQCDate":"January 12, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 18, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 18, 2012", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 19, 2012", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Copenhagen University Hospital at Herlev", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to see if treatment with intrahepatic chemotherapy is a good options in patients with liver metastases. If the patients have colorectal cancer and never had got chemotherapy the investigators will use oxaliplatin together with capecitabine. If the patient is K-RAS wild type the investigators will add cetuximab. In patients who had received oxaliplatin or in patients with other cancers the investigators will use mitomycin and gemcitabine together with capecitabine.", "DetailedDescription":"Two regiment are used: N.B. The two regiments will be reported separately\n\nMitomycin + Gemcitabine intrahepatic together with Capecitabine. This treatment can be offered patients with solid tumors where all standard treatments have been used. The patients are not allowed to have extrahepatic disease. The purpose of the treatment are to prolonged life.\nFOLFOX where oxaliplatin is given intrahepatic each second time. The treatment are only for patients with colorectal cancer where cure is possible but resection straight ahead is not possible. The patients are allowed to have their colorectal cancer in situ for operation latter on. If the patients are KRAS Wild-type, cetuximab are added." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Liver Metastasis" ] }, "KeywordList":{ "Keyword":[ "oxaliplatin", "mitomycin", "gemcitabine", "intrahepatic", "liver metastasis", "response in liver metastasis", "downsized to operation" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"100", "EnrollmentType":"Anticipated" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Mitomycin+Gemcitabine", "ArmGroupType":"Experimental", "ArmGroupDescription":"Intrahepatic treatment, where all standard treatments have been used", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Oxaliplatin", "Drug: Mitomycin + Gemcitabine" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Oxaliplatin", "InterventionDescription":"oxaliplatin 85 mg/m2 in 10 minutes", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Mitomycin+Gemcitabine" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Mitomycin c", "Gemcitabine" ] } },{ "InterventionType":"Drug", "InterventionName":"Mitomycin + Gemcitabine", "InterventionDescription":"Mitomycin 5 mg/m2 Gemcitabine 1000 mg/m2", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Mitomycin+Gemcitabine" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Mitomycin c", "Gemcitabine" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"tumor response according to RECIST 1.1. Number of patients with CR, PR, SD and PR will be recorded.", "PrimaryOutcomeTimeFrame":"5 years" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Progression free survival, adverse events", "SecondaryOutcomeTimeFrame":"5 years" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nliver metastasis\nsolid tumor\n\nExclusion Criteria:\n\npoor performance", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Finn O Larsen, M.D. , Ph.D", "OverallOfficialAffiliation":"Unaffliated", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Herlev Hospital", "LocationStatus":"Recruiting", "LocationCity":"Herlev", "LocationZip":"2730", "LocationCountry":"Denmark", "LocationContactList":{ "LocationContact":[ { "LocationContactName":"Ole Larsen, ph.d., MD", "LocationContactRole":"Contact", "LocationContactPhone":"+4538682329", "LocationContactEMail":"olelar02@heh.regionh.dk" },{ "LocationContactName":"Ole Larsen, ph.d., MD", "LocationContactRole":"Principal Investigator" } ] } } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"C000056507", "InterventionMeshTerm":"Gemcitabine" },{ "InterventionMeshId":"D000077150", "InterventionMeshTerm":"Oxaliplatin" },{ "InterventionMeshId":"D000008937", "InterventionMeshTerm":"Mitomycins" },{ "InterventionMeshId":"D000016685", "InterventionMeshTerm":"Mitomycin" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000964", "InterventionAncestorTerm":"Antimetabolites, Antineoplastic" },{ "InterventionAncestorId":"D000000963", "InterventionAncestorTerm":"Antimetabolites" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" },{ "InterventionAncestorId":"D000000970", "InterventionAncestorTerm":"Antineoplastic Agents" },{ "InterventionAncestorId":"D000000998", "InterventionAncestorTerm":"Antiviral Agents" },{ "InterventionAncestorId":"D000000890", "InterventionAncestorTerm":"Anti-Infective Agents" },{ "InterventionAncestorId":"D000004791", "InterventionAncestorTerm":"Enzyme Inhibitors" },{ "InterventionAncestorId":"D000007166", "InterventionAncestorTerm":"Immunosuppressive Agents" },{ "InterventionAncestorId":"D000007155", "InterventionAncestorTerm":"Immunologic Factors" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000000903", "InterventionAncestorTerm":"Antibiotics, Antineoplastic" },{ "InterventionAncestorId":"D000000477", "InterventionAncestorTerm":"Alkylating Agents" },{ "InterventionAncestorId":"D000019384", "InterventionAncestorTerm":"Nucleic Acid Synthesis Inhibitors" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M1674", "InterventionBrowseLeafName":"Oxaliplatin", "InterventionBrowseLeafAsFound":"Oxaliplatin", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M10486", "InterventionBrowseLeafName":"Mitomycins", "InterventionBrowseLeafAsFound":"Mitomycin", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M17636", "InterventionBrowseLeafName":"Mitomycin", "InterventionBrowseLeafAsFound":"Mitomycin", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M223958", "InterventionBrowseLeafName":"Gemcitabine", "InterventionBrowseLeafAsFound":"Gemcitabine", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M2862", "InterventionBrowseLeafName":"Antimetabolites", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2895", "InterventionBrowseLeafName":"Antiviral Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2795", "InterventionBrowseLeafName":"Anti-Infective Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M8795", "InterventionBrowseLeafName":"Immunosuppressive Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M8784", "InterventionBrowseLeafName":"Immunologic Factors", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2803", "InterventionBrowseLeafName":"Anti-Bacterial Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2805", "InterventionBrowseLeafName":"Antibiotics, Antitubercular", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2401", "InterventionBrowseLeafName":"Alkylating Agents", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"ANeo", "InterventionBrowseBranchName":"Antineoplastic Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"Infe", "InterventionBrowseBranchName":"Anti-Infective Agents" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000009362", "ConditionMeshTerm":"Neoplasm Metastasis" },{ "ConditionMeshId":"D000016609", "ConditionMeshTerm":"Neoplasms, Second Primary" },{ "ConditionMeshId":"D000008113", "ConditionMeshTerm":"Liver Neoplasms" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000009385", "ConditionAncestorTerm":"Neoplastic Processes" },{ "ConditionAncestorId":"D000009369", "ConditionAncestorTerm":"Neoplasms" },{ "ConditionAncestorId":"D000010335", "ConditionAncestorTerm":"Pathologic Processes" },{ "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":"M10890", "ConditionBrowseLeafName":"Neoplasm Metastasis", "ConditionBrowseLeafAsFound":"Metastases", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M17572", "ConditionBrowseLeafName":"Neoplasms, Second Primary", "ConditionBrowseLeafAsFound":"Metastases", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M9696", "ConditionBrowseLeafName":"Liver Neoplasms", "ConditionBrowseLeafAsFound":"Liver Metastases", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M10913", "ConditionBrowseLeafName":"Neoplastic Processes", "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":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC06", "ConditionBrowseBranchName":"Digestive System Diseases" } ] } } } } } }