{ "FullStudy":{ "Rank":217774, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01517009", "OrgStudyIdInfo":{ "OrgStudyId":"DoCCS" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"Dutch trialregister", "SecondaryIdType":"Registry Identifier", "SecondaryIdDomain":"NTR2306" },{ "SecondaryId":"2007-007273-23", "SecondaryIdType":"EudraCT Number" } ] }, "Organization":{ "OrgFullName":"Jeroen Bosch Ziekenhuis", "OrgClass":"OTHER" }, "BriefTitle":"A Multicenter Phase II Study of Neoadjuvant Docetaxel, Cisplatin and Capecitabine and Protocolized Surgery in Resectable Gastric Cancer", "OfficialTitle":"A Multicenter Phase II Study of Neoadjuvant Docetaxel, Cisplatin and Capecitabine and Protocolized Surgery in Resectable Gastric Cancer", "Acronym":"DoCCS" }, "StatusModule":{ "StatusVerifiedDate":"June 2013", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"June 2008" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"November 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"May 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"October 21, 2011", "StudyFirstSubmitQCDate":"January 20, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"June 25, 2013", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"June 26, 2013", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Anneriet Dassen", "ResponsiblePartyInvestigatorTitle":"Ms A.E. Dassen, MD, Principle Investigator", "ResponsiblePartyInvestigatorAffiliation":"Jeroen Bosch Ziekenhuis" }, "LeadSponsor":{ "LeadSponsorName":"Jeroen Bosch Ziekenhuis", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Eindhoven Cancer Registry", "CollaboratorClass":"OTHER" } ] } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to determine the feasibility of chemotherapy, consisting of docetaxel, cisplatin and capecitabine given prior to surgery for stomach cancer. Furthermore, an extended type of removal of lymph nodes will be implemented." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Gastric Cancer" ] }, "KeywordList":{ "Keyword":[ "Neo-adjuvant chemotherapy", "D1extra-resection" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"50", "EnrollmentType":"Anticipated" } }, "ArmsInterventionsModule":{ "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Docetaxel", "InterventionDescription":"60 mg/m2, 1 gift every 3 weeks, in total 4 gifts", "InterventionOtherNameList":{ "InterventionOtherName":[ "Taxotere" ] } },{ "InterventionType":"Drug", "InterventionName":"cisplatin", "InterventionDescription":"60 mg/m2, one gift every three weeks, in total 4 gift" },{ "InterventionType":"Drug", "InterventionName":"Capecitabine", "InterventionDescription":"1875 mg/m2 in two equally divided doses day 1-14, repeated every three weeks, in total 4 cycles", "InterventionOtherNameList":{ "InterventionOtherName":[ "Xeloda" ] } },{ "InterventionType":"Procedure", "InterventionName":"D1extra-resection", "InterventionDescription":"An extended lymphadenectomy compared to a D1 resection for gastric cancer" } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"The number of patients with (serious) adverse events receiving the combination of 4 courses of docetaxel, cisplatin and capecitabine as neoadjuvant chemotherapy and standardized surgery in resectable localized or locally advanced gastric cancer.", "PrimaryOutcomeDescription":"Patients receive every 3 weeks a cycle of chemotherapy, in total 4 cylcles will be given. Surgery will be performed approximately 6 weeks after the last cycle.", "PrimaryOutcomeTimeFrame":"18 weeks" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"The number of patients receiving a D1-extra-resection as protocolized surgery in resectable gastric cancer", "SecondaryOutcomeTimeFrame":"30 days" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nIb-IVa histological proven resectable gastric adenocarcinoma, including gastro-oesophageal junction/cardia carcinoma Siewert 2 and 3\nASA 2 or less\nAge 18 years or more\nNo prior radio- or chemotherapy conflicting with the treatment of gastric cancer\nHaematology/Renal function/Liver function within designated range\nPatient's consent form obtained, signed and dated before beginning specific protocol procedures\nabsence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial\nbefore patient registration/randomization, written informed consent must be given according to GCP, WMO and local regulations.\n\nExclusion Criteria:\n\nPrevious or other current malignancies, with the exception of adequately treated in situ carcinoma of the cervix uteri or non-melanoma skin cancer\nOther current serious illness or medical conditions\nSevere cardiac illness (NYHA class III-IV)\nSignificant neurologic or psychiatric disorders\nUncontrolled infections\nActive DIC\nOther serious underlying medical conditions that could impair the ability of the patient to participate in the study\nKnown hypersensitivity to docetaxel (or any drug formulated with Polysorbate-80), or cisplatin or capecitabine or 5-FU\nDefinite contraindications for the use of corticosteroids\nUse of immunosuppressive or antiviral drugs\nAny other experimental drugs within a 4-week period prior to start of neoadjuvant chemotherapy and throughout the study period\nPregnant or lactating women\nPatients with reproductive potential not implementing adequate contraceptive measures", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "LocationList":{ "Location":[ { "LocationFacility":"VieCuri Hospital", "LocationCity":"Venlo", "LocationState":"Limburg", "LocationZip":"5912 BL", "LocationCountry":"Netherlands" },{ "LocationFacility":"Elkerliek Hospital", "LocationCity":"Helmond", "LocationState":"Noord Brabant", "LocationZip":"5700 AB", "LocationCountry":"Netherlands" },{ "LocationFacility":"Jeroen Bosch Hospital", "LocationCity":"Den Bosch", "LocationState":"Noord-Brabant", "LocationZip":"5200 ME", "LocationCountry":"Netherlands" },{ "LocationFacility":"Catharina Hospital", "LocationCity":"Eindhoven", "LocationState":"Noord-Brabant", "LocationZip":"5602 ZA", "LocationCountry":"Netherlands" },{ "LocationFacility":"Maxima Medical Centre", "LocationCity":"Veldhoven", "LocationState":"Noord-Brabant", "LocationZip":"5500 MB", "LocationCountry":"Netherlands" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000077143", "InterventionMeshTerm":"Docetaxel" },{ "InterventionMeshId":"D000069287", "InterventionMeshTerm":"Capecitabine" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000970", "InterventionAncestorTerm":"Antineoplastic Agents" },{ "InterventionAncestorId":"D000050257", "InterventionAncestorTerm":"Tubulin Modulators" },{ "InterventionAncestorId":"D000050256", "InterventionAncestorTerm":"Antimitotic Agents" },{ "InterventionAncestorId":"D000050258", "InterventionAncestorTerm":"Mitosis Modulators" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" },{ "InterventionAncestorId":"D000000964", "InterventionAncestorTerm":"Antimetabolites, Antineoplastic" },{ "InterventionAncestorId":"D000000963", "InterventionAncestorTerm":"Antimetabolites" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M377", "InterventionBrowseLeafName":"Capecitabine", "InterventionBrowseLeafAsFound":"Capecitabine", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M1668", "InterventionBrowseLeafName":"Docetaxel", "InterventionBrowseLeafAsFound":"Docetaxel", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M4765", "InterventionBrowseLeafName":"Cisplatin", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M24784", "InterventionBrowseLeafName":"Tubulin Modulators", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M24783", "InterventionBrowseLeafName":"Antimitotic Agents", "InterventionBrowseLeafRelevance":"low" },{ "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" } ] } } } } } }