{ "FullStudy":{ "Rank":217776, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01516983", "OrgStudyIdInfo":{ "OrgStudyId":"BD-IC-IV04" }, "Organization":{ "OrgFullName":"Betta Pharmaceuticals Co., Ltd.", "OrgClass":"INDUSTRY" }, "BriefTitle":"Icotinib Combined With WBRT For NSCLC Patients With Brain Metastases and EGFR Mutation", "OfficialTitle":"A Single Center, Open Label, Dose-Finding Study to Determine the Safety of Icotinib in Combination With Whole Brain Radiation Therapy For NSCLC Patients With Brain Metastases and EGFR Mutation." }, "StatusModule":{ "StatusVerifiedDate":"February 2014", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"December 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"June 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"December 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 10, 2012", "StudyFirstSubmitQCDate":"January 19, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"February 13, 2014", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"February 17, 2014", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Betta Pharmaceuticals Co., Ltd.", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to evaluate the safety and tolerability of Icotinib at different dose levels in combination with whole brain radiotherapy for NSCLC patients with brain metastases and EGFR mutation.", "DetailedDescription":"The long-term control of brain metastases becomes a clinical challenge. Whole brain radiotherapy, the standard treatment for patients with multiple brain metastases, can only bring a modest survival improvement around 3-6 months. EGFR-TKIs like icotinib with its proven activity in non-small cell lung cancer may provide clinical benefits in such patients." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Non-small Cell Lung Cancer", "Brain Metastases" ] }, "KeywordList":{ "Keyword":[ "Safety", "EGFR-TKI", "NSCLC", "Icotinib", "WBRT" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 1", "Phase 2" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"15", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Icotinib+WBRT", "ArmGroupType":"Experimental", "ArmGroupDescription":"Standard whole brain radiotherapy plus icotinib, which is designed to administered at 5 dose according to \"3+3\" until disease progression or intolerable toxicity.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: icotinib", "Radiation: Whole brain radiotherapy" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"icotinib", "InterventionDescription":"Level 1: Standard whole brain radiation therapy plus icotinib 125 mg Tid (375 mg per day) from day1 until disease progression or intolerable toxicity.\n\nLevel 2: Standard whole brain radiation therapy plus icotinib 250 mg Tid (750 mg per day) from day1 until disease progression or intolerable toxicity.\n\nLevel 3: Standard whole brain radiation therapy plus icotinib 375 mg Tid (1125 mg per day) from day1 until disease progression or intolerable toxicity.\n\nLevel 4:Standard whole brain radiation therapy plus icotinib 500 mg Tid (1500 mg per day) from day1 until disease progression or intolerable toxicity.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Icotinib+WBRT" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "BPI-2009, Conmana" ] } },{ "InterventionType":"Radiation", "InterventionName":"Whole brain radiotherapy", "InterventionDescription":"Whole Brain Radiation Therapy (WBRT) for total dose of 37.5Gy in 15 daily fractions beginning after Day 7.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Icotinib+WBRT" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "RT", "XRT", "Radiotherapy", "WBRT" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Safety and tolerability", "PrimaryOutcomeDescription":"All cause adverse events (AEs) and serious adverse events (SAEs)", "PrimaryOutcomeTimeFrame":"6-12 months" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Neurological progression-free survival", "SecondaryOutcomeDescription":"All cause neurological progress or mortality", "SecondaryOutcomeTimeFrame":"3-6 month" },{ "SecondaryOutcomeMeasure":"Progression-free survival", "SecondaryOutcomeDescription":"All cause progress or mortality", "SecondaryOutcomeTimeFrame":"3-6 months" },{ "SecondaryOutcomeMeasure":"Overall survival", "SecondaryOutcomeDescription":"All cause mortality", "SecondaryOutcomeTimeFrame":"6-12 months" },{ "SecondaryOutcomeMeasure":"Response rate", "SecondaryOutcomeTimeFrame":"3-6 month" },{ "SecondaryOutcomeMeasure":"Quality of life measured by FACT-L/LCS 4.0", "SecondaryOutcomeTimeFrame":"1 year" },{ "SecondaryOutcomeMeasure":"Neurocognitive effects", "SecondaryOutcomeDescription":"Evaluated according to Mini-Mental Status Examination", "SecondaryOutcomeTimeFrame":"3-6 months" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nHistological or cytological confirmation of non-small cell lung cancer (NSCLC).\nDiagnosis of brain metastases on a Gadolinium-enhanced MRI. More than 3 sites of intracranial metastases, or the longest diameter of the intracranial lesion is more than 3cm.\nPositive EGFR mutation.\n\nExclusion Criteria:\n\nPrevious usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.\nCSF or MRI findings consistent with metastases of spinal cord, meninges or meningeal.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"75 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"You Lu", "OverallOfficialAffiliation":"West China Hospital", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"West China Hospital", "LocationCity":"Chengdu", "LocationState":"Sichuan", "LocationZip":"610041", "LocationCountry":"China" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000009362", "ConditionMeshTerm":"Neoplasm Metastasis" },{ "ConditionMeshId":"D000001932", "ConditionMeshTerm":"Brain Neoplasms" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000009371", "ConditionAncestorTerm":"Neoplasms by Site" },{ "ConditionAncestorId":"D000009369", "ConditionAncestorTerm":"Neoplasms" },{ "ConditionAncestorId":"D000009385", "ConditionAncestorTerm":"Neoplastic Processes" },{ "ConditionAncestorId":"D000010335", "ConditionAncestorTerm":"Pathologic Processes" },{ "ConditionAncestorId":"D000016543", "ConditionAncestorTerm":"Central Nervous System Neoplasms" },{ "ConditionAncestorId":"D000009423", "ConditionAncestorTerm":"Nervous System Neoplasms" },{ "ConditionAncestorId":"D000001927", "ConditionAncestorTerm":"Brain Diseases" },{ "ConditionAncestorId":"D000002493", "ConditionAncestorTerm":"Central Nervous System Diseases" },{ "ConditionAncestorId":"D000009422", "ConditionAncestorTerm":"Nervous System Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M10890", "ConditionBrowseLeafName":"Neoplasm Metastasis", "ConditionBrowseLeafAsFound":"Metastases", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M9755", "ConditionBrowseLeafName":"Lung Neoplasms", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4128", "ConditionBrowseLeafName":"Carcinoma, Non-Small-Cell Lung", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3791", "ConditionBrowseLeafName":"Brain Neoplasms", "ConditionBrowseLeafAsFound":"Brain Metastases", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M10913", "ConditionBrowseLeafName":"Neoplastic Processes", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M17520", "ConditionBrowseLeafName":"Central Nervous System Neoplasms", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10950", "ConditionBrowseLeafName":"Nervous System Neoplasms", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3786", "ConditionBrowseLeafName":"Brain Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4325", "ConditionBrowseLeafName":"Central Nervous System 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":"BC08", "ConditionBrowseBranchName":"Respiratory Tract (Lung and Bronchial) Diseases" },{ "ConditionBrowseBranchAbbrev":"BC10", "ConditionBrowseBranchName":"Nervous System Diseases" } ] } } } } } }