{ "FullStudy":{ "Rank":217651, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01518621", "OrgStudyIdInfo":{ "OrgStudyId":"RadEr" }, "Organization":{ "OrgFullName":"Oslo University Hospital", "OrgClass":"OTHER" }, "BriefTitle":"Whole Brain Radiation With or Without Erlotinib for Brain Metastases From Non-Small Cell Lung Cancer", "OfficialTitle":"Whole Brain Radiation With or Without Erlotinib for Brain Metastases From Non-Small Cell Lung Cancer", "Acronym":"RadEr" }, "StatusModule":{ "StatusVerifiedDate":"March 2019", "OverallStatus":"Terminated", "WhyStopped":"Slow accrual", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"May 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"December 10, 2017", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"December 10, 2018", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 19, 2012", "StudyFirstSubmitQCDate":"January 25, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 26, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"March 12, 2019", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"March 13, 2019", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Odd Terje Brustugun", "ResponsiblePartyInvestigatorTitle":"Senior consultant", "ResponsiblePartyInvestigatorAffiliation":"Oslo University Hospital" }, "LeadSponsor":{ "LeadSponsorName":"Oslo University Hospital", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"To determine if erlotinib given orally along with concurrent whole brain irradiation in lung cancer patients with brain metastases improves median overall survival and enhances local control compared to those treated with WBRT alone, without significantly increasing the risk of side effects or lowering quality of life.", "DetailedDescription":"Endpoints\n\nPrimary:\n\n• To determine if erlotinib given orally along with concurrent WBRT in lung cancer patients with brain metastases, improves median overall survival compared to those treated with WBRT alone.\n\nSecondary:\n\nTo confirm the safety profile of erlotinib along with concurrent WBRT, in the context of treating central nervous system malignancies.\nTo evaluate if erlotinib along with concurrent WBRT increases local control rate as measured by MRI at 8 weeks, compared to WBRT alone.\nTo evaluate if erlotinib along with concurrent WBRT increases time to neurologic progression of disease based on neuropsychological assessment at baseline, at 8 and 20 weeks after WBRT.\nTo evaluate quality of life parameters in patients treated with WBRT alone vs concomitant erlotinib and WBRT\nTo evaluate if mutation status has impact on the above mentioned parameters Trial design Open multicenter randomized phase II trial. Patients Patients > 18 years with histologically confirmed NSCLC and brain metastases verified on either CT or MRI, not eligible for neurosurgery or stereotactic radiation therapy.\n\nTrial treatment Patients will be randomized 1:1 to either treatment arm A or B.\n\nArm A: WBRT 3 Gy x10 alone.\nArm B: WBRT 3 Gy x10 and erlotinib given concomitantly, 150 mg p.o. daily from the day before radiation, until the last day of radiation.\n\nNumber of patients 150 patients will be included, 75 in each arm" }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Cancer" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"25", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Radiotherapy alone", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Total brain irradiation, 3Gy x10", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Radiation: Radiation" ] } },{ "ArmGroupLabel":"Radiation plus erlotinib", "ArmGroupType":"Experimental", "ArmGroupDescription":"Total brain irradiation, 3Gy x10 plus erlotinib 150 mg q d from radiation day -1 through last day of irradiation", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Radiation plus erlotinib" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Radiation", "InterventionName":"Radiation", "InterventionDescription":"Whole brain radiation", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Radiotherapy alone" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Whole brain radiation therapy" ] } },{ "InterventionType":"Drug", "InterventionName":"Radiation plus erlotinib", "InterventionDescription":"Radiation 3Gy x10 plus erlotinib 150 mg q d, from the day before radiation start, through last day of irradiation", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Radiation plus erlotinib" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Whole brain radiation therapy and tyrosin kinase inhibitor" ] } } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria: Histologically or cytologically confirmed advanced non-small cell lung cancer (NSCLC) meeting 1 of the following criteria:\n\nNewly diagnosed multiple brain metastases not suitable for first-line chemotherapy\nRelapsed NSCLC with newly diagnosed multiple brain metastases\n\nRelapsed NSCLC after second-line or more chemotherapy regimens with newly diagnosed multiple brain metastases\n\nDiagnosis of brain metastases confirmed by MRI (or CT if MRI is not available/possible) within the past 4 weeks\nSymptoms attributable to brain metastases\nPatients who have undergone craniotomy with incomplete resection are eligible\nClinician's opinion that whole-brain radiotherapy (WBRT) will be beneficial\nECOG PS 0-2\nAge above 18 years\nSerum bilirubin < 2 times upper limit of normal (ULN)\nAST and ALT < 2 times ULN (< 5 times ULN if liver metastases are present)\nCreatinine < 1.5 times ULN\nAble to take oral medication\nNot pregnant or nursing\nNegative pregnancy test\nFertile patients must use effective contraception\nNo other prior or concurrent malignant disease likely to interfere with study treatment or comparisons\n\nExclusion Criteria:\n\nMore than 3 sites (organ systems) of extracranial metastases\nEvidence of solitary brain metastasis on MRI that can be treated with surgical resection, radiosurgery, or stereotactic radiotherapy\nEvidence of other significant laboratory finding or concurrent uncontrolled medical illness, that in the opinion of the investigator, would interfere with study treatment or results comparison or render the patient at high risk for treatment complications", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"100 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Odd Terje Brustugun, MD PhD", "OverallOfficialAffiliation":"Norwegian Radium Hospital", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"The Norwegian Radium Hospital", "LocationCity":"Oslo", "LocationZip":"N-0310", "LocationCountry":"Norway" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000069347", "InterventionMeshTerm":"Erlotinib Hydrochloride" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000970", "InterventionAncestorTerm":"Antineoplastic Agents" },{ "InterventionAncestorId":"D000047428", "InterventionAncestorTerm":"Protein Kinase Inhibitors" },{ "InterventionAncestorId":"D000004791", "InterventionAncestorTerm":"Enzyme Inhibitors" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M398", "InterventionBrowseLeafName":"Erlotinib Hydrochloride", "InterventionBrowseLeafAsFound":"Erlotinib", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M24407", "InterventionBrowseLeafName":"Protein Kinase Inhibitors", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"ANeo", "InterventionBrowseBranchName":"Antineoplastic Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000002289", "ConditionMeshTerm":"Carcinoma, Non-Small-Cell Lung" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000002283", "ConditionAncestorTerm":"Carcinoma, Bronchogenic" },{ "ConditionAncestorId":"D000001984", "ConditionAncestorTerm":"Bronchial Neoplasms" },{ "ConditionAncestorId":"D000008175", "ConditionAncestorTerm":"Lung Neoplasms" },{ "ConditionAncestorId":"D000012142", "ConditionAncestorTerm":"Respiratory Tract Neoplasms" },{ "ConditionAncestorId":"D000013899", "ConditionAncestorTerm":"Thoracic Neoplasms" },{ "ConditionAncestorId":"D000009371", "ConditionAncestorTerm":"Neoplasms by Site" },{ "ConditionAncestorId":"D000009369", "ConditionAncestorTerm":"Neoplasms" },{ "ConditionAncestorId":"D000008171", "ConditionAncestorTerm":"Lung Diseases" },{ "ConditionAncestorId":"D000012140", "ConditionAncestorTerm":"Respiratory Tract Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M10890", "ConditionBrowseLeafName":"Neoplasm Metastasis", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9755", "ConditionBrowseLeafName":"Lung Neoplasms", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4128", "ConditionBrowseLeafName":"Carcinoma, Non-Small-Cell Lung", "ConditionBrowseLeafAsFound":"Non-Small Cell Lung Cancer", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M4116", "ConditionBrowseLeafName":"Carcinoma", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4122", "ConditionBrowseLeafName":"Carcinoma, Bronchogenic", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3842", "ConditionBrowseLeafName":"Bronchial Neoplasms", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13562", "ConditionBrowseLeafName":"Respiratory Tract Neoplasms", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M15241", "ConditionBrowseLeafName":"Thoracic Neoplasms", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9751", "ConditionBrowseLeafName":"Lung Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13560", "ConditionBrowseLeafName":"Respiratory Tract 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" } ] } } } } } }