Nctid:
NCT06611657
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-02"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000055752", "term"=>"Small Cell Lung Carcinoma"}, {"id"=>"D000001932", "term"=>"Brain Neoplasms"}], "ancestors"=>[{"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000002283", "term"=>"Carcinoma, Bronchogenic"}, {"id"=>"D000001984", "term"=>"Bronchial Neoplasms"}, {"id"=>"D000008175", "term"=>"Lung Neoplasms"}, {"id"=>"D000012142", "term"=>"Respiratory Tract Neoplasms"}, {"id"=>"D000013899", "term"=>"Thoracic Neoplasms"}, {"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000008171", "term"=>"Lung Diseases"}, {"id"=>"D000012140", "term"=>"Respiratory Tract Diseases"}, {"id"=>"D000016543", "term"=>"Central Nervous System Neoplasms"}, {"id"=>"D000009423", "term"=>"Nervous System Neoplasms"}, {"id"=>"D000001927", "term"=>"Brain Diseases"}, {"id"=>"D000002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}], "browseLeaves"=>[{"id"=>"M11172", "name"=>"Lung Neoplasms", "relevance"=>"LOW"}, {"id"=>"M12307", "name"=>"Neoplasm Metastasis", "relevance"=>"LOW"}, {"id"=>"M28323", "name"=>"Small Cell Lung Carcinoma", "asFound"=>"Small Cell Lung Cancer", "relevance"=>"HIGH"}, {"id"=>"M5534", "name"=>"Carcinoma", "relevance"=>"LOW"}, {"id"=>"M5209", "name"=>"Brain Neoplasms", "asFound"=>"Brain Metastases", "relevance"=>"HIGH"}, {"id"=>"M5540", "name"=>"Carcinoma, Bronchogenic", "relevance"=>"LOW"}, {"id"=>"M5260", "name"=>"Bronchial Neoplasms", "relevance"=>"LOW"}, {"id"=>"M14979", "name"=>"Respiratory Tract Neoplasms", "relevance"=>"LOW"}, {"id"=>"M16658", "name"=>"Thoracic Neoplasms", "relevance"=>"LOW"}, {"id"=>"M11168", "name"=>"Lung Diseases", "relevance"=>"LOW"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "relevance"=>"LOW"}, {"id"=>"M12367", "name"=>"Nervous System Neoplasms", "relevance"=>"LOW"}, {"id"=>"M18937", "name"=>"Central Nervous System Neoplasms", "relevance"=>"LOW"}, {"id"=>"M5204", "name"=>"Brain Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"T5271", "name"=>"Small Cell Lung Cancer", "asFound"=>"Small Cell Lung Cancer", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>40}}, "statusModule"=>{"overallStatus"=>"ACTIVE_NOT_RECRUITING", "startDateStruct"=>{"date"=>"2021-08-20", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-08", "completionDateStruct"=>{"date"=>"2025-07-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-22", "studyFirstSubmitDate"=>"2024-09-22", "studyFirstSubmitQcDate"=>"2024-09-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-06-10", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Intracranial progression-free survival", "timeFrame"=>"6 months", "description"=>"Time from enrollment to intracranial tumor progression or death"}], "secondaryOutcomes"=>[{"measure"=>"Overall Survival", "timeFrame"=>"1 year", "description"=>"The time from enrollment to death from any cause was calculated as the time of death. For participants who were lost to follow-up, the time of death was usually the time of the last follow-up."}, {"measure"=>"progression-free survival", "timeFrame"=>"6 months", "description"=>"The time from enrollment to tumor progression (any aspect) or death from any cause"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Whole Brain Radiotherapy"]}, "descriptionModule"=>{"briefSummary"=>"The objective of this study was to evaluate the efficacy and safety of whole brain radiotherapy combined with antirotinib hydrochloride in the treatment of brain metastases in small cell lung cancer", "detailedDescription"=>"This was a single-center, single-arm trail. Enrolled patients were pathologically diagnosed with small cell lung cancer and had completed at least 4 cycles of first-line chemotherapy. Patients with brain metastases at first visit or during treatment were treated with whole brain radiotherapy combined with anlotinib hydrochloride. Oral antirotinib was started 2 weeks before radiotherapy for brain metastases and stopped for 1 week after 2 weeks. After radiotherapy, antirotinib was continued until tumor progression. Efficacy and toxicity data were collected for evaluation and analysis."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"80 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Small cell lung cancer confirmed by pathology, completion of at least 4 cycles of first-line chemotherapy, and measurable disease according to RECIST criteria.\n2. The expected survival time is more than 3 months.\n3. Intracranial metastases ≤10.\n4. Adequate organ and bone marrow function.\n\nExclusion Criteria:\n\n1. Patients who have used antiangiogenic drugs within the previous 1 month.\n2. Non-small cell lung cancer (including small cell carcinoma and non-small cell carcinoma mixed lung cancer).\n3. Small cell lung cancer with hilar invasion or hemoptysis.\n4. Patients with intracranial acute, subacute cerebral infarction, intracranial lesions acute, subacute hemorrhage.\n5. An unresolved acute toxic reaction period higher than grade 2 of CTC-AE(4.0) due to any prior treatment.\n6. Advanced patients with severe symptoms, tumors that have spread to the internal organs, and a short-term risk of life-threatening complications.\n7. Patients with life-threatening conditions of other severe and/or uncontrolled diseases."}, "identificationModule"=>{"nctId"=>"NCT06611657", "briefTitle"=>"Antirotinib Hydrochloride Plus Whole Brain Radiotherapy for Small Cell Lung Cancer With Brain Metastases", "organization"=>{"class"=>"OTHER", "fullName"=>"Cancer Institute and Hospital, Chinese Academy of Medical Sciences"}, "officialTitle"=>"Anlotinib Hydrochloride Combined With Whole Brain Radiotherapy for the Treatment of Brain Metastases in Small Cell Lung Cancer", "orgStudyIdInfo"=>{"id"=>"NCC2766"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Anlotinib hydrochloride + whole brain radiotherapy", "description"=>"Take antirotinib hydrochloride capsules on an empty stomach at breakfast, 1 capsule (12mg) once a day. The treatment was started 1 week before radiotherapy positioning, and was stopped for 1 week for 2 consecutive weeks. The treatment cycle was 3 weeks. After radiotherapy, antirotinib was continued until tumor progression.", "interventionNames"=>["Drug: Antirotinib hydrochloride"]}], "interventions"=>[{"name"=>"Antirotinib hydrochloride", "type"=>"DRUG", "otherNames"=>["whole brain radiotherapy combined with anlotinib hydrochloride"], "description"=>"Oral antirotinib treatment was started 2 weeks before radiotherapy for brain metastases, stopped for 1 week after 2 weeks, and continued after radiotherapy until tumor progression", "armGroupLabels"=>["Anlotinib hydrochloride + whole brain radiotherapy"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"100021", "city"=>"Beijing", "state"=>"Beijing", "country"=>"China", "facility"=>"Cancer Hospital Chinese Academy of Medical Sciences", "geoPoint"=>{"lat"=>39.9075, "lon"=>116.39723}}], "overallOfficials"=>[{"name"=>"Lei Deng, MD", "role"=>"STUDY_CHAIR", "affiliation"=>"Cancer Institute and Hospital, Chinese Academy of Medical Sciences"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Cancer Institute and Hospital, Chinese Academy of Medical Sciences", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
