[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100457465":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":32,"locations":39,"responsibleParty":58,"collaborators":26,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":26,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":41,"whyStopped":26,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Tata Memorial Hospital","OTHER_GOV",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Upfront Cranial Radiotherapy","ACTIVE_COMPARATOR","Stereotactic radiosurgery or Whole brain radiotherapy upfront in asymptomatic brain metastases",[13,14],"Radiation: Stereotactic radiosurgery\u002Fwhole brain radiotherapy","Drug: Tyrosine kinase inhibitor",{"label":16,"type":17,"description":18,"interventionNames":19},"Observation (Delayed Cranial Radiotherapy)","EXPERIMENTAL","Observation (Delayed Cranial radiotherapy) of Asymptomatic brain metastases",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"RADIATION","Stereotactic radiosurgery\u002Fwhole brain radiotherapy","SRS\u002F WBRT for asymptomatic brain metastases depending on the number of brain metastases",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DRUG","Tyrosine kinase inhibitor","TKI",[16,9],[33],{"name":34,"role":35,"phone":36,"phoneExt":37,"email":38},"Anil Tibdewal, MD","CONTACT","9122 2417 7000","7030","aniltibdewal@gmail.com",[40],{"facility":5,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Mumbai","Maharashtra","400012","India","IN",{"type":48,"coordinates":49},"Point",[50,51],72.88261,19.07283,{"lat":51,"lon":50},[54,56],{"name":55,"role":35,"phone":26,"phoneExt":26,"email":38},"Dr. Anil Tibdewal, MD",{"name":55,"role":57,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"type":57,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Anil Tibdewal","Dr. Anil Tibdewal, Associate Professor, Radiation Oncology","100457465","phase-3-observation-or-upfront-cranial-rt-in-oncogene-mutated-nsclc-with-asymptomatic-bm-a-phase-iii-rct-100457465",false,"NCT05236946","Observation or Upfront Cranial RT in Oncogene Mutated NSCLC With Asymptomatic BM: A Phase III RCT","Observation or Upfront Cranial RT in Oncogene Driver Mutated NSCLC With Asymptomatic Brain Metastases: A Phase III Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Patients with ECOG performance status of 0-2\n3. Patients with pathologically proven diagnosis of NSCLC\n4. Patients with positive oncogene mutation status (EGFR\u002FALK)\n5. Patients with radiologically confirmed parenchymal brain metastases\n6. Patients with asymptomatic Synchronous or Metachronous brain metastases\n7. Patients willing for written informed consent and must be willing to comply with the specified follow-up schedule\n\nExclusion Criteria:\n\n1. Patients with CSF dissemination only without any parenchymal brain metastases\n2. Patients with brain metastases in the brain stem\n3. Patients with prior history of radiation therapy to the brain\n4. Patient not suitable for TKI therapy as per the medical oncologist\n5. Pregnant or lactating females","ALL","18 Years","99 Years",{"count":72,"type":73},190,"ESTIMATED","INTERVENTIONAL",[76],"PHASE3","Tyrosine Kinase Inhibitors (TKIs) especially higher generation TKI have higher CNS penetration rates and have shown favorable response rates in brain metastases. Brain radiotherapy\u002Fsurgery is the standard treatment in brain metastases especially symptomatic metastases, however, the role of local treatment especially in driver mutation-positive non-small cell lung cancer with asymptomatic brain metastases is being questioned given their potential side effects. No randomized trial has shown the superiority of early vs delayed cranial RT in asymptomatic BM of driver mutated NSCLC.",[79,80],"Asymptomatic Brain Metastases","Driver Mutation Positive Non-small Cell Lung Cancer",[82,83,84,85,86],"Asymptomatic brain metastases","EGFR mutation","Whole brain radiotherapy","Stereotactic radiosurgery","ALK rearrangement","2025-09-03",{"date":89,"type":90},"2025-09-10","ACTUAL",{"date":92,"type":90},"2020-11-10",{"date":94,"type":73},"2026-12",{"name":5,"class":6},1]