[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05419076":3,"trial-entities:NCT05419076":163,"trial-summary:NCT05419076":168},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":24,"study_type":31,"primary_purpose":32,"phases":33,"enrollment_info":35,"interventions":38,"primary_outcomes":53,"secondary_outcomes":58,"sex":59,"minimum_age":60,"maximum_age":15,"healthy_volunteers":61,"eligibility_criteria":62,"std_ages":77,"locations":80,"central_contacts":149,"overall_officials":156,"references":159,"see_also_links":160},"NCT05419076","22-133","A Study of Stereotactic Radiosurgery (SRS) for People With Lung Cancer That Has Spread to the Brain","A Single Arm Phase II Study Assessing Efficacy of Stereotactic Radiosurgery (SRS) for Brain Metastasis (BM) From Small Cell Lung Cancer (SCLC)","RECRUITING","2027-06-10","2026-06","2026-06-10","2022-06-10","Memorial Sloan Kettering Cancer Center","OTHER",null,"The purpose of the study is to see if stereotactic radiosurgery\u002FSRS is an effective treatment for people with a new diagnosis of brain metastases from small cell lung cancer\u002FSCLC.",[18,19,20,21,22,23],"Lung Cancer","Lung Cancer Metastatic","Brain Metastases","Brain Metastases, Adult","Small-cell Lung Cancer","Small Cell Lung Carcinoma",[25,26,27,28,29,30,5,13],"Stereotactic Radiosurgery","small cell lung cancer","small cell lung carcinoma","lung cancer","lung cancer metastatic","brain metastases","INTERVENTIONAL","TREATMENT",[34],"PHASE2",{"count":36,"type":37},62,"ESTIMATED",[39,46],{"type":40,"name":25,"description":41,"armGroupLabels":42,"otherNames":44},"RADIATION","All participants will undergo MSK standard SRS. A CT simulation will be performed per institutional standards, typically with contrast unless a contraindication exists. A contrast-enhanced MRI with 1mm slices will be fused to the CT simulation scan for the purposes of SRS planning. The SRS GTV will be considered the visible tumor on MRI and CT contrast enhanced studies. An expansion of 1-2mm will be used to create the PTV. Radiation dose may be between 16Gy and 30Gy in 1 to 5 fractions, per the discretion of the treating radiation oncologist. Participants with multiple lesions may receive different doses to each lesion per the discretion of the treating radiation oncologist. Concurrent treatment to other body sites is permitted.",[43],"Participants with small cell lung cancer with brain metastases",[45],"SRS",{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"PROCEDURE","Cerebrospinal fluid collection","All participants will undergo lumbar puncture for CSF collection at study enrollment.. Lumbar punctures will be performed by clinical staff in neurology or neuroradiology, per the discretion of the treating radiation oncologist, as dictated by scheduling limitations and expected clinical difficulty in obtaining a sample (e.g. requiring fluoroscopic guidance), with input from the PI, neurology, and\u002For neuroradiology as necessary. Participants will be encouraged to undergo repeat lumbar puncture for CSF collection at 3 months (+\u002F- 4 weeks), and at the time of CNS disease progression, though these latter timepoints are not required. CSF cytology will be evaluated.",[43],[52],"CSF",[54],{"measure":55,"description":56,"timeFrame":57},"Overall survival","The primary endpoint of this study is the rate of overall survival at 6 months, with time measured from the start of SRS treatment. Participants will be censored at the date of last follow up or the last date the participant was known to be alive.","6 months",[],"ALL","18 Years",false,{"inclusion":63,"exclusion":70,"raw_text":76},[64,65,66,67,68,69],"Histologic diagnosis of small cell lung cancer","Radiographic diagnosis of up to 20 brain metastases on contrast-enhanced MRI","Age 18 and above","Performance status KPS 60-100\u002FECOG 0-2","Female patients must be of non-reproductive potential or have a negative serum pregnancy test at the time of enrollment","The patient or legally authorized representative is able to provide informed consent",[71,72,73,74,75],"Unable to undergo contrast-enhanced MRI brain","Leptomeningeal disease confirmed on lumbar puncture, MRI brain, or MRI spine","Pregnant or lactating women","Prior brain-directed radiotherapy","Uncontrolled systemic disease without reasonable systemic therapy options felt likely to result in death as observed on CT or PET\u002FCT imaging, no more than 3 months before study enrollment","Inclusion Criteria:\n\n* Histologic diagnosis of small cell lung cancer\n* Radiographic diagnosis of up to 20 brain metastases on contrast-enhanced MRI\n* Age 18 and above\n* Performance status KPS 60-100\u002FECOG 0-2\n* Female patients must be of non-reproductive potential or have a negative serum pregnancy test at the time of enrollment\n* The patient or legally authorized representative is able to provide informed consent\n\nExclusion Criteria:\n\n* Unable to undergo contrast-enhanced MRI brain\n* Leptomeningeal disease confirmed on lumbar puncture, MRI brain, or MRI spine\n* Pregnant or lactating women\n* Prior brain-directed radiotherapy\n* Uncontrolled systemic disease without reasonable systemic therapy options felt likely to result in death as observed on CT or PET\u002FCT imaging, no more than 3 months before study enrollment",[78,79],"ADULT","OLDER_ADULT",[81,95,104,113,123,132,140],{"facility":82,"status":8,"city":83,"state":84,"zip":85,"country":86,"contacts":87,"geoPoint":92},"Memorial Sloan Kettering at Basking Ridge","Basking Ridge","New Jersey","07920","United States",[88],{"name":89,"role":90,"phone":91},"Luke Pike, MD","CONTACT","201-775-7604",{"lat":93,"lon":94},40.70621,-74.54932,{"facility":96,"status":8,"city":97,"state":84,"zip":98,"country":86,"contacts":99,"geoPoint":101},"Memorial Sloan Kettering Monmouth","Middletown","07748",[100],{"name":89,"role":90,"phone":91},{"lat":102,"lon":103},40.39428,-74.11709,{"facility":105,"status":8,"city":106,"state":84,"zip":107,"country":86,"contacts":108,"geoPoint":110},"Memorial Sloan Kettering Bergen","Montvale","07645",[109],{"name":89,"role":90,"phone":91},{"lat":111,"lon":112},41.04676,-74.02292,{"facility":114,"status":8,"city":115,"state":116,"zip":117,"country":86,"contacts":118,"geoPoint":120},"Memorial Sloan Kettering Suffolk - Commack","Commack","New York","11725",[119],{"name":89,"role":90,"phone":91},{"lat":121,"lon":122},40.84288,-73.29289,{"facility":124,"status":8,"city":125,"state":116,"zip":126,"country":86,"contacts":127,"geoPoint":129},"Memorial Sloan Kettering Westchester","Harrison","10604",[128],{"name":89,"role":90,"phone":91},{"lat":130,"lon":131},40.96899,-73.71263,{"facility":133,"status":8,"city":116,"state":116,"zip":134,"country":86,"contacts":135,"geoPoint":137},"Memorial Sloan Kettering Cancer Center (All Protocol Activities)","10065",[136],{"name":89,"role":90,"phone":91},{"lat":138,"lon":139},40.71427,-74.00597,{"facility":141,"status":8,"city":142,"state":116,"zip":143,"country":86,"contacts":144,"geoPoint":146},"Memorial Sloan Kettering Nassau","Rockville Centre","11553",[145],{"name":89,"role":90,"phone":91},{"lat":147,"lon":148},40.65871,-73.64124,[150,152],{"name":89,"role":90,"phone":91,"email":151},"PikeL@mskcc.org",{"name":153,"role":90,"phone":154,"email":155},"Brandon Imber, MD","631-212-6346","imberb@mskcc.org",[157],{"name":89,"affiliation":13,"role":158},"PRINCIPAL_INVESTIGATOR",[],[161],{"label":13,"url":162},"http:\u002F\u002Fwww.mskcc.org",{"nct_id":4,"conditions":164,"biomarkers":167},[165,166],"Lung Small Cell Carcinoma","Metastatic Malignant Neoplasm in the Brain",[],{"nct_id":4,"found":169,"summary":170,"prompt_version":180},true,{"design":171,"status":172,"heading":173,"summary":174,"follow_up":175,"word_count":176,"commitments":177,"compensation":178,"drugs_mentioned":179},"This is an interventional study with a planned enrollment of 62 participants. It is a single-arm study, meaning all participants receive the same treatment.","completed","Stereotactic Radiosurgery for Lung Cancer That Has Spread to the Brain","This study is looking at Stereotactic Radiosurgery (SRS) to treat people with small cell lung cancer that has spread to the brain (brain metastases). SRS is a type of radiation treatment. To join, you must have a diagnosis of small cell lung cancer, up to 20 brain metastases, be 18 or older, and have a good performance status (meaning you can do most daily activities). All participants will receive standard SRS treatment and will also have a lumbar puncture (spinal tap) to collect cerebrospinal fluid. The main goal is to see how long people live after treatment, measured at 6 months. The current recruitment status is unclear.","The study measures overall survival at 6 months after treatment.",107,"You would undergo a CT simulation and an MRI for treatment planning, followed by Stereotactic Radiosurgery. You would also have a lumbar puncture (spinal tap) at the start of the study.","Not stated in the trial record.",[25],"v2"]