[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603705":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":42,"responsibleParty":64,"collaborators":25,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":25,"enrollmentInfo":77,"targetDuration":25,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":25,"overallStatus":45,"whyStopped":25,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"University of Texas Southwestern Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"COHORT A (ES-SCLC PULSAR Thoracic Tumor):","EXPERIMENTAL","PULSAR with online adaptive planning to 7-10 Gy per fraction for up to 3 pulses directed at the bulkiest sites of disease in the thorax before infusion days (window: D-1 to D-4; optimal D-1) of three cycles of chemoimmunotherapy. The first radiotherapy pulse must be delivered before chemoimmunotherapy cycle 4. The three \"pulses\" of radiotherapy ideally should be given with consecutive cycles of systemic therapy. Radiotherapy can be suspended if a complete clinical response is reached before all 3 pulses are delivered. Chemoimmunotherapy will be given per standard of care",[13],"Radiation: Cohort A: Extensive Stage Small Cell Lung Cancer (ES-SCLC) Thoracic Tumor PULSAR (Personalized ultrahypofractionated stereotactic ablative radiotherapy)",{"label":15,"type":10,"description":16,"interventionNames":17},"COHORT B (Brain metastasis PULSAR):","PULSAR will be delivered in a 2 \"pulse\" strategy:\n\n1: Deliver fSRT\u002FSRS every other day (minimum 48 hour separation between treatments, minimum 1 treatment per week;begin and complete within 60 days of registration) for 3 fractions. Pulse 1 must begin and complete within 60 days of registration; 2) Repeat treatment planning MRI will be performed after 4 weeks (window: +\u002F-1 weeks) after fraction 3 and volumetric response assessment made; 3) Pulse 2 is omitted in those with \\>=25% volumetric size reduction response. In others, pulse 2 will deliver fSRT\u002FSRS every other day (minimum 48 hour separation between treatments, minimum 1 treatment per week). Pulse 2 may deliver higher dose per fraction within Section 4.1.3.4 specifications (Table 6), rationale for this would be for addressing lesions that either due to large size or proximity to critical structures could only be treated to a lower dose range in pulse 1. Pulse 2 must begin 4 weeks (+\u002F-1 weeks) after end of Pulse 1.",[18],"Radiation: Cohort B: Brain metastasis PULSAR (Personalized ultrahypofractionated stereotactic ablative radiotherapy)",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"RADIATION","Cohort A: Extensive Stage Small Cell Lung Cancer (ES-SCLC) Thoracic Tumor PULSAR (Personalized ultrahypofractionated stereotactic ablative radiotherapy)","Radiographic response-adapted thoracic tumor radiotherapy given as single doses ('pulses') before standard of care chemoimmunotherapy cycles. Adaptive Changes Allowed: Tumor target (size\u002Fshape), # of doses (reduction) Adaptive Changes Allowed: Tumor target (size\u002Fshape), # of doses (reduction)",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Cohort B: Brain metastasis PULSAR (Personalized ultrahypofractionated stereotactic ablative radiotherapy)","Intervention: Fractionated stereotactic radiosurgery (SRS, 5 doses total) for brain metastasis given in two \"pulses\" (3 fractions + 2 fractions) with second pulse adapted to interim radiographic response Adaptive Changes Allowed: Omission of 2nd \"pulse\" in \\>=25% responders or tumor target size\u002Fshape change in remainder",[15],[31],{"name":32,"affiliation":5,"role":33},"NEIL DESAI, MD, MHS","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"SARAH NEUFELD","CONTACT","214 648 1836","Sarah.Hardee@UTSouthwestern.edu",{"name":32,"role":37,"phone":38,"phoneExt":25,"email":41},"Neil.Desai@UTSouthwestern.edu",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Ut Southwestern Medical Center","RECRUITING","Dallas","Texas","75390","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-96.80667,32.78306,{"lat":55,"lon":54},[58,61],{"name":36,"role":37,"phone":59,"phoneExt":25,"email":60},"214-648-1836","SARAH.HARDEE@UTSOUTHWESTERN.EDU",{"name":62,"role":37,"phone":38,"phoneExt":25,"email":63},"NEIL DESAI, MD","neil.desai@utsouthwestern.edu",{"type":33,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Neil Desai","Principal Investigator, MD MHS","100603705","phase-1-personalized-radiotherapy-for-individualized-treatment-strategies-and-monitoring-prism-100603705",false,"NCT07139990","Personalized Radiotherapy for Individualized Treatment Strategies and Monitoring (PRISM)","Personalized Radiotherapy for Individualized Treatment Strategies and Monitoring (PRISM): A Multi-cohort Platform Trial of Adaptive Radiotherapy Approaches in Multiple Cancer Types","PRISM","Inclusion Criteria:\n\nCohort A:\n\n* \\>=18 years old\n* Performance status ECOG 0-2\n* Extensive stage small cell lung cancer diagnosed by tissue biopsy within 180 days of registration.\n* Patient must be planned for or receiving standard of care chemoimmunotherapy.\n* Patient must have received no more than 3 cycles by time of study enrollment.\n* Able and indicated according to investigator to receive thoracic radiotherapy\n\nCohort B:\n\n* 18 years old\n* Diagnosis of solid tumor malignancy with MRI-defined brain metastasis lesions (1-5 lesions allowed) within 60 days of registration\n* Each brain metastasis lesion enrolled must be 2 - 5 cm, except brainstem lesions which may be 1.5 - 5cm in size.\n\nExclusion Criteria:\n\nCohort A:\n\n⨀ Prior thoracic Radiotherapy\n\nCohort B:\n\n* Prior whole brain Radiotherapy\n* Prior surgical resection or focal radiotherapy of a target brain metastasis\n* Leptomeningeal disease","ALL","18 Years",{"count":78,"type":79},45,"ESTIMATED","INTERVENTIONAL",[82],"PHASE1","To characterize feasibility, safety, and\u002For preliminary efficacy of personalized strategies to adapt standard radiotherapy treatments to individual patient responses.",[85,86,87],"Small Cell Lung Cancer Extensive Stage","Brain Metastases","Solid Tumor, Adult","2025-11-06",{"date":90,"type":91},"2025-11-10","ACTUAL",{"date":93,"type":91},"2025-10-28",{"date":95,"type":79},"2030-09-01",{"name":5,"class":6},1]