[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603705":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":48,"centralContacts":52,"locations":60,"responsibleParty":82,"collaborators":35,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":87,"sex":93,"minAge":94,"maxAge":35,"enrollmentInfo":95,"targetDuration":35,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":35,"overallStatus":63,"whyStopped":35,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"University of Texas Southwestern Medical Center","OTHER",[8,14,19,24],{"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)",{"label":20,"type":10,"description":21,"interventionNames":22},"COHORT C (Sarcoma Pre-operative PULSAR)","Patients will receive pembrolizumab infusion every 3 weeks for three doses starting the day after the first pulse of radiation and then synchronizing the day after the administration of each pulse of radiation. Adjuvant pembrolizumab may be given at physician discretion per standard of care. External beam radiation will be delivered to a dose of 24 Gy in pulses of 8 Gy each once every 3 weeks over a total of 9 weeks. Surgery will be performed 3-6 weeks after cycle 3 of immunotherapy.",[23],"Radiation: Cohort C: Sarcoma Pre-Operative PULSAR",{"label":25,"type":10,"description":26,"interventionNames":27},"COHORT D (Resectable HNSCC PULSAR\u002FSAbR):","Random PULSAR or SAbR,by site.PULSAR:Each pulse of radiotherapy(RT)(8Gy)given to primary tumor\u002Finvolved nodes using online adaptive RT plan.RT given 1-7 days before each pembrolizumab cycle,total of 3 pulses,3 weeks apart.Before 3rd pulse,repeat MRI \\& PET simulation done.SAbR:Each fraction of RT(8 Gy)given to primary tumor\u002Fnodes using online adaptive RT plan.Total of 3 fractions of RT over 2 weeks,then 3 cycles of pembrolizumab done every 3 weeks.Both arms:adjuvant RT determined on surgical pathology \\& risks of recurrence.Factors in primary tumor for adjuvant RT:pathologic T3\u002FT4,positive\u002Fclose(defined as \\\u003C3 mm)margins,lymphovascular invasion\u002Fperineural invasion.Factors in neck for adjuvant RT: \\>1 lymph node,lymph nodes \\>3 cm. Independent decision to treat primary site\u002Flymph(either primary site\u002Flymph treated based on criteria.)For adjuvant RT,primary site dose:60Gy in 30 fractions.Involved nodals:60Gy in 30 fractions.Uninvolved nodals:54Gy in 30 fractions.",[28],"Radiation: Cohort D: Resectable Head & Neck Squamous Cell Carcinoma (HNSCC) PULSAR\u002FSAbR",[30,36,40,44],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"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":31,"name":37,"description":38,"armGroupLabels":39,"otherNames":35},"Cohort B: Brain metastasis PULSAR (Personalized ultrahypofractionated stereotactic ablative radiotherapy)","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],{"type":31,"name":41,"description":42,"armGroupLabels":43,"otherNames":35},"Cohort C: Sarcoma Pre-Operative PULSAR","Pre-operative PULSAR with immunotherapy for localized soft tissue sarcoma Adaptive Changes Allowed: Tumor target (size\u002Fshape)",[20],{"type":31,"name":45,"description":46,"armGroupLabels":47,"otherNames":35},"Cohort D: Resectable Head & Neck Squamous Cell Carcinoma (HNSCC) PULSAR\u002FSAbR","Neoadjuvant immunotherapy \\& radiation given as either PULSAR (3 \"pulses\") or SAbR (3 fractions) prior to resection for HNSCC Adaptive Changes Allowed: Tumor and nodal target (size\u002Fshape)",[25],[49],{"name":50,"affiliation":5,"role":51},"NEIL DESAI, MD, MHS","PRINCIPAL_INVESTIGATOR",[53,58],{"name":54,"role":55,"phone":56,"phoneExt":35,"email":57},"SARAH NEUFELD","CONTACT","214 648 1836","Sarah.Hardee@UTSouthwestern.edu",{"name":50,"role":55,"phone":56,"phoneExt":35,"email":59},"Neil.Desai@UTSouthwestern.edu",[61],{"facility":62,"status":63,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Ut Southwestern Medical Center","RECRUITING","Dallas","Texas","75390","United States","US",{"type":70,"coordinates":71},"Point",[72,73],-96.80667,32.78306,{"lat":73,"lon":72},[76,79],{"name":54,"role":55,"phone":77,"phoneExt":35,"email":78},"214-648-1836","SARAH.HARDEE@UTSOUTHWESTERN.EDU",{"name":80,"role":55,"phone":56,"phoneExt":35,"email":81},"NEIL DESAI, MD","neil.desai@utsouthwestern.edu",{"type":51,"investigatorFullName":83,"investigatorTitle":84,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"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 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\nCohort C:\n\n* \\>=18 years old\n* Performance status ECOG 0-2\n* Histologically confirmed surgically resectable, high grade (FNCLCC grade 2 or 3), localized soft tissue sarcoma of the trunk or extremities that measures \\>5 cm in any direction as assessed by imaging\n* Eligible to receive immunotherapy\n\nCohort D:\n\n* \\>=18 years old\n* Performance status ECOG 0-2\n* Pathologically proven diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx\n* Clinical stage III\u002FIVA (AJCC 8th edition)\n* Disease must be deemed resectable by head and neck surgeon\n* Eligible to receive immunotherapy\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\n\nCohort C:\n\n* Unresectable or metastatic (nodal or distant) disease\n* Synchronous malignancy requiring chemotherapy or other intensive treatment\n* Locally recurrent soft tissue sarcoma\n* Prior immunotherapy\n* Pregnancy or breastfeeding\n\nCohort D:\n\n* Distant metastasis\n* Inability to undergo PET-CT for baseline staging\n* HPV-positive or p16-positive oropharyngeal cancer\n* Prior systemic chemotherapy for the study cancer; prior chemotherapy for a remote cancer is allowable\n* Prior immunotherapy for the study cancer or for a remote cancer\n* Prior head and neck radiotherapy","ALL","18 Years",{"count":96,"type":97},105,"ESTIMATED","INTERVENTIONAL",[100],"PHASE1","To characterize feasibility, safety, and\u002For preliminary efficacy of personalized strategies to adapt standard radiotherapy treatments to individual patient responses.",[103,104,105,106,107,108],"Small Cell Lung Cancer Extensive Stage","Brain Metastases","Solid Tumor, Adult","Thoracic Cancer","Sarcoma,Soft Tissue","HNPCC","2026-08-12",{"date":111,"type":112},"2026-08-17","ACTUAL",{"date":114,"type":112},"2025-10-28",{"date":116,"type":97},"2032-09-01",{"name":5,"class":6},1]