[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100266402":3},{"organization":4,"outcomesModule":7,"designInfo":47,"detailedDescription":46,"studyPopulation":46,"armGroups":53,"interventions":63,"overallOfficials":69,"centralContacts":73,"locations":79,"responsibleParty":97,"collaborators":46,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":46,"eligibilityCriteria":105,"healthyVolunteers":101,"sex":106,"minAge":107,"maxAge":46,"enrollmentInfo":108,"targetDuration":46,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":81,"whyStopped":46,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"University of Chicago","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":46},[9],{"measure":10,"description":11,"timeFrame":12},"Progression free survival (PFS) rates estimated by the Kaplan-Meier method at 6 months","Progression free survival (PFS) rates will be estimated by the Kaplan-Meier method and the 0-mm and 2-mm groups will be compared via the log-rank statistic with a one-sided test of significance, using follow-up data up to 6 months.","6 months",[14,18,21,24,27,30,34,37,40,43],{"measure":15,"description":16,"timeFrame":17},"Progression free survival (PFS) rates estimated by the Kaplan-Meier method","Progression free survival (PFS) rates will be estimated by the Kaplan-Meier method and the 0-mm, and 2-mm groups will be compared via the log-rank statistic with a one-sided test of significance, using follow-up data up to 6 months.","2 years",{"measure":19,"description":20,"timeFrame":17},"Overall survival rates","Time from Stereotactic Radiosurgery (SRS) completion to death.",{"measure":22,"description":23,"timeFrame":17},"Rates of radiation necrosis","To evaluate the superiority of frameless LINAC-based SRS using 0 mm margins compared to 2 mm margins in reducing rates of radiation necrosis.",{"measure":25,"description":26,"timeFrame":17},"Rates of pseudoprogression","To evaluate the superiority of frameless LINAC-based SRS using 0 mm margins compared to 2 mm margins in reducing rates of radiation pseudoprogression.",{"measure":28,"description":29,"timeFrame":17},"Local failure rates","Local failure and OS rates at 6 months, 1 year and 2 years will be estimated by the Kaplan-Meier method, comparing arms via the log-rank statistic.",{"measure":31,"description":32,"timeFrame":33},"Rate of acute central nervous system (CNS) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grade 2 and higher toxicities","Any acute CTCAE v4.0 CNS Grade 2+ and Grade 3+ toxicities, within 90 days of SRS completion (toxicity must be specified).","90 days",{"measure":35,"description":36,"timeFrame":17},"Rate of late central nervous system (CNS) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grade 2 and higher toxicities","To compare rates of late (greater than 90 days from SRS) CTCAE v4.0 CNS Grade 2+ and Grade 3+ toxicities.",{"measure":38,"description":39,"timeFrame":17},"Rates of distant intracranial failure","The appearance of new non-target lesions ≥5 mm following completion of radiotherapy will be considered distant intracranial failure. If a non-target lesion \\\u003C5 mm is found on a later scan to have increased to ≥ 5 mm, distant intracranial failure will be declared at the date of the earliest scan showing the new lesion.",{"measure":41,"description":42,"timeFrame":17},"Rates of salvage therapy","Time to initiation of any combination of salvage Stereotactic Radiosurgery (SRS), Whole Brain Radiation Therapy WBRT, or neurosurgical resection for intracranial failure.",{"measure":44,"description":45,"timeFrame":17},"Association between dose and risk of radionecrosis or pseudoprogression","To determine association between V10Gy and V12Gy all tissue, whole brain and normal brain parameters and risk of radionecrosis or pseudoprogression.",null,{"allocation":48,"interventionModel":49,"interventionModelDescription":46,"primaryPurpose":50,"observationalModel":46,"timePerspective":46,"maskingInfo":51},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":52,"maskingDescription":46,"whoMasked":46},"NONE",[54,59],{"label":55,"type":56,"description":46,"interventionNames":57},"Stereotactic Radiosurgery to 2 mm GTV to PTV margins","ACTIVE_COMPARATOR",[58],"Procedure: Stereotactic Radiosurgery",{"label":60,"type":61,"description":46,"interventionNames":62},"Stereotactic Radiosurgery to 0 mm GTV to PTV margins","EXPERIMENTAL",[58],[64],{"type":65,"name":66,"description":67,"armGroupLabels":68,"otherNames":46},"PROCEDURE","Stereotactic Radiosurgery","The SRS dose will depend on the maximum diameter of the gross tumor volume (GTV)",[60,55],[70],{"name":71,"affiliation":5,"role":72},"Steven J. Chmura, M.D., Ph.D.","PRINCIPAL_INVESTIGATOR",[74],{"name":75,"role":76,"phone":77,"phoneExt":46,"email":78},"Robyn Hseu","CONTACT","773-834-3198","rhseu@radonc.uchicago.edu",[80],{"facility":5,"status":81,"city":82,"state":83,"zip":84,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":92,"contacts":93},"RECRUITING","Chicago","Illinois","60637","United States","US",{"type":88,"coordinates":89},"Point",[90,91],-87.65005,41.85003,{"lat":91,"lon":90},[94,95],{"name":75,"role":76,"phone":46,"phoneExt":46,"email":78},{"name":96,"role":72,"phone":46,"phoneExt":46,"email":46},"Aditya Juloori, M.D., Ph.D.",{"type":98,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR","100266402","phase-2-frameless-stereotactic-radiosurgery-for-intact-brain-metastases-100266402",false,"NCT02747303","Frameless Stereotactic Radiosurgery for Intact Brain Metastases","The Clinical Relevance of Margins in Frameless Stereotactic Radiosurgery for Intact Brain Metastases: a Randomized Trial of 0 vs 2 mm Margins","Inclusion Criteria:\n\n* Adult patients (≥ 18 years old) with an ECOG Performance Status 0-2 and a life expectancy of 3 months or more.\n* Histologically confirmed systemic malignancy with gadolinium contrast-enhanced MRI scan demonstrating 1-5 intraparenchymal brain metastases.\n* Well-circumscribed, measureable intraparenchymal brain lesion(s) with maximum tumor diameter ≤3.0 cm. If multiple lesions are present, the other(s) must not exceed 3.0 cm in maximum diameter. At least one lesion must be ≥1.0 cm in maximum diameter and ≥0.5 cm in a perpendicular diameter to be considered measurable disease.\n* Negative urine or serum pregnancy test done ≤ 14 days prior to CT simulation, for women of child-bearing potential only.\n* Ability to understand and willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Diagnosis of germ cell tumor, small cell carcinoma or hematologic malignancy.\n* Metastases in the brain stem, midbrain, pons, medulla, or within 7 mm of the optic apparatus (optic nerves, chiasm and optic tracts).\n* Diagnosis of leptomeningeal disease.\n* Prior cranial radiotherapy within 90 days of trial enrollment or prior SRS at any time to any lesion to be treated on protocol\n* Chemotherapy (including oral agents and targeted agents) or immunotherapy given within 14 days of SRS. Hormonal therapy is permitted. For Her2+ breast cancer patients, anti-Her2 therapy cannot be given within 14 days of SRS. Patients who are scheduled to receive trastuzumab emtansine after SRS cannot be enrolled.\n* Contraindications to gadolinium contrast-enhanced MRI (eg, non-compatible pacemaker, eGFR\\\u003C30, gadolinium allergy).","ALL","18 Years",{"count":109,"type":110},166,"ESTIMATED","INTERVENTIONAL",[113],"PHASE2","This is a randomized study to determine if not treating planning target volume (PTV) margins during radiation therapy worsens progression free survival rates in patients with brain metastases.",[116],"Brain Metastases",[118,66],"brain metastases","2026-09-11",{"date":121,"type":122},"2026-09-14","ACTUAL",{"date":124,"type":122},"2023-09-05",{"date":126,"type":110},"2028-08-22",{"name":5,"class":6},1]