[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100343329":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":82,"centralContacts":86,"locations":92,"responsibleParty":156,"collaborators":30,"id":158,"slug":159,"hasResults":160,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":30,"eligibilityCriteria":164,"healthyVolunteers":160,"sex":165,"minAge":166,"maxAge":30,"enrollmentInfo":167,"targetDuration":30,"studyType":170,"phases":171,"briefSummary":173,"conditions":174,"keywords":30,"overallStatus":95,"whyStopped":30,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":186},{"fullName":5,"class":6},"Mayo Clinic","OTHER",[8,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A (Post-operative SRS)","ACTIVE_COMPARATOR","Patients undergo surgery on day 1. Within 2 weeks, patients undergo stereotactic radiosurgery. Patients also undergo a planning CT or MRI before radiation and tissue and CSF sample collection at time of surgery. Additionally, patients undergo MRI and option blood sample collection throughout the study.",[13,14,15,16,17,18],"Procedure: Conventional Surgery","Other: Questionnaire Administration","Radiation: Stereotactic Radiosurgery","Procedure: Computed Tomography","Procedure: Magnetic Resonance Imaging","Procedure: Biospecimen Collection",{"label":20,"type":21,"description":22,"interventionNames":23},"Arm B (Pre-operative SRS)","EXPERIMENTAL","Patients undergo stereotactic radiosurgery on day 1. Within 4 weeks, patients undergo surgery. Patients also undergo a planning CT or MRI before radiation and tissue and CSF sample collection at time of surgery and MRI throughout the study. Additionally, patients undergo MRI and option blood sample collection throughout the study.",[13,14,15,16,17,18],[25,31,35,48,59,75],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"PROCEDURE","Conventional Surgery","Undergo surgery",[9,20],null,{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Questionnaire Administration","Ancillary studies",[9,20],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"RADIATION","Stereotactic Radiosurgery","Undergo stereotactic radiosurgery",[9,20],[41,42,43,44,45,46,47],"Stereotactic External Beam Irradiation","stereotactic external-beam radiation therapy","Stereotactic Radiation Therapy","Stereotactic Radiotherapy","stereotaxic radiation therapy","stereotaxic radiosurgery","SRS",{"type":26,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"Computed Tomography","Undergo CT",[9,20],[53,54,55,56,57,58],"CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized Tomography","CT","CT Scan",{"type":26,"name":60,"description":61,"armGroupLabels":62,"otherNames":63},"Magnetic Resonance Imaging","Undergo MRI",[9,20],[64,65,66,67,68,69,70,71,72,73,74],"Medical Imaging","Magnetic Resonance \u002F Nuclear Magnetic Resonance","MR","MRI","MRI Scan","MRIs","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging","Structural MRI","sMRI",{"type":26,"name":76,"description":77,"armGroupLabels":78,"otherNames":79},"Biospecimen Collection","Undergo blood sample, tissue and CSF sample collection",[9,20],[80,81],"Biological Sample Collection","Specimen Collection",[83],{"name":84,"affiliation":5,"role":85},"Elizabeth Yan, M.D.","PRINCIPAL_INVESTIGATOR",[87],{"name":88,"role":89,"phone":90,"phoneExt":30,"email":91},"Clinical Trials Referral Office","CONTACT","855-776-0015","mayocliniccancerstudies@mayo.edu",[93,111,125,142],{"facility":94,"status":95,"city":96,"state":97,"zip":98,"country":99,"countryCode":100,"cosmosGeoPoint":101,"geoPoint":106,"contacts":107},"Mayo Clinic in Arizona","RECRUITING","Scottsdale","Arizona","85259","United States","US",{"type":102,"coordinates":103},"Point",[104,105],-111.89903,33.50921,{"lat":105,"lon":104},[108,109],{"name":88,"role":89,"phone":90,"phoneExt":30,"email":91},{"name":110,"role":85,"phone":30,"phoneExt":30,"email":30},"Sujay A. Vora, M.D.",{"facility":112,"status":95,"city":113,"state":114,"zip":115,"country":99,"countryCode":100,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"Mayo Clinic in Florida","Jacksonville","Florida","32224-9980",{"type":102,"coordinates":117},[118,119],-81.65565,30.33218,{"lat":119,"lon":118},[122,123],{"name":88,"role":89,"phone":90,"phoneExt":30,"email":91},{"name":124,"role":85,"phone":30,"phoneExt":30,"email":30},"Daniel Trifiletti, M.D.",{"facility":126,"status":95,"city":127,"state":128,"zip":129,"country":99,"countryCode":100,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"National Institutes of Neurological Disorders and Stroke, NIH","Bethesda","Maryland","20892",{"type":102,"coordinates":131},[132,133],-77.10026,38.98067,{"lat":133,"lon":132},[136,140],{"name":137,"role":89,"phone":138,"phoneExt":30,"email":139},"DeeDee K. Brown, M.D., Ph.D.","301-496-5457","smartd@mail.nih.gov",{"name":141,"role":85,"phone":30,"phoneExt":30,"email":30},"DeeDee K. Smart, M.D., Ph.D.",{"facility":143,"status":95,"city":144,"state":145,"zip":146,"country":99,"countryCode":100,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"Mayo Clinic in Rochester","Rochester","Minnesota","55905",{"type":102,"coordinates":148},[149,150],-92.4699,44.02163,{"lat":150,"lon":149},[153,154],{"name":88,"role":89,"phone":90,"phoneExt":30,"email":91},{"name":155,"role":85,"phone":30,"phoneExt":30,"email":30},"Elizabeth S. Yan, M.D.",{"type":157,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100343329","phase-3-pre-operative-or-post-operative-stereotactic-radiosurgery-in-treating-patients-with-operative-metastatic-brain-tumors-100343329",false,"NCT03750227","Pre-Operative or Post-Operative Stereotactic Radiosurgery in Treating Patients With Operative Metastatic Brain Tumors","Pre-Operative vs. Post-Operative Stereotactic Radiosurgery for Operative Metastatic Brain Tumors","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Histological or cytological confirmation of solid tumor malignancy and\u002For clinical history of known or suspected metastatic disease with an intraparenchymal brain tumor consistent with brain metastasis based on clinical and radiologic findings\n* Clinical indication for surgical resection of one brain metastasis based on neurosurgery recommendation and patient deemed a surgical candidate\n* Clinical indication and plan for stereotactic radiosurgery to all known brain lesions requiring treatment (=\\\u003C 10 metastases)\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\\\u003C 2\n* Provide written informed consent or have a legally authorized representative who is responsible for the care and well-being of the potential study participant, provide consent\n* Willing to continue follow-up visits, either at the enrolling institution or with a local medical doctor as clinically appropriate, and according to the study timeline. Clinical notes and digital copies of imaging must be provided to the enrolling site if follow-up is done externally\n\nExclusion Criteria:\n\n* Any of the following:\n\n  * Pregnant women\n  * Nursing women\n  * Men or women of childbearing potential who are unwilling to employ adequate contraception\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy. \\* NOTE: Patients known to be HIV, but without clinical evidence of an immunocompromised state, are eligible for this trial\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Prior open neurosurgery for malignancy\n* Known or clinically suspected primary germ cell tumor, small cell carcinoma, or lymphoma\n* History of whole brain radiation therapy (WBRT)\n* Known allergy to gadolinium, pacemaker, or other contraindication such as metal implant that is not safe for MRI. Patients with MRI-compatible implants including MRI compatible pacemakers are eligible\n* Leptomeningeal metastasis\u002Fdisease\n* A brain metastasis that is located =\\\u003C 5 mm of the optic chiasm\n* Any brain metastasis \\> 5 cm in size\n* \\> 10 brain metastases\n* Indication for surgical resection of \\>= 2 brain metastases\n* Indication for long-term (anticipated greater than 4 weeks) 4 mg dexamethasone equivalent of steroids or bevacizumab\n* Actively enrolled on another brain metastases trial that is assessing the efficacy of either radiation or surgical interventions","ALL","18 Years",{"count":168,"type":169},140,"ESTIMATED","INTERVENTIONAL",[172],"PHASE3","This phase III trial studies the side effects and how well stereotactic radiosurgery (SRS) works before or after surgery in patients with tumors that has spread to the brain or that can be removed by surgery. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue.",[175,176],"Malignant Solid Neoplasm","Metastatic Malignant Neoplasm in the Brain","2026-06-12",{"date":179,"type":180},"2026-06-16","ACTUAL",{"date":182,"type":180},"2018-11-19",{"date":184,"type":169},"2030-11-08",{"name":5,"class":6},4]