[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100481131":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":32,"locations":42,"responsibleParty":166,"collaborators":168,"id":172,"slug":26,"hasResults":173,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":173,"sex":179,"minAge":180,"maxAge":26,"enrollmentInfo":181,"targetDuration":26,"studyType":184,"phases":185,"briefSummary":187,"conditions":188,"keywords":190,"overallStatus":45,"whyStopped":26,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":204},{"fullName":5,"class":6},"Istituto Clinico Humanitas","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"HSRS pre-operative","EXPERIMENTAL","Patients undergo HSRS (hypofractionated Radiosurgery) on day 1, consisting in 27 Gray (gy) administered in 3 daily fractions.\n\nWithin 1 weeks, patients undergo surgical resection.",[13,14],"Radiation: Hypofractionated Radiosurgery (HSRS)","Procedure: Brain metastases surgical resection",{"label":16,"type":17,"description":18,"interventionNames":19},"HSRS post-operative","ACTIVE_COMPARATOR","Patients undergo surgical resection on day 1. Within 4-6 weeks, patients undergo HSRS (hypofractionated Radiosurgery), consisting in 27 Gray (gy) administered in 3 daily fractions.",[13,14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"RADIATION","Hypofractionated Radiosurgery (HSRS)","HSRS converges multiple radiation beams to deliver a single, large dose of radiation to a discrete tumor target with high precision, thereby minimizing radiation dose to the surrounding normal tissue.",[16,9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"PROCEDURE","Brain metastases surgical resection","Complete surgical resection of brain lesions with adeguate margins.",[16,9],[33,38],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},"Pierina Navarria, MD","CONTACT","+39 028224 7458","pierina.navarria@cancercenter.humanitas.it",{"name":39,"role":35,"phone":40,"phoneExt":26,"email":41},"Federico Pessina, MD","+39 028224 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Terni","Terni","05100",{"type":50,"coordinates":156},[157,158],12.64329,42.56335,{"lat":158,"lon":157},[161,164],{"name":162,"role":35,"phone":26,"phoneExt":26,"email":163},"Paola Anselmo, MD, radiation oncologist","p.anselmo@aospterni.it",{"name":165,"role":60,"phone":26,"phoneExt":26,"email":26},"Fabio Trippa, MD, radiation oncologist",{"type":167,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[169],{"name":170,"class":171},"Brainlab AG","INDUSTRY","100481131",false,"NCT05545007","Preoperative vs Postoperative Hypofractionated Radiosurgery for Patients With Large Brain Metastases","Phase III Randomized Trial Comparing Preoperative Hypofractionated Radiosurgery (HSRS) to Postoperative Hypofractionated Radiosurgery (HSRS) for Patients With Large Brain Metastases (= 2.1cm) Suitable for Surgical Resection","SUPPORT","Inclusion Criteria:\n\n* Age \\>18 years\n* Histological or cytological or radiological confirmation of solid tumor malignancy\n* Clinical indication for surgical resection of one brain metastasis\n* Karnosky performance status (KPS) ≥70\n* Controlled or responsive extra cranial metastatic lesions\n* Limited brain metastases (1-4 BMs)\n* Single metastatic lesion ≥ 2.1 cm in maximum diameter (4 cm3)\n* Lesions ≤2 cm conditioning mass effect or neurological deficits or massive edema unresponsive to steroids\n* Written informed consent form\n\nExclusion Criteria:\n\n* Prior WBRT\n* KPS \\\u003C 70\n* Diagnosis of small cell lung cancer (SCLC), germinal cell tumour or Lymphoproliferative disease\n* Pregnant women\n* Prior open neurosurgery for malignancy\n* More than 4 brain metastases\n* Patients with incompatibility to perform MRI","ALL","18 Years",{"count":182,"type":183},146,"ESTIMATED","INTERVENTIONAL",[186],"NA","This is a phase III randomized trial with the aim to compare preoperative HSRS to postoperative HSRS in patients with large at least one BMs from solid tumors 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