[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100523297":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":31,"responsibleParty":44,"collaborators":26,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":26,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":26,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":72,"whyStopped":26,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Shanghai Changzheng Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Decompression surgery + IORT","EXPERIMENTAL","Decompression surgery + IORT (15-20 Gy, 20-50min）",[13],"Radiation: Intraoperative radiotherapy (IORT)",{"label":15,"type":16,"description":17,"interventionNames":18},"Decompression surgery + postoperative SBRT","ACTIVE_COMPARATOR","Decompression surgery + postoperative SBRT (30Gy, 5 fractions, 3 weeks)",[19],"Radiation: Stereotactic body radiotherapy (SBRT)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"RADIATION","Intraoperative radiotherapy (IORT)","Intraoperative radiotherapy (IORT, 15-20 Gy, 20-50min)",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Stereotactic body radiotherapy (SBRT)","postoperative stereotactic body radiotherapy (SBRT, 30Gy, 5 fractions, 3 weeks)",[15],[32],{"facility":5,"status":26,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":26},"Shanghai","Shanghai Municipality","200003","China","CN",{"type":39,"coordinates":40},"Point",[41,42],121.45806,31.22222,{"lat":42,"lon":41},{"type":45,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Haifeng Wei, MD, PhD","Professor, Chief Surgeon","100523297","intraoperative-radiotherapy-in-treating-spinal-metastases-100523297",false,"NCT06093854","Intraoperative Radiotherapy in Treating Spinal Metastases","The Efficacy and Safety of Intraoperative Radiotherapy Vesus Stereotactic Body Radiotherapy in Managing Spinal Metastases: A Prospective, Single-center, Open-label, Non-inferior, Randomized Controlled Trial","Inclusion Criteria:\n\n* Clinical diagnosis of spinal metastases;\n* Estimated survival time more than 3 months;\n* The spinal instability neoplastic score (SINS) \\>12;\n* The general condition allows to recieve surgery;\n* Single or multiple metastatic lesions with only one site presenting epidural spinal cord compression;\n* signed informed consent.\n\nExclusion Criteria:\n\n* Clinical diagnosis of primary spinal tumors;\n* Presence of metastases in central nerve system;\n* Isolated lesion undergoing en bloc resection;\n* Mental disorder and\u002For intellectual dificiency;\n* Refusing to accept follow-up;\n* without signing informed consent.","ALL","35 Years","75 Years",{"count":59,"type":60},132,"ESTIMATED","INTERVENTIONAL",[63],"NA","In order to provide theoretical evidence for the comprehensive and standardized treatment of spinal metastases with pathological fractures and\u002For spinal cord compression, the investigators conduct this trial to investigate the efficacy and safety of IORT and postoperative SBRT in adjuvant treatment of metastatic spinal tumors after posterior decompression surgery by recruiting patients with spinal metastases who met the inclusion criteria, and randomly divided them into the following treatment cohorts: 1) decompression surgery + IORT (15-20 Gy, 20-50min）; 2) decompression surgery and postoperative SBRT(30Gy, 5 fractions, 3 weeks).",[66],"Spinal Metastases",[68,69,70,71],"spinal metastases","intraoperative radiotherapy","stereotactic body radiotherapy","decompression surgery","NOT_YET_RECRUITING","2023-10-20",{"date":75,"type":76},"2023-10-23","ACTUAL",{"date":78,"type":60},"2024-01",{"date":80,"type":60},"2027-01",{"name":5,"class":6},1]