[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603384":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":21,"centralContacts":27,"locations":33,"responsibleParty":51,"collaborators":21,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":21,"enrollmentInfo":64,"targetDuration":21,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":21,"overallStatus":35,"whyStopped":21,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"University Medical Center Goettingen","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Hypofractionated Stereotactic Body Radiotherapy + Surgery","EXPERIMENTAL","Participants will receive hypofractionated Stereotactic Body Radiotherapy (SBRT) to spinal metastases in 1-3 fractions within one week after informed consent. SBRT will be planned using MRI co-registered with planning CT and delivered following institutional immobilization standards and ESTRO guidelines. Surgical intervention will follow within a maximum of 10 days after informed consent and includes decompression of the spinal canal and\u002For dorsal instrumentation, depending on clinical indication.",[13,14],"Radiation: Preoperative Stereotactic Body Radiotherapy (SBRT)","Procedure: Spinal Surgery for Decompression and\u002For Stabilization",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"RADIATION","Preoperative Stereotactic Body Radiotherapy (SBRT)","Hypofractionated SBRT delivered in 1-3 fractions within 10 days before surgery, using MRI-based planning and institutional immobilization standards according to ESTRO guidelines.",[9],null,{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":21},"PROCEDURE","Spinal Surgery for Decompression and\u002For Stabilization","Surgical intervention is performed following SBRT, based on clinical indication. It includes decompression of the spinal canal in cases of spinal cord or nerve compression (via laminectomy and\u002For foraminotomy), and\u002For dorsal instrumentation for unstable spines using pedicle screws guided by a neuronavigation system (Brainlab, Munich, Germany)",[9],[28],{"name":29,"role":30,"phone":31,"phoneExt":21,"email":32},"Carla Marie Zwerenz, Dr. med.","CONTACT","+49 551 39 64501","carlamarie.zwerenz@med.uni-goettingen.de",[34],{"facility":5,"status":35,"city":36,"state":21,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"RECRUITING","Göttingen","37073","Germany","DE",{"type":41,"coordinates":42},"Point",[43,44],9.93228,51.53443,{"lat":44,"lon":43},[47],{"name":48,"role":30,"phone":49,"phoneExt":21,"email":50},"Anna-Lena Simmert","+49 551 39 64567","anna-lena.simmert@med.uni-goettingen.de",{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"PRINCIPAL_INVESTIGATOR","Prof. Dr. Rami El Shafie","Principal Investigator","100603384","preoperative-stereotactic-radiotherapy-for-treatment-of-spinal-metastases-100603384",false,"NCT07135817","Preoperative Stereotactic Radiotherapy for Treatment of Spinal Metastases","PRESTRASM","Inclusion Criteria:\n\n* Indication for surgical treatment of a spinal tumor\n* Age: older or 18 years\n* Estimated survival \\> 6 months\n* The patient is able to understand the nature, significance and scope of the clinical study in the context of patient information and to base the decision to participate in the study on this.\n\nExclusion Criteria:\n\n* Age: \\\u003C 18 years\n* Motor deficit or loss of bladder and bowel control that urges an emergency surgical decompression\n* Tumor extent does not allow hypofractioned SBRT (1-3 fractions)","ALL","18 Years",{"count":65,"type":66},20,"ESTIMATED","INTERVENTIONAL",[69],"NA","The goal of this interventional clinical trial is to evaluate the efficacy and safety of preoperative hypofractionated Stereotactic Body Radiotherapy (SBRT) in the treatment of patients undergoing surgery for spinal metastases.\n\nThe main questions this study aims to answer are:\n\n* Does preoperative SBRT result in local tumor control at the involved spinal segments as assessed by MRI\u002FCT scan at 3 and 6 months postoperatively?\n* What are the postoperative outcomes in terms of pain intensity, functional status and quality of life?\n\nParticipants will receive hypofractionated SBRT to spinal metastases shortly before surgical intervention.\n\nParticipants will undergo preoperative and follow-up assessments, including:\n\n* MRI and CT scans before and after surgery and at 3 and 6 months after surgery to measure tumor size\n* Pain questionnaires where patients rate their current pain, worst pain, and average pain in the last 24 hours on a scale from 0 (no pain) to 10 (worst pain imaginable)\n* A short questionnaire (Karnofsky Performance Status) to assess the patient's general ability to carry out daily activities\n* Several patient questionnaires to evaluate back pain, physical limitations, and overall quality of life (Oswestry Disability Index, EORTC QLQ-C30, and EORTC QLQ-BM22)",[72,73],"Spinal Metastases","Solid Tumor Cancer","2025-08-15",{"date":76,"type":77},"2025-08-22","ACTUAL",{"date":79,"type":77},"2025-08-01",{"date":81,"type":66},"2027-01",{"name":5,"class":6},1]