[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100483460":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":43,"responsibleParty":63,"collaborators":66,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":25,"enrollmentInfo":79,"targetDuration":25,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"UMC Utrecht","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","Patients will receive high dose, single fraction stereotactic body radiotherapy (SBRT) using differential dosing: 18 or 21 Gy on the metastasis. Within 24 hours after SBRT, patients will have surgical stabilization with or without decompression.",[13],"Other: Same-day SBRT and spinal surgery",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","ACTIVE_COMPARATOR","Patients will undergo the standard of care, which is surgical stabilization with or without decompression, followed by conventional radiotherapy (cRT) or SBRT as soon as the wound is healed sufficiently.",[19],"Other: Standard of care",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Same-day SBRT and spinal surgery","SBRT and surgical stabilization with or without decompression within 24 hours",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Standard of care","Surgical stabilization with or without decompression followed by cRT or SBRT as soon as the wound is healed sufficiently",[15],[31],{"name":32,"affiliation":5,"role":33},"Helena M. Verkooijen, Prof","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Roxanne Gal, PhD","CONTACT","+31 88 75 69624","R.Gal@umcutrecht.nl",{"name":41,"role":37,"phone":25,"phoneExt":25,"email":42},"Eline Huele, MSc","E.H.Huele-3@umcutrecht.nl",[44],{"facility":45,"status":46,"city":47,"state":25,"zip":25,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"University Medical Center Utrecht","RECRUITING","Utrecht","Netherlands","NL",{"type":51,"coordinates":52},"Point",[53,54],5.12222,52.09083,{"lat":54,"lon":53},[57,60,62],{"name":58,"role":37,"phone":25,"phoneExt":25,"email":59},"Helena M. Verkooijen, MD, PhD","H.M.Verkooijen@umcutrecht.nl",{"name":36,"role":61,"phone":25,"phoneExt":25,"email":25},"SUB_INVESTIGATOR",{"name":58,"role":33,"phone":25,"phoneExt":25,"email":25},{"type":33,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Helena M Verkooijen","Prof. H.M. Verkooijen",[67],{"name":68,"class":6},"Radboud University Medical Center","100483460","randomized-trial-on-same-day-sbrt-and-surgical-stabilization-for-symptomatic-spinal-metastases-100483460",false,"NCT05575323","Randomized Trial on Same-day SBRT and Surgical Stabilization for Symptomatic Spinal Metastases","Stereotactic Body Radiotherapy and pedicLE Screw fixatioN During One Hospital Visit for Patients With Painful Unstable Spinal Metastases: A Randomized Trial (BLEND)","BLEND","Inclusion Criteria:\n\n* Symptomatic (cervical, thoracic and\u002For lumbar) spinal metastases from solid tumors and (impending) spinal instability requiring radiotherapy and surgical decompression and\u002For stabilization\n* Histologic proof of malignancy or radiographic\u002Fclinical characteristics indicating malignancy beyond reasonable doubt\n* Radiographic evidence of spinal metastases\n* Participation in PRESENT cohort, including consent for randomization into future trials\n* Fit for (radio)surgery\n* Age \\>18 years\n* Written informed consent\n\nExclusion Criteria:\n\n* SBRT cannot be delivered, e.g. in patients who cannot lie on the treatment table because of pain\n* Routine surgical decompression and\u002For stabilization and radiotherapy cannot be performed, e.g., multiple spinal metastases requiring surgical bridging of more than five vertebral levels and\u002For requiring radiotherapy on more than one location\n* Prior surgery or radiotherapy to the index level(s)\n* Multiple myeloma\n* Neurological deficits (ASIA C, B or A), or partial neurological deficits (ASIA D) with rapid progression (hours to days)\n* Treated with Bevacizumab and other medication with long half-life that interferes with radiotherapy\n* Life expectancy of less than 3 months","ALL","18 Years",{"count":80,"type":81},100,"ESTIMATED","INTERVENTIONAL",[84],"NA","The BLEND RCT aims to evaluate the (cost-)effectiveness of same-day SBRT and surgical stabilization with or without decompression for the treatment of symptomatic, unstable spinal metastases on physical functioning four weeks after the start of treatment, compared with the standard of care (surgery followed by radiotherapy as soon as the wound healed sufficiently).",[87],"Spinal Metastases",[89,90,91,92,93],"Spinal metastases","SBRT","Surgery","Same-day treatment","RCT","2026-05-04",{"date":96,"type":97},"2026-05-08","ACTUAL",{"date":99,"type":97},"2022-10-15",{"date":101,"type":81},"2027-06-30",{"name":5,"class":6},1]