[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641320":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":40,"responsibleParty":239,"collaborators":25,"id":241,"slug":242,"hasResults":243,"nctId":244,"briefTitle":245,"officialTitle":245,"acronym":246,"eligibilityCriteria":247,"healthyVolunteers":243,"sex":248,"minAge":249,"maxAge":25,"enrollmentInfo":250,"targetDuration":25,"studyType":253,"phases":254,"briefSummary":256,"conditions":257,"keywords":260,"overallStatus":266,"whyStopped":25,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":276},{"fullName":5,"class":6},"Institut Cancerologie de l'Ouest","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Stereotactic Body Radiotherapy (SBRT)","EXPERIMENTAL","Participants will receive SBRT in 5 fractions. Treatment includes:\n\n* 20 Gy in 5 fractions to the involved vertebra and spinal canal, including adjacent superior and inferior hemi-vertebrae (elective volume), corresponding to a standard palliative dose; and\n* A simultaneous integrated boost to the tumor volume, defined per protocol guidelines, delivering 35 Gy in 5 fractions (7 Gy per fraction).\n\nTreatment planning will follow current guidelines with strict spinal cord and cauda equina dose constraints.",[13],"Radiation: Stereotactic Body Radiotherapy (SBRT)",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional Radiotherapy (palliative dose)","ACTIVE_COMPARATOR","Participants will receive conventional external beam radiotherapy delivered in 5 fractions, with a total dose of 20 Gy to the involved vertebra and spinal canal, including adjacent superior and inferior hemi-vertebrae, consistent with standard palliative treatment. Radiotherapy will be administered according to the standard practice of the investigating center, with attention to treating any epidural extension visible on MRI.\n\nThis arm is not intended for formal efficacy comparison but will support interpretation of study results and inform the design of a future comparative superiority trial if SRT demonstrates sufficient efficacy.",[19],"Radiation: Conventional External Beam Radiotherapy",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"RADIATION","Stereotactic body radiotherapy delivered in 5 fractions, consisting of 20 Gy to the involved vertebra and spinal canal (including adjacent hemi-vertebrae) with a simultaneous integrated boost to 35 Gy in 5 fractions to the tumor volume, according to protocol-defined delineation and dose constraints.",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Conventional External Beam Radiotherapy","Conventional external beam radiotherapy delivered in 5 fractions with a total dose of 20 Gy to the involved vertebra and spinal canal, including adjacent hemi-vertebrae, in accordance with standard palliative practice.",[15],[31],{"name":32,"affiliation":33,"role":34},"Loïg VAUGIER, MD","Institut de Cancérologie de l'Ouest","PRINCIPAL_INVESTIGATOR",[36],{"name":32,"role":37,"phone":38,"phoneExt":25,"email":39},"CONTACT","+33 2 40 67 99 00","Loïg.vaugier@ico.unicancer.fr",[41,58,72,86,100,114,128,142,156,170,183,197,211,225],{"facility":42,"status":25,"city":43,"state":25,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Institut de Cancerologie de L'Ouest","Angers","49055","France","FR",{"type":48,"coordinates":49},"Point",[50,51],-0.55202,47.47156,{"lat":51,"lon":50},[54],{"name":55,"role":37,"phone":56,"phoneExt":25,"email":57},"Jeremy COLLIAUX, MD","+33 2 41 35 27 00","jeremy.colliaux@ico.unicancer.fr",{"facility":59,"status":25,"city":60,"state":25,"zip":61,"country":45,"countryCode":46,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"CLCC Ste Catherine - Institut du cancer Avignon\u002FProvence","Avignon","84918",{"type":48,"coordinates":63},[64,65],4.80892,43.94834,{"lat":65,"lon":64},[68],{"name":69,"role":37,"phone":70,"phoneExt":25,"email":71},"Pierre TREMOLIERES, MD","+33 4 90 27 61 61","p.tremolieres@isc84.org",{"facility":73,"status":25,"city":74,"state":25,"zip":75,"country":45,"countryCode":46,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Chu de Brest","Brest","29200",{"type":48,"coordinates":77},[78,79],-4.48628,48.39029,{"lat":79,"lon":78},[82],{"name":83,"role":37,"phone":84,"phoneExt":25,"email":85},"Francois LUCIA, MD","+33 2 98 22 33 33","francois.lucia@univ-brest.fr",{"facility":87,"status":25,"city":88,"state":25,"zip":89,"country":45,"countryCode":46,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"CHD Vendée","La Roche-sur-Yon","85000",{"type":48,"coordinates":91},[92,93],-1.42757,46.66974,{"lat":93,"lon":92},[96],{"name":97,"role":37,"phone":98,"phoneExt":25,"email":99},"Emmanuelle REYGAGNE-VIERA, MD","+33 2 51 44 61 61","emmanuelle.reygagne-viera@ght85.fr",{"facility":101,"status":25,"city":102,"state":25,"zip":103,"country":45,"countryCode":46,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Centre Gillaume le Conquérant","Le Havre","76600",{"type":48,"coordinates":105},[106,107],0.10785,49.49346,{"lat":107,"lon":106},[110],{"name":111,"role":37,"phone":112,"phoneExt":25,"email":113},"Paul LESUEUR, MD","+33 2 35 13 66 13","p.lesueur@cglc.fr",{"facility":115,"status":25,"city":116,"state":25,"zip":117,"country":45,"countryCode":46,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Clinique Victor Hugo","Le Mans","72000",{"type":48,"coordinates":119},[120,121],0.20251,48.0021,{"lat":121,"lon":120},[124],{"name":125,"role":37,"phone":126,"phoneExt":25,"email":127},"Yoann POINTREAU, MD","+33 2 55 46 37 00","essaispointreau@ilcgroupe.fr",{"facility":129,"status":25,"city":130,"state":25,"zip":131,"country":45,"countryCode":46,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Groupe Hospitalier Bretagne Sud (GHBS)","Lorient","56322",{"type":48,"coordinates":133},[134,135],-3.37177,47.74817,{"lat":135,"lon":134},[138],{"name":139,"role":37,"phone":140,"phoneExt":25,"email":141},"Guillaume BERA, MD","+33 2 97 06 90 90","g.bera@ghbs.bzh",{"facility":143,"status":25,"city":144,"state":25,"zip":145,"country":45,"countryCode":46,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Institut de Cancérologie Radiothérapie Bretillien (ICRB)","Rennes","35760",{"type":48,"coordinates":147},[148,149],-1.67431,48.11109,{"lat":149,"lon":148},[152],{"name":153,"role":37,"phone":154,"phoneExt":25,"email":155},"Francois RIET, MD","+33 2 99 23 33 33","francois.riet@icrb.fr",{"facility":157,"status":25,"city":158,"state":25,"zip":159,"country":45,"countryCode":46,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"Centre Henri Becquerel","Rouen","76038",{"type":48,"coordinates":161},[162,163],1.09932,49.44313,{"lat":163,"lon":162},[166],{"name":167,"role":37,"phone":168,"phoneExt":25,"email":169},"Sébastien THUREAU, MD","+33 2 32 08 22 22","sebastien.thureau@chb.unicancer.fr",{"facility":33,"status":25,"city":171,"state":25,"zip":172,"country":45,"countryCode":46,"cosmosGeoPoint":173,"geoPoint":177,"contacts":178},"Saint-Herblain","44805",{"type":48,"coordinates":174},[175,176],-1.651,47.21154,{"lat":176,"lon":175},[179,182],{"name":180,"role":37,"phone":38,"phoneExt":25,"email":181},"Martin LANGE, MD","martin.lange@ico.unicancer.fr",{"name":180,"role":34,"phone":25,"phoneExt":25,"email":25},{"facility":184,"status":25,"city":185,"state":25,"zip":186,"country":45,"countryCode":46,"cosmosGeoPoint":187,"geoPoint":191,"contacts":192},"Clinique mutualiste de l'Estuaire","Saint-Nazaire","44600",{"type":48,"coordinates":188},[189,190],-2.2179,47.27506,{"lat":190,"lon":189},[193],{"name":194,"role":37,"phone":195,"phoneExt":25,"email":196},"Vincent LIBOIS, MD","+33 2 72 27 53 00","vincent.libois@hospigrandouest.fr",{"facility":198,"status":25,"city":199,"state":25,"zip":200,"country":45,"countryCode":46,"cosmosGeoPoint":201,"geoPoint":205,"contacts":206},"Clinique de la Côte d'Emeraude","St-Malo","35400",{"type":48,"coordinates":202},[203,204],-2.00877,48.64738,{"lat":204,"lon":203},[207],{"name":208,"role":37,"phone":209,"phoneExt":25,"email":210},"Nicolas JAKSIC, MD","+33 2 23 52 20 20","nicolas.jaksic@icrb.fr",{"facility":212,"status":25,"city":213,"state":25,"zip":214,"country":45,"countryCode":46,"cosmosGeoPoint":215,"geoPoint":219,"contacts":220},"Chru Bretonneau","Tours","37044",{"type":48,"coordinates":216},[217,218],0.70398,47.39484,{"lat":218,"lon":217},[221],{"name":222,"role":37,"phone":223,"phoneExt":25,"email":224},"Astrid THOMIN, MD","+33 2 47 47 47 76","a.thomin@chu-tours.fr",{"facility":226,"status":25,"city":227,"state":25,"zip":228,"country":45,"countryCode":46,"cosmosGeoPoint":229,"geoPoint":233,"contacts":234},"Clinique Saint Yves","Vannes","56000",{"type":48,"coordinates":230},[231,232],-2.76205,47.65688,{"lat":232,"lon":231},[235],{"name":236,"role":37,"phone":237,"phoneExt":25,"email":238},"Osman EL KABBAJ, MD","+33 2 97 62 50 00","o.elkabbaj@centre-st-yves.fr",{"type":240,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100641320","stereotactic-radiotherapy-for-spinal-metastases-with-limited-extent-of-epidural-disease-100641320",false,"NCT07656883","Stereotactic Radiotherapy for SPinal Metastases With Limited Extent of Epidural Disease","SPEED-RT","Inclusion Criteria:\n\n* Histologically confirmed solid tumor;\n* Vertebral bone metastasis located between C2 and S1 (inclusive) with epiduritis (spinal cord or cauda equina) without clinical and\u002For radiological spinal cord compression on MRI;\n* Performance status (PS) ≤ 1;\n* Spinal Instability Neoplastic Score (SINS) ≤12;\n* Patient has been informed and has provided freely given, written, and signed informed consent;\n* Patient is affiliated with or a beneficiary of the national health insurance system.\n\nExclusion Criteria:\n\n* Neurological deficit attributable to spinal cord compression or cauda equina syndrome;\n* Patient experiencing pain that prevents lying down for 30 minutes despite optimal analgesic treatment;\n* Life expectancy ≤6 months as estimated by the investigator;\n* Neurosurgical indication (preventive or decompressive) prior to radiotherapy;\n* More than one epiduritis lesion requiring treatment;\n* Prior surgery on the same vertebra targeted in the protocol;\n* Epiduritis and\u002For bone lesion extending over more than three contiguous vertebral levels;\n* Previous irradiation of the spine with cumulative dose with cumulative spinal cord dose EQD2 \\>50 Gy, α\u002Fβ = 2;\n* Contraindication to MRI;\n* Pregnant or breastfeeding woman;\n* Patient under legal protection, guardianship, or unable to provide informed consent;\n* Inability to comply with study follow-up due to geographic, social, or psychological reasons.","ALL","18 Years",{"count":251,"type":252},167,"ESTIMATED","INTERVENTIONAL",[255],"NA","This study evaluates a new radiation treatment approach for patients with cancer that has spread to the spine (vertebral metastases) and involves limited extension around the spinal cord without causing compression (non-compressive epiduritis). This condition is common and can lead to serious complications, including pain and spinal cord compression, potentially affecting mobility and quality of life.\n\nThe current standard of care is conventional radiotherapy, which is effective for symptom relief but may provide limited long-term tumor control. As advances in cancer treatments have improved survival, there is an increasing need for treatment approaches that better prevent local tumor progression in the spine.\n\nThis randomized clinical trial compares standard radiotherapy with stereotactic radiotherapy (SRT), an advanced and highly precise radiation technique that delivers higher doses directly to the tumor while minimizing exposure to surrounding healthy tissues, including the spinal cord.\n\nThe primary objective is to determine whether SRT can improve local disease control while maintaining an acceptable safety profile. The study will evaluate the proportion of patients who are alive without spinal disease progression (including spinal cord compression or local tumor recurrence) at one year after treatment. Secondary outcomes include treatment-related side effects, time to disease progression, overall survival, quality of life, feasibility of delivering SRT within a defined timeframe, risk of vertebral fractures, and need for additional radiation treatment.\n\nEligible patients will have an estimated life expectancy greater than six months. Strict radiation dose constraints will be applied to minimize the risk of spinal cord injury, and patient safety will be closely monitored, including implementation of an early stopping rule in case of unexpected severe toxicity.\n\nThe hypothesis of the study is that stereotactic radiotherapy will improve local control of spinal metastases compared with standard radiotherapy, without increasing the risk of serious adverse effects.",[258,259],"Epiduritis","Vertebral Bone Metastasis",[261,262,263,264,9,265],"Epidural Disease","Spinal Cord Compression","Palliative Radiotherapy","Spinal Metastases","Radiation Therapy","NOT_YET_RECRUITING","2026-06-16",{"date":269,"type":270},"2026-06-18","ACTUAL",{"date":272,"type":252},"2026-10",{"date":274,"type":252},"2030-10",{"name":5,"class":6},14]