[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100358778":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":42,"responsibleParty":146,"collaborators":26,"id":148,"slug":149,"hasResults":150,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":150,"sex":156,"minAge":157,"maxAge":26,"enrollmentInfo":158,"targetDuration":26,"studyType":161,"phases":162,"briefSummary":164,"conditions":165,"keywords":167,"overallStatus":172,"whyStopped":26,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":182},{"fullName":5,"class":6},"Institut Cancerologie de l'Ouest","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"RSHF + zoledronic acid","EXPERIMENTAL","Patients receive RSHF according to : 30 Gy in 5 fractions of 6 Gy spaced 48 hours or 27 Gy in 3 fractions of 9 Gy spaced 48 hours or 20 Gy in 1 fraction. combined with zoledronic acid (4 mg IV slow monthly for 12 months, dose adjusted according to creatinine clearance).",[13],"Combination Product: Zoledronic Acid 4Mg Solution for Injection + Hypo-fractured radiotherapy in stereotactic conditions",{"label":15,"type":16,"description":17,"interventionNames":18},"RSHF","ACTIVE_COMPARATOR","Patients receive only RSHF according to : 30 Gy in 5 fractions of 6 Gy spaced 48 hours or 27 Gy in 3 fractions of 9 Gy spaced 48 hours or 20 Gy in 1 fraction.",[19],"Radiation: Hypo-fractured radiotherapy in stereotactic conditions",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"COMBINATION_PRODUCT","Zoledronic Acid 4Mg Solution for Injection + Hypo-fractured radiotherapy in stereotactic conditions","All patients receive radiotherapy i.e. treatment on D1, D3 and D5.\n\nSeveral radiotherapy schemes are possible:\n\n* 20 Gy in 1 fraction;\n* 27 Gy in 3 fractions of 9 Gy\n* 30 Gy in 5 fractions of 6 Gy. All patients in the experimental arm receive an intravenous injection of at least 15 minutes of 4 mg zoledronic acid every month for 12 months.\n\nThe first injection must be made no more than 3 weeks before the first day of radiotherapy. It can be performed up to J1 of radiotherapy.\n\nThe injections will be carried out either at the patient's home by the nurses or in the investigator centre.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"RADIATION","Hypo-fractured radiotherapy in stereotactic conditions","All patients receive radiotherapy i.e. treatment on D1, D3 and D5.\n\nSeveral radiotherapy schemes are possible:\n\n* 20 Gy in 1 fraction;\n* 27 Gy in 3 fractions of 9 Gy\n* 30 Gy in 5 fractions of 6 Gy.",[15],[33],{"name":34,"affiliation":35,"role":36},"Stéphane SUPIOT, MD","ICO site SAINT HERBLAIN","STUDY_DIRECTOR",[38],{"name":34,"role":39,"phone":40,"phoneExt":26,"email":41},"CONTACT","+33240679900","stephane.supiot@ico.unicancer.fr",[43,62,76,91,105,119,134],{"facility":44,"status":45,"city":46,"state":26,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Institut BERGONIE","RECRUITING","Bordeaux","33000","France","FR",{"type":51,"coordinates":52},"Point",[53,54],-0.58046,44.84124,{"lat":54,"lon":53},[57,60],{"name":58,"role":39,"phone":26,"phoneExt":26,"email":59},"Stéphanie BATARD, MD","s.batard@bordeaux.unicancer.fr",{"name":58,"role":61,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"facility":63,"status":45,"city":64,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Institut de Cancérologie de Lorraine","Nancy",{"type":51,"coordinates":66},[67,68],6.18496,48.68439,{"lat":68,"lon":67},[71,74],{"name":72,"role":39,"phone":26,"phoneExt":26,"email":73},"JEAN-CHRISTOPHE FAIVRE, MD","jc.faivre@nancy.unicancer.fr",{"name":75,"role":61,"phone":26,"phoneExt":26,"email":26},"Jean-Christophe FAIVRE, MD",{"facility":77,"status":78,"city":79,"state":26,"zip":80,"country":48,"countryCode":49,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Hôpital Privé du Confluent","NOT_YET_RECRUITING","Nantes","44277",{"type":51,"coordinates":82},[83,84],-1.55336,47.21725,{"lat":84,"lon":83},[87,90],{"name":88,"role":39,"phone":26,"phoneExt":26,"email":89},"Xavier BUTHAUD, MD","xavier.buthaud@groupeconfluent.fr",{"name":88,"role":61,"phone":26,"phoneExt":26,"email":26},{"facility":92,"status":78,"city":93,"state":26,"zip":94,"country":48,"countryCode":49,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Centre de Haute Energie","Nice","06000",{"type":51,"coordinates":96},[97,98],7.26608,43.70313,{"lat":98,"lon":97},[101,104],{"name":102,"role":39,"phone":26,"phoneExt":26,"email":103},"René-Jean BENSADOUN, MD","renejean.bensadoun@che-nice.com",{"name":102,"role":61,"phone":26,"phoneExt":26,"email":26},{"facility":106,"status":45,"city":107,"state":26,"zip":108,"country":48,"countryCode":49,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Hopital Lyon Sud","Pierre-Bénite","69310",{"type":51,"coordinates":110},[111,112],4.82424,45.70359,{"lat":112,"lon":111},[115,118],{"name":116,"role":39,"phone":26,"phoneExt":26,"email":117},"Ariane LAPIERRE, MD","ariane.lapierre@chu-lyon.fr",{"name":116,"role":61,"phone":26,"phoneExt":26,"email":26},{"facility":120,"status":45,"city":121,"state":26,"zip":122,"country":48,"countryCode":49,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Centre Henri Becquerel","Rouen","76038",{"type":51,"coordinates":124},[125,126],1.09932,49.44313,{"lat":126,"lon":125},[129,132],{"name":130,"role":39,"phone":26,"phoneExt":26,"email":131},"SEBASTIEN THUREAU, MD","sebastien.thureau@chb.unicancer.fr",{"name":133,"role":61,"phone":26,"phoneExt":26,"email":26},"Sébastien THUREAU, MD",{"facility":135,"status":45,"city":136,"state":26,"zip":137,"country":48,"countryCode":49,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"Stéphane SUPIOT","Saint-Herblain","44805",{"type":51,"coordinates":139},[140,141],-1.651,47.21154,{"lat":141,"lon":140},[144,145],{"name":34,"role":39,"phone":40,"phoneExt":26,"email":41},{"name":34,"role":61,"phone":26,"phoneExt":26,"email":26},{"type":147,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100358778","phase-3-multicentre-medical-economic-study-evaluating-the-efficacy-of-adding-zoldronique-acid-to-sterotaxique-radiotherapy-in-the-treatment-of-vertebral-metastases-100358778",false,"NCT03951493","Multicentre Medical-economic Study Evaluating the Efficacy of Adding ZOlédronique Acid to STERéotaxique Radiotherapy in the Treatment of Vertebral Metastases","Phase III Randomized, Controlled, Open, Multicentre Medical-economic Study Evaluating the Efficacy of Adding ZOlédronique Acid to STERéotaxique Radiotherapy in the Treatment of Vertebral Metastases","ZOSTER","Inclusion Criteria:\n\n* Cancer with inoperable thoracic and\u002For lumbar vertebral metastasis;\n* Age ≥ 18 years old ;\n* Life expectancy greater than 1 year;\n* OMS or PS ≤ 2 ;\n* Effective contraception for women of childbearing age;\n* Patient information and free, informed and written consent, signed by the patient and investigator;\n* Patient affiliated or beneficiary of the social security system.\n\nExclusion Criteria:\n\n* Cancer with inoperable thoracic and\u002For lumbar vertebral metastasis;\n* Painful patient unable to maintain a lying position for 30 minutes despite analgesic treatment;\n* Patient who has received external irradiation from the proposed irradiation area \\> 20 Gy ;\n* Signs of neurological compression;\n* Spinal cord compression or epidural damage requiring surgery before radiotherapy;\n* Clinically significant hypersensitivity to zoledronic acid, other bisphosphonates or any excipient;\n* History of osteonecrosis of the maxilla or bone exposure or delayed healing after dental surgery;\n* Previous (less than 2 years) or ongoing treatment with a bisphosphonate;\n* Creatinine clearance \\\u003C 30 ml\u002Fmin;\n* Pregnant or breastfeeding woman;\n* Patient protected or under guardianship or incapable of giving consent;\n* Impossibility to submit to the medical follow-up of the trial for geographical, social or psychological reasons.","ALL","18 Years",{"count":159,"type":160},225,"ESTIMATED","INTERVENTIONAL",[163],"PHASE3","Hypo-fractured radiotherapy in stereotactic conditions (RSHF) of bone metastases allows high doses to be delivered to the affected bone segment while sparing adjacent healthy tissues as well as possible. In addition, it not only reduces pain and prevents spinal cord compression, but also improves long-term control of metastatic disease.\n\nZoledronic acid reduces bone complications. The economic literature shows that stereotactic radiotherapy, like zoledronic acid, are cost-effective strategies in these indications. The objective of this research project is to evaluate the efficiency of adding zoledronic acid to stereotactic radiotherapy in the treatment of vertebral metastases.",[166],"Vertebral Metastasis",[168,169,170,171],"Hypo-fractured radiotherapy in stereotactic conditions (RSHF)","zoledronic acid","medico-economic","vertebral compressive fracture","UNKNOWN","2022-04-21",{"date":175,"type":176},"2022-04-28","ACTUAL",{"date":178,"type":176},"2020-06-23",{"date":180,"type":160},"2023-11-01",{"name":5,"class":6},7]