[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100517793":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":11,"centralContacts":28,"locations":34,"responsibleParty":177,"collaborators":11,"id":179,"slug":180,"hasResults":181,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":181,"sex":187,"minAge":188,"maxAge":11,"enrollmentInfo":189,"targetDuration":11,"studyType":192,"phases":193,"briefSummary":195,"conditions":196,"keywords":198,"overallStatus":37,"whyStopped":11,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":213},{"fullName":5,"class":6},"Institut Claudius Regaud","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Radiation therapy followed by surgery","EXPERIMENTAL",null,[13,14],"Radiation: Hypofractionated Radiation Therapy","Procedure: Conservative treatment",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"RADIATION","Hypofractionated Radiation Therapy","The Hypofractionated Intensity-Modulated Radiation Therapy will be delivered in 5 fractions of 6 Gy each on the Planning Target Volume (PTV). The total dose of 30 Gy will be administered in approximately 1 week.",[9],[22],"Intensity-modulated radiation therapy (IMRT)",{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"PROCEDURE","Conservative treatment","A wide en bloc resection is required (amputation is excluded) while ensuring the best functional preservation. The surgical procedure will take place about 1,5 to 2 months after the end of the radiation therapy.",[9],[29],{"name":30,"role":31,"phone":32,"phoneExt":11,"email":33},"Justine ATTAL KHALIFA","CONTACT","05 31 15 54 38","AttalKhalifa.Justine@iuct-oncopole.fr",[35,52,65,78,91,104,117,130,143,156,164],{"facility":36,"status":37,"city":38,"state":11,"zip":11,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Institut Bergonie","RECRUITING","Bordeaux","France","FR",{"type":42,"coordinates":43},"Point",[44,45],-0.58046,44.84124,{"lat":45,"lon":44},[48],{"name":49,"role":31,"phone":50,"phoneExt":11,"email":51},"Pauline GILLON","05 56 33 33 43","p.gillon@bordeaux.unicancer.fr",{"facility":53,"status":37,"city":54,"state":11,"zip":11,"country":39,"countryCode":40,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"Centre Oscar Lambret","Lille",{"type":42,"coordinates":56},[57,58],3.05512,50.63391,{"lat":58,"lon":57},[61],{"name":62,"role":31,"phone":63,"phoneExt":11,"email":64},"Abel CORDOBA LARGO","03 20 29 59 59","a-cordoba@o-lambret.fr",{"facility":66,"status":37,"city":67,"state":11,"zip":11,"country":39,"countryCode":40,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Chu de Limoges","Limoges",{"type":42,"coordinates":69},[70,71],1.24759,45.83362,{"lat":71,"lon":70},[74],{"name":75,"role":31,"phone":76,"phoneExt":11,"email":77},"Hélène ORLIAC","05 55 05 62 68","helene.orliac@chu-limoges.fr",{"facility":79,"status":37,"city":80,"state":11,"zip":11,"country":39,"countryCode":40,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Centre Leon Berard","Lyon",{"type":42,"coordinates":82},[83,84],4.84789,45.74906,{"lat":84,"lon":83},[87],{"name":88,"role":31,"phone":89,"phoneExt":11,"email":90},"Waisse WAISSI","04 78 78 28 28","waisse.waissi@lyon.unicancer.fr",{"facility":92,"status":37,"city":93,"state":11,"zip":11,"country":39,"countryCode":40,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Institut Regional Du Cancer de Montpellier","Montpellier",{"type":42,"coordinates":95},[96,97],3.87635,43.61093,{"lat":97,"lon":96},[100],{"name":101,"role":31,"phone":102,"phoneExt":11,"email":103},"Carmen LLACER-MOSCARDO","04 67 61 37 79","carmen.llacer@icm.unicancer.fr",{"facility":105,"status":37,"city":106,"state":11,"zip":11,"country":39,"countryCode":40,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Institut Curie","Paris",{"type":42,"coordinates":108},[109,110],2.3488,48.85341,{"lat":110,"lon":109},[113],{"name":114,"role":31,"phone":115,"phoneExt":11,"email":116},"Sylvie HELFRE","01 44 32 46 25","sylvie.helfre@curie.net",{"facility":118,"status":37,"city":119,"state":11,"zip":11,"country":39,"countryCode":40,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Chu de Poitiers","Poitiers",{"type":42,"coordinates":121},[122,123],0.34348,46.58261,{"lat":123,"lon":122},[126],{"name":127,"role":31,"phone":128,"phoneExt":11,"email":129},"Sarah GARCIA MOLINA","05 49 44 44 44","sarah.garcia-molina@chu-poitiers.fr",{"facility":131,"status":37,"city":132,"state":11,"zip":11,"country":39,"countryCode":40,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Institut de Cancerologie de L'Ouest","Saint-Herblain",{"type":42,"coordinates":134},[135,136],-1.651,47.21154,{"lat":136,"lon":135},[139],{"name":140,"role":31,"phone":141,"phoneExt":11,"email":142},"Augustin MERVOYER","02 40 67 99 00","augustin.mervoyer@ico.unicancer.fr",{"facility":144,"status":37,"city":145,"state":11,"zip":11,"country":39,"countryCode":40,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Chu de Toulouse","Toulouse",{"type":42,"coordinates":147},[148,149],1.44367,43.60426,{"lat":149,"lon":148},[152],{"name":153,"role":31,"phone":154,"phoneExt":11,"email":155},"Louis COURTOT","05 61 77 21 04","courtot.l@chu-toulouse.fr",{"facility":157,"status":37,"city":145,"state":11,"zip":11,"country":39,"countryCode":40,"cosmosGeoPoint":158,"geoPoint":160,"contacts":161},"IUCT-O",{"type":42,"coordinates":159},[148,149],{"lat":149,"lon":148},[162],{"name":30,"role":31,"phone":32,"phoneExt":11,"email":163},"attalkhalifa.justine@iuct-oncopole.fr",{"facility":165,"status":37,"city":166,"state":11,"zip":11,"country":39,"countryCode":40,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"Institut Gustave Roussy","Villejuif",{"type":42,"coordinates":168},[169,170],2.35992,48.7939,{"lat":170,"lon":169},[173],{"name":174,"role":31,"phone":175,"phoneExt":11,"email":176},"Cécile LE PECHOUX","01 42 11 42 11","cecile.lepechoux@gustaveroussy.fr",{"type":178,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100517793","phase-2-a-study-to-evaluate-pre-operative-hypofractionated-radiation-therapy-in-aged--70-years-old-or-fragile--65-years-patients-with-limb-or-trunk-soft-tissue-sarcoma-100517793",false,"NCT06022159","A Study to Evaluate Pre-operative HYPOfractionated Radiation Therapy in Aged (≥ 70 Years Old) or \"Fragile\" (≥ 65 Years) Patients With Limb or Trunk Soft Tissue SARComa.","Phase II Study Evaluating Pre-operative HYPOfractionated Radiation Therapy in Aged (≥ 70 Years) or \"Fragile\" (≥ 65 Years) Patients With Limb or Trunk Soft Tissue SARComa.","HYPOSARC","Inclusion Criteria:\n\n1. Patient with histologically confirmed soft tissue sarcoma of the limbs or trunk.\n2. Indication for neo-adjuvant or adjuvant radiotherapy.\n3. Patient aged ≥ 70 years with a performance status ECOG ≤ 2 and\u002For aged 65 to 70 years with an ECOG of 2 and identified by the investigator as \"fragile\".\n4. Patient affiliated to a Social Health Insurance in France.\n5. Patient able to participate and willing to give informed consent prior performance of any study-related procedures.\n\nExclusion Criteria:\n\n1. Retroperitoneal, ORL and visceral sarcomas.\n2. Previous radiotherapy in the area.\n3. Metastatic disease.\n4. Concomitant or sequential chemotherapy.\n5. Patient requiring total surgery (amputation).\n6. Other cancer under treatment.\n7. Any condition or pathology contraindicating MRI.\n8. Any psychological, familial, geographic or social situation, potentially preventing the provision of informed consent or compliance to study procedure.\n9. Patients included in another therapeutic interventional trial.\n10. Patient who has forfeited his\u002Fher freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).","ALL","65 Years",{"count":190,"type":191},48,"ESTIMATED","INTERVENTIONAL",[194],"PHASE2","This is a phase II, multicenter, non-randomized study.\n\nThe main objective is to evaluate the treatment with hypofractionated radiation therapy in neo-adjuvant situations on wound healing in a population of aged patients (≥ 70 years old) or ≥ 65 years of age defined as \"fragile\" and treated for soft tissue sarcoma.\n\nA maximum of 48 evaluable patients will be included in this study. The patients will receive an hypofractionated radiation therapy prior to conservative surgery.\n\nEach patient will be followed for up to 3 years after the end of complete treatment (radiotherapy + surgery).",[197],"Soft Tissue Sarcoma",[197,199,200,201,202,203],"Limb soft tissue SARComa","Trunk soft tissue SARComa","Aged population","\"Fragile\" population","hypofractionated radiation therapy","2026-05-29",{"date":206,"type":207},"2026-06-02","ACTUAL",{"date":209,"type":207},"2023-11-28",{"date":211,"type":191},"2029-05",{"name":5,"class":6},11]