[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100520170":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":38,"locations":44,"responsibleParty":65,"collaborators":26,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":26,"enrollmentInfo":77,"targetDuration":26,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Institut du Cancer de Montpellier - Val d'Aurelle","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort A : Experimental group","EXPERIMENTAL","In cohort A, for patients with high and undetermined risk of fibrosis (bf+), an adaptive BC RT (ETHOS) will be delivered.",[13],"Radiation: Treatment ETHOS radiotherapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Cohort B : Control group","ACTIVE_COMPARATOR","In cohort B, for patients with low risk of fibrosis (bf-), an IMRT will be delivered.",[19],"Radiation: Conventional IMRT",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"RADIATION","Treatment ETHOS radiotherapy","• Cohort A: Adaptive RT: PTV = CTV + 2 mm (except for IMC with 5mm), excluding 5mm beneath the skin",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Conventional IMRT","• Cohort B: IMRT: PTV = CTV + 7mm, excluding 5mm beneath the skin",[15],[32,35],{"name":33,"affiliation":5,"role":34},"BOURGIER CELINE","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":37,"role":34},"ARNAUD ANTOINE","INSTITUT SAINTE CATHERINE \u002F AVIGNON",[39],{"name":40,"role":41,"phone":42,"phoneExt":26,"email":43},"MOUSSION AURORE","CONTACT","0467613102","aurore.moussion@icm.unicancer.fr",[45],{"facility":46,"status":47,"city":48,"state":26,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle","RECRUITING","Montpellier","34298","France","FR",{"type":53,"coordinates":54},"Point",[55,56],3.87635,43.61093,{"lat":56,"lon":55},[59,63],{"name":60,"role":41,"phone":61,"phoneExt":26,"email":62},"Marc Ychou, MD, PhD","33-4-6761-3066","marc.ychou@icm.unicancer.fr",{"name":64,"role":41,"phone":42,"phoneExt":26,"email":43},"Aurore MOUSSION",{"type":66,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100520170","sahara-04--adaptive-radiotherapy-in-hypersensitive-patients-and-high-locoregional-risk-breast-cancer-with-ethos-technology-100520170",false,"NCT06053086","SAHARA-04 : Adaptive Radiotherapy in Hypersensitive Patients and High Locoregional Risk Breast Cancer With ETHOS Technology","Adaptive Radiotherapy in Hypersensitive Patients and High Locoregional Risk Breast Cancer With ETHOS Technology","SAHARA-04","Inclusion Criteria:\n\n* Women ≥ 18 years old.\n* Conservative breast cancer surgery or radical mastectomy.\n* At least pN1 breast cancers, regardless breast cancer subtypes.\n* Tumor negative margins.\n* Indication of whole breast and node irradiation.\n* Extension evaluation of disease will be proven negative (M0).\n* Risk level of breast fibrosis identified by the centralized NovaGray RILA Breast® test\n* Must be geographically accessible for follow-up.\n* Written and dated informed consent.\n* Affiliated to the French national social security system.\n\nExclusion Criteria:\n\n* Patients with distant metastases.\n* Bilateral breast cancer (concomitant or prior) except in situ lesion, either ductal or lobular, of the contralateral breast.\n* Patients with previous or concomitant other (not breast cancer) malignancy within the past 5 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who have had a previous other malignancy must have been disease free for at least five years.\n* Patients with other non-malignant systemic diseases (cardiovascular, renal, hepatic, lung embolism, etc.) which would prevent prolonged follow-up.\n* Patients treated with systemic investigational drugs within the past 30 days (Observational cohorts are accepted if the collection of data does not interfere with the current trial)\n* Untreated hypothyroidism\n* Patients known to be HIV positive (no specific tests are required to determine the eligibility).\n* Patients known as hypersensitive to radiation (ATM Homozygote, p53-\u002F-,…)\n* Pregnant or breast-feeding women\n* Patient unable to comply with study obligations for geographic, social, or physical reasons, or who is unable to understand the purpose and procedures of the study\n* Person deprived of their liberty or under protective custody or guardianship.","FEMALE","18 Years",{"count":78,"type":79},500,"ESTIMATED","INTERVENTIONAL",[82],"NA","* Prospective, open-label, bi-center study, assessing the clinical outcomes of adaptive breast radiotherapy with ETHOS in hypersensitive patients.\n* Bi-centric with ETHOS center : ICM (Institut du Cancer de Montpellier) and ISC (Institut Sainte Catherine) Avignon\n* 500 patients will be included:\n* COHORTE A = Treatment ETHOS RT :46 evaluable patients with high risk of LRR and bf+ risk\n* COHORT B = Conventional IMRT : 454 others patients with high risk of LRR and bf- risk",[85],"Breast Cancer",[87,88,89,90],"radiotherapy","breast cancer","cancer","ETHOS","2026-03-10",{"date":93,"type":94},"2026-03-12","ACTUAL",{"date":96,"type":94},"2025-03-01",{"date":98,"type":79},"2030-11-30",{"name":5,"class":6},1]