[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594622":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":43,"collaborators":20,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":47,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":20,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Campus Bio-Medico","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Hypofractionated arm + concomitant tumor bed boost","EXPERIMENTAL","Hypofractionation arm, 40 Gy in 15 fractions (2.67 Gy per fraction over 3 weeks) and a tumor bed boost to a total dose of 52.5 Gy in 15 fractions (3.5 Gy per fraction over 3 weeks).",[13],"Radiation: hypofractionated radiotherapy with tumor bed boost",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"RADIATION","hypofractionated radiotherapy with tumor bed boost","hypofractionated radiotherapy with concomitant\u002Fsimultaneous tumor bed boost",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Edy Ippolito, Prof","CONTACT","+3906225418081","e.ippolito@unicampus.it",[28],{"facility":29,"status":30,"city":31,"state":20,"zip":20,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Università Campus Biomedico","RECRUITING","Roma","Italy","IT",{"type":35,"coordinates":36},"Point",[37,38],11.10642,44.99364,{"lat":38,"lon":37},[41],{"name":42,"role":24,"phone":20,"phoneExt":20,"email":20},"Sara Ramella, Prof",{"type":44,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100594622","dose-escalated-concomitant-boost-radiotherapy-for-early-breast-cancer-100594622",false,"NCT07021846","Dose Escalated Concomitant Boost Radiotherapy for Early Breast Cancer","Hypofractionated Radiotherapy With Dose Escalated Concomitant Boost for Breast Cancer: a Phase 2 Trial","DEBoRa","Inclusion Criteria:\n\n* histologically proven breast cancer who have undergone conservative surgery\n* at least 3 inserted clips\n* age: from 18 years old to 50 years\n* at least one of the following risk factors: N1 disease, LVI, extensive intraductal component (\\>25%), close margins (\\\u003C4 mm), non-hormone-sensitive disease, grading 3\n* ECOG performance status \\\u003C 2\n* adequate bone marrow (haemoglobin concentration \\> 8 g\u002Fdl, white blood cell count \\> 3000\u002Fmm3, platelet count \\> 75000).\n\nExclusion Criteria:\n\n* Previous chest radiation treatment\n* Bilateral breast cancer\n* Neoadjuvant chemotherapy\n* BMI \\> 35\n* Collagen diseases\n* Pregnancy or breastfeeding","FEMALE","18 Years","50 Years",{"count":57,"type":58},132,"ESTIMATED","INTERVENTIONAL",[61],"NA","The goal of this prospective, single-arm, phase II, non-randomized trial is to evaluate an hypofractionation schedule with high dose simultaneous integrated tumor bed boost in early breast cancer patients.\n\nThe main question\\[s\\] it aims to answer are:\n\n* evaluate the rate of all grades of radiation-induced fibrosis at 4 years.\n* evaluate poor\u002Ffair cosmesis rate Participants will be treated with hypofractionated radiotherapy (RT) to whole breast with a dose of 40.05 Gy in 15 fractions (2.67 Gy\u002Fdie) and a concomitant tumor bed dose of 52.5 Gy (3.5 gy\u002Fdie)",[64],"Breast Cancer",[66,67,68],"tumor bed boost","radiotherapy","hypofractionation","2025-06-11",{"date":71,"type":72},"2025-06-15","ACTUAL",{"date":74,"type":72},"2020-03-12",{"date":76,"type":58},"2030-03",{"name":5,"class":6},1]