[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594622":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":27,"studyPopulation":20,"armGroups":28,"interventions":35,"overallOfficials":20,"centralContacts":41,"locations":47,"responsibleParty":63,"collaborators":20,"id":65,"slug":20,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":20,"studyType":78,"phases":79,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":50,"whyStopped":20,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Campus Bio-Medico","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Breast fibrosis","Rate of all grades breast fibrosis evaluated by means of Common Terminology Criteria for Adverse Events (CTCAE) v. 5 scale","baseline, each year up to 4 years after radiotherapy",[14,17],{"measure":15,"description":16,"timeFrame":12},"Breast cosmesis","Rate of fair and poor cosmesis evaluated by means of European Organisation for Research and Treatment of Cancer (EORTC) Cosmetic Rating System for Breast Cancer",{"measure":18,"description":19,"timeFrame":12},"Quality of Life (QOL)","Quality of Life evaluated by means of European Organization for Research and Treatment-QOL questionnaire (EORTC QLQ-C30)",null,{"allocation":22,"interventionModel":23,"interventionModelDescription":20,"primaryPurpose":24,"observationalModel":20,"timePerspective":20,"maskingInfo":25},"NA","SINGLE_GROUP","TREATMENT",{"masking":26,"maskingDescription":20,"whoMasked":20},"NONE","This is a prospective, single-arm, phase II, non-randomized clinical trial that will test an hypofractionated schedule with high dose simultaneous integrated tumor bed boost set on a previous dose finding study. Patients will be treated with hypofractionated 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). The study population will include early breast cancer patients with younger age (\\\u003C or= 50 years) and additional risk factors for local recurrence.\n\nThe primary objective of the study is to evaluate the rate of radiation-induced fibrosis at 4 years.The expected enrollment is 132 patients in 6 years. Each patient must have a minimum follow-up of 4 years.\n\nThe secondary objective is to evaluate cosmesis; other objectives are to evaluate quality of life (QoL) and the rate of local control.",[29],{"label":30,"type":31,"description":32,"interventionNames":33},"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).",[34],"Radiation: hypofractionated radiotherapy with tumor bed boost",[36],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":20},"RADIATION","hypofractionated radiotherapy with tumor bed boost","hypofractionated radiotherapy with concomitant\u002Fsimultaneous tumor bed boost",[30],[42],{"name":43,"role":44,"phone":45,"phoneExt":20,"email":46},"Edy Ippolito, Prof","CONTACT","+3906225418081","e.ippolito@unicampus.it",[48],{"facility":49,"status":50,"city":51,"state":20,"zip":20,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Università Campus Biomedico","RECRUITING","Roma","Italy","IT",{"type":55,"coordinates":56},"Point",[57,58],11.10642,44.99364,{"lat":58,"lon":57},[61],{"name":62,"role":44,"phone":20,"phoneExt":20,"email":20},"Sara Ramella, Prof",{"type":64,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","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":76,"type":77},132,"ESTIMATED","INTERVENTIONAL",[22],"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)",[82],"Breast Cancer",[84,85,86],"tumor bed boost","radiotherapy","hypofractionation","2025-06-11",{"date":89,"type":90},"2025-06-15","ACTUAL",{"date":92,"type":90},"2020-03-12",{"date":94,"type":77},"2030-03",{"name":5,"class":6},1]