[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100509546":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":38,"responsibleParty":55,"collaborators":11,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":11,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":11,"enrollmentInfo":67,"targetDuration":11,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":40,"whyStopped":11,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Oncology Institute of Vojvodina","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Partial Breast Irradiation","ACTIVE_COMPARATOR",null,[13],"Radiation: Ultra-fractionated PBI",{"label":15,"type":16,"description":11,"interventionNames":17},"Whole Breast Irradiation","EXPERIMENTAL",[18],"Radiation: Ultra-fractionated WBI",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"RADIATION","Ultra-fractionated WBI","An ultra-short course of radiotherapy with 26Gy in 5 fractions will be administered to the whole breast where the tumor was located.",[15],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Ultra-fractionated PBI","An ultra-short course of radiotherapy with 26Gy in 5 fractions will be administered to the part of the breast where the tumor was located.",[9],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Olivera Ivanov","CONTACT","0214805496","ivanov.olivera@onk.ns.ac.rs",{"name":36,"role":32,"phone":11,"phoneExt":11,"email":37},"Marko Bojovic","bojovic.marko@onk.ns.ac.rs",[39],{"facility":5,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Novi Sad","Vojvodina","21204","Serbia","RS",{"type":47,"coordinates":48},"Point",[49,50],19.83694,45.25167,{"lat":50,"lon":49},[53,54],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},{"name":36,"role":32,"phone":11,"phoneExt":11,"email":37},{"type":56,"investigatorFullName":36,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Ass. MD","100509546","phase-2-ultra-hypofractionated-for-whole-breast-irradiation-wbi-compared-to-partial-breast-irradiation-pbi-100509546",false,"NCT05914831","Ultra-hypofractionated for Whole Breast Irradiation (WBI) Compared to Partial Breast Irradiation (PBI)","Ultra-hypofractionated for Whole Breast Irradiation (WBI) Compared to Partial Breast Irradiation (PBI): A Single-Institution Prospective Phase 2 Trial","Inclusion Criteria:\n\n* Breast-conserving surgery\n* Invasive ductal carcinoma\n* Age ≥ 50\n* Tumor size ≤ 3 cm\n* R0 resection\n* Unicentric\u002Funifocal carcinoma or multifocal carcinoma within 2 cm of the primary neoplasm\n* pN0 (sentinel lymph node biopsy or axillary lymph node dissection performed), N1mi\n* Hormone receptor status - any\n* Histological grade G1 or G2\n\nExclusion Criteria:\n\n* Neoadjuvant systemic therapy\n* TNBC (triple-negative breast cancer)\n* Extensive intraductal component (EIC)\n* Lymphovascular invasion (LVI)\n* associated DCIS \\> 2.5 cm in size or high nuclear grade","FEMALE","50 Years",{"count":68,"type":69},100,"ESTIMATED","INTERVENTIONAL",[72],"PHASE2","Female patients undergoing surgical treatment for early breast cancer and meeting the inclusion criteria for adjuvant breast radiotherapy were randomized into two groups. One group will receive adjuvant whole-breast radiotherapy in ultra-hypofractionated regimen of 26 Gy in 5 fractions. In contrast, the other group will receive partial breast irradiation with a dose of 26Gy in 5 fractions.\n\nThe study's objective is to compare the effects of both breast radiotherapy protocols in terms of locoregional disease control and survival and to compare the adverse effects of radiotherapy between the two protocols. To determine if there is a correlation between different parameters and the efficacy and degree of toxicity for both protocols.",[75],"Breast Cancer Female",[77,78,79],"Ultra-hypofractionated radiotherapy","Partial breast irradiation","Breast radiotherapy toxicity","2023-06-28",{"date":82,"type":83},"2023-07-03","ACTUAL",{"date":85,"type":83},"2023-06-01",{"date":87,"type":69},"2033-05-31",{"name":5,"class":6},1]