[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598126":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":45,"studyPopulation":16,"armGroups":46,"interventions":53,"overallOfficials":59,"centralContacts":64,"locations":70,"responsibleParty":373,"collaborators":16,"id":376,"slug":16,"hasResults":377,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":381,"eligibilityCriteria":382,"healthyVolunteers":377,"sex":383,"minAge":384,"maxAge":16,"enrollmentInfo":385,"targetDuration":16,"studyType":388,"phases":389,"briefSummary":390,"conditions":391,"keywords":393,"overallStatus":183,"whyStopped":16,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":405},{"fullName":5,"class":6},"National Institute of Oncology, Hungary","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"Five-year incidence of late grade ≥ 2 side effects","Radiation side effects based on Common Terminology Criteria for Adverse Events (CTCAE) (grade 1 to grade 5, higher score worse); and with the Radiation Therapy Oncology Group \u002F European Organization for Research and Treatment of Cancer (RTOG\u002FEORTC) Late Radiation Morbidity Scoring Schema (grade 1 to grade 4, higher score worse).","From the third month of treatment to the end of the fifth year of follow-up.",[14,18,20,22,24,26,28,30,33,36],{"measure":15,"description":16,"timeFrame":17},"Incidence (5-year actuarial rate) of ipsilateral breast recurrence (IBR)",null,"From treatment to the end of the fifth year of follow-up.",{"measure":19,"description":16,"timeFrame":17},"Incidence (5-year actuarial rate) of regional relapse (RR)",{"measure":21,"description":16,"timeFrame":17},"Incidence (5-year actuarial rate) of contralateral breast cancer (CBC)",{"measure":23,"description":16,"timeFrame":17},"Incidence (5-year actuarial rate) of distant metastasis (DM)",{"measure":25,"description":16,"timeFrame":17},"Incidence (5-year actuarial rate) of any relapse (local, regional or distant, whichever came first) for disease free survival (DFS)",{"measure":27,"description":16,"timeFrame":17},"Incidence (5-year actuarial rate) of breast cancer death for cause specific survival (CSS)",{"measure":29,"description":16,"timeFrame":17},"Incidence (5-year actuarial rate) of death by any cause for overall survival (OS)",{"measure":31,"description":11,"timeFrame":32},"Incidence of acute side effects","From treatment to the end of the first 3 months of follow-up.",{"measure":34,"description":35,"timeFrame":17},"Cosmetic results at 5 years","Cosmetic results based on the Harvard criteria (excellent, good, fair, poor).",{"measure":37,"description":38,"timeFrame":17},"Quality of Life (QoL)","European Organisation For Research And Treatment Of Cancer (EORTC) Quality of Life questionnaire (QLQ) C30 questionaire including the Breast cancer module (QLQ-BR23) (53 questions in total, from 1 to 4 points, higher score worse)",{"allocation":40,"interventionModel":41,"interventionModelDescription":16,"primaryPurpose":42,"observationalModel":16,"timePerspective":16,"maskingInfo":43},"NA","SINGLE_GROUP","TREATMENT",{"masking":44,"maskingDescription":16,"whoMasked":16},"NONE","Accelerated Partial Breast Irradiation (APBI) has demonstrated the non-inferiority compared to external beam radiotherapy (EBRT) in the conserving-treatment of early breast carcinoma by using high-dose-rate (HDR) multicatheter interstitial brachytherapy (MIBT). The standard treatment regimen is 7-8 sessions with two treatments per day, for a total treatment time of 4-5 days. Based on 5-year results of the Groupe Européen de Curiethérapie European SocieTy for Radiotherapy \\& Oncology (GEC-ESTRO) Very Accelerated Partial Breast Irradiation (VAPBI) phase I-II trial, in low-risk cases, 3-4 fractions delivered in 2 days reduced the overall treatment time with low rate of side effects and excellent oncological outcome.\n\nRetrospective and prospective studies with a single fraction HDR MIBT-based VAPBI suggest that by further increasing the dose delivered in one fraction, the total treatment time can be reduced to a single session safely.\n\nA phase II multicenter trial is proposed to confirm this hypothesis.",[47],{"label":48,"type":49,"description":50,"interventionNames":51},"single-fraction very accelerated partial breast irradiation arm","EXPERIMENTAL","Low risk, early-stage breast cancer patients, who receiving single-fraction very accelerated partial breast irradiation, as postoperative radiation therapy.",[52],"Radiation: single-fraction very accelerated partial breast irradiation",[54],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":16},"RADIATION","single-fraction very accelerated partial breast irradiation","Adjuvant accelerated partial breast brachytherapy, with interstitial multicatheter technique, in one fraction.",[48],[60],{"name":61,"affiliation":62,"role":63},"Viktor Smanykó, MD","National Institute of Oncology, Budapest, Hungary","PRINCIPAL_INVESTIGATOR",[65],{"name":61,"role":66,"phone":67,"phoneExt":68,"email":69},"CONTACT","+3612248600","3440","smanyko.viktor@oncol.hu",[71,88,101,114,129,142,155,168,181,196,211,226,239,251,264,277,292,307,322,332,345,358],{"facility":72,"status":73,"city":74,"state":16,"zip":16,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Centre Léon 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Erlangen","Erlangen",{"type":78,"coordinates":133},[134,135],11.00783,49.59099,{"lat":135,"lon":134},[138,141],{"name":139,"role":66,"phone":16,"phoneExt":16,"email":140},"Vratislav Strnad, MD","Vratislav.Strnad@uk-erlangen.de",{"name":139,"role":63,"phone":16,"phoneExt":16,"email":16},{"facility":143,"status":73,"city":144,"state":16,"zip":16,"country":117,"countryCode":118,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"Universitätsklinikum Schleswig-Holstein","Lübeck",{"type":78,"coordinates":146},[147,148],10.68729,53.86893,{"lat":148,"lon":147},[151,154],{"name":152,"role":66,"phone":16,"phoneExt":16,"email":153},"Tamer Soror, MD","tamer.soror@uksh.de",{"name":152,"role":63,"phone":16,"phoneExt":16,"email":16},{"facility":156,"status":73,"city":157,"state":16,"zip":16,"country":117,"countryCode":118,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"Sana Klinikum 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Oncology","RECRUITING","Budapest","Hungary","HU",{"type":78,"coordinates":188},[189,190],19.04045,47.49835,{"lat":190,"lon":189},[193,195],{"name":194,"role":66,"phone":67,"phoneExt":16,"email":69},"Smanykó Viktor, MD",{"name":61,"role":63,"phone":16,"phoneExt":16,"email":16},{"facility":197,"status":73,"city":198,"state":16,"zip":16,"country":199,"countryCode":200,"cosmosGeoPoint":201,"geoPoint":205,"contacts":206},"National Cancer Institute","Vilnius","Lithuania","LT",{"type":78,"coordinates":202},[203,204],25.2798,54.68916,{"lat":204,"lon":203},[207,210],{"name":208,"role":66,"phone":16,"phoneExt":16,"email":209},"Justinas Jonusas, MD","justinas.jonusas@nvi.lt",{"name":208,"role":63,"phone":16,"phoneExt":16,"email":16},{"facility":212,"status":73,"city":213,"state":16,"zip":16,"country":214,"countryCode":215,"cosmosGeoPoint":216,"geoPoint":220,"contacts":221},"Maria Skłodowska-Curie Bialystok Oncology Center","Bialystok","Poland","PL",{"type":78,"coordinates":217},[218,219],23.16433,53.13333,{"lat":219,"lon":218},[222,225],{"name":223,"role":66,"phone":16,"phoneExt":16,"email":224},"Dorota Kazberuk, MD","d.kazberuk@onet.pl",{"name":223,"role":63,"phone":16,"phoneExt":16,"email":16},{"facility":227,"status":73,"city":228,"state":16,"zip":16,"country":214,"countryCode":215,"cosmosGeoPoint":229,"geoPoint":233,"contacts":234},"Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny","Brzozów",{"type":78,"coordinates":230},[231,232],22.01926,49.69501,{"lat":232,"lon":231},[235,238],{"name":236,"role":66,"phone":16,"phoneExt":16,"email":237},"Damian Kazalski, 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MD","kristina.loessl@insel.ch",{"name":370,"role":63,"phone":16,"phoneExt":16,"email":16},{"type":63,"investigatorFullName":374,"investigatorTitle":375,"investigatorAffiliation":5,"oldNameTitle":16,"oldOrganization":16},"Viktor Smanykó, MD, PhD","chief physician","100598126",false,"NCT07067437","Single-Fraction Very Accelerated Partial Breast Irradiation (sfVAPBI)","Single-Fraction Very Accelerated Partial Breast Irradiation (sfVAPBI) in Low-Risk Invasive or Ductal In Situ Breast Carcinoma - Phase II Multicenter Trial","sfVAPBI","Inclusion Criteria:\n\n* Stage 0 \\& I \\& II (\\\u003C 3 cm) breast carcinoma\n* Lesions of \\\u003C 3 cm diameter\n* Invasive carcinoma of any subtype and grade or ductal carcinoma in situ (DCIS)\n* Nodal status: node-negative (pN0) or micro-metastatic (pN1mi) (patients with pN1mi status can be treated, but due to the limited clinical evidence, individual decision is needed)\n* M0: Absence of distant metastasis\n* Clear resection margins by National Surgical Adjuvant Breast and Bowel Project (NSABP) definition (no tumor on ink)\n* Unifocal (multifocality limited within 2 cm) and unicentric breast cancer\n* Age\\> 40 years\n* Luminal A or B tumors\n* Time interval from surgery preferably less than 12 weeks and no longer than 20 weeks, and from adjuvant chemotherapy less than 4 weeks\n* Human Epidermal growth factor Receptor 2 positive (HER2+) patients receiving postoperative anti-HER2 systemic therapy\n* Specific signed consent form prior to randomization\n\nExclusion Criteria:\n\n* Stage III-IV breast cancer\n* Surgical margins that cannot be microscopically assessed\n* Extensive intraductal component (EIC+)\n* Extensive lymphovascular invasion (LVI+) (focal is allowed)\n* Triple negative breast cancer\n* BReast CAncer gene (BRCA) 1-2 mutation\n* Human Epidermal growth factor Receptor 2 positive (HER2+) patients not receiving postoperative anti-HER2 systemic therapy\n* Neoadjuvant systemic therapy\n* Paget's disease or pathological skin involvement\n* Synchronous or previous breast cancer.\n* Pregnant or lactating women","FEMALE","40 Years",{"count":386,"type":387},250,"ESTIMATED","INTERVENTIONAL",[40],"To investigate clinical outcomes, late side effects, and cosmetic results of a single-fraction very accelerated partial breast irradiation as postoperative local treatment for the treatment of early stage breast cancer.",[392],"Breast Neoplasms",[394,395],"breast cancer","brachytherapy","2025-07-05",{"date":398,"type":399},"2025-07-16","ACTUAL",{"date":401,"type":399},"2025-07-01",{"date":403,"type":387},"2032-08-01",{"name":5,"class":6},22]