[{"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":384,"collaborators":16,"id":387,"slug":388,"hasResults":389,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":393,"eligibilityCriteria":394,"healthyVolunteers":389,"sex":395,"minAge":396,"maxAge":16,"enrollmentInfo":397,"targetDuration":16,"studyType":400,"phases":401,"briefSummary":402,"conditions":403,"keywords":405,"overallStatus":103,"whyStopped":16,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":417},{"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 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Erlangen","Erlangen",{"type":78,"coordinates":134},[135,136],11.00783,49.59099,{"lat":136,"lon":135},[139,142],{"name":140,"role":66,"phone":16,"phoneExt":16,"email":141},"Vratislav Strnad, MD","Vratislav.Strnad@uk-erlangen.de",{"name":140,"role":63,"phone":16,"phoneExt":16,"email":16},{"facility":144,"status":73,"city":145,"state":16,"zip":16,"country":118,"countryCode":119,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Universitätsklinikum Schleswig-Holstein","Lübeck",{"type":78,"coordinates":147},[148,149],10.68729,53.86893,{"lat":149,"lon":148},[152,155],{"name":153,"role":66,"phone":16,"phoneExt":16,"email":154},"Tamer Soror, MD","tamer.soror@uksh.de",{"name":153,"role":63,"phone":16,"phoneExt":16,"email":16},{"facility":157,"status":73,"city":158,"state":16,"zip":16,"country":118,"countryCode":119,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"Sana Klinikum 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00","cristina.gutierrez@hmar.cat",{"facility":324,"status":73,"city":309,"state":16,"zip":16,"country":311,"countryCode":312,"cosmosGeoPoint":325,"geoPoint":327,"contacts":328},"Fundacion IMOR's Oncology Clinic",{"type":78,"coordinates":326},[315,316],{"lat":316,"lon":315},[329,332],{"name":330,"role":66,"phone":16,"phoneExt":16,"email":331},"Benjamin Guix, MD","drguix@icloud.com",{"name":330,"role":63,"phone":16,"phoneExt":16,"email":16},{"facility":334,"status":103,"city":309,"state":16,"zip":16,"country":311,"countryCode":312,"cosmosGeoPoint":335,"geoPoint":337,"contacts":338},"Institut Catala d'Oncologia",{"type":78,"coordinates":336},[315,316],{"lat":316,"lon":315},[339,342],{"name":340,"role":66,"phone":16,"phoneExt":16,"email":341},"Cristina Gutierrez-Miguelez, 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MD","jguinot@fivo.org",{"name":366,"role":63,"phone":16,"phoneExt":16,"email":16},{"facility":370,"status":73,"city":371,"state":16,"zip":16,"country":372,"countryCode":373,"cosmosGeoPoint":374,"geoPoint":378,"contacts":379},"Inselspital, Universitätsspital Bern","Bern","Switzerland","CH",{"type":78,"coordinates":375},[376,377],7.44744,46.94809,{"lat":377,"lon":376},[380,383],{"name":381,"role":66,"phone":16,"phoneExt":16,"email":382},"Kristina Lössl, MD","kristina.loessl@insel.ch",{"name":381,"role":63,"phone":16,"phoneExt":16,"email":16},{"type":63,"investigatorFullName":385,"investigatorTitle":386,"investigatorAffiliation":5,"oldNameTitle":16,"oldOrganization":16},"Viktor Smanykó, MD, PhD","chief physician","100598126","single-fraction-very-accelerated-partial-breast-irradiation-sfvapbi-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":398,"type":399},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.",[404],"Breast Neoplasms",[406,407],"breast cancer","brachytherapy","2026-09-05",{"date":410,"type":411},"2026-09-09","ACTUAL",{"date":413,"type":411},"2025-07-01",{"date":415,"type":399},"2032-08-01",{"name":5,"class":6},23]