[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550854":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":28,"locations":36,"responsibleParty":50,"collaborators":53,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":10,"enrollmentInfo":70,"targetDuration":10,"studyType":73,"phases":10,"briefSummary":74,"conditions":75,"keywords":10,"overallStatus":38,"whyStopped":10,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Amsterdam UMC, location VUmc","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Postoperative re-irradiation with hyperthermia",null,"Postoperative re-irradiation with hyperthermia in patients with locoregional recurrent breast cancer",[13],"Other: No interventions, patient-reported outcomes (PROMs) and toxicity will be collected in both groups.",{"label":15,"type":10,"description":16,"interventionNames":17},"Postoperative re-irradiation without hyperthermia","Postoperative re-irradiation without hyperthermia in patients with locoregional recurrent breast cancer",[13],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"No interventions, patient-reported outcomes (PROMs) and toxicity will be collected in both groups.","Patients will receive standard of care. Patients need to fill in questionnaires, these are additional interventions for the included subject. Questionnaires for patient-reported outcomes (PROMs) and toxicity will be filled in one week before treatment, one week before re-irradiation, one week and three months after re-irradiation, one, two and five years after surgery.",[9,15],[24],{"name":25,"affiliation":26,"role":27},"Desiree Van Den Bongard, Dr","Amsterdam UMC","PRINCIPAL_INVESTIGATOR",[29,34],{"name":30,"role":31,"phone":32,"phoneExt":10,"email":33},"Lisca Wurfbain, MD","CONTACT","+31 6-25414750","l.f.wurfbain@amsterdamumc.nl",{"name":25,"role":31,"phone":32,"phoneExt":10,"email":35},"h.j.vandenbongard@amsterdamumc.nl",[37],{"facility":26,"status":38,"city":39,"state":10,"zip":10,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"RECRUITING","Amsterdam","Netherlands","NL",{"type":43,"coordinates":44},"Point",[45,46],4.88969,52.37403,{"lat":46,"lon":45},[49],{"name":30,"role":31,"phone":10,"phoneExt":10,"email":33},{"type":27,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Desiree H.J.G.D. van den Bongard, MD Ph","Dr",[54,57,59],{"name":55,"class":56},"Borstkanker Onderzoek Groep","NETWORK",{"name":58,"class":6},"Comprehensive Cancer Centre The Netherlands",{"name":60,"class":6},"Dutch Cancer Society","100550854","postoperative-re-irradiation-with-and-without-hyperthermia-toxicity-quality-of-life-and-survival-in-patients-with-locoregional-recurrent-breast-cancer-100550854",false,"NCT06452485","Postoperative Re-irradiaTion With and Without HYPERthermia: Toxicity, Quality of Life and Survival in Patients With Locoregional Recurrent Breast Cancer","RT-HYPE","Inclusion Criteria:\n\n* WHO performance scale ≤2\n* \\>=18 years\n* Patients with a LRR breast cancer after postoperative irradiation of the primary breast cancer. LRR is defined as a local and\u002For regional recurrence, including patients with a second primary ipsilateral breast cancer.\n* Patients treated with salvage mastectomy with high-risk\\* tumor characteristics or local excision with an indication for postoperative re-irradiation.\n* Previously treated with whole or partial breast irradiation.\n* (Neo)adjuvant systemic therapy (NST) is allowed.\n* Use of (FES\u002FFDG-)PET-CT in staging of nodal and disseminated disease.\n* Oligometastases in lymph nodes in the mediastinum, neck, contralateral axillary\u002Fsupraclavicular region (up to a maximal number of five) is allowed.\n* Adequate communication and understanding skills of the Dutch language.\n\nExclusion Criteria:\n\n* Diagnosed with primary breast sarcoma\n* Have a low-risk LRR after previous breast-conserving surgery\u002Ftherapy","ALL","18 Years",{"count":71,"type":72},500,"ESTIMATED","OBSERVATIONAL","In the Netherlands, breast cancer patients with locoregional recurrence (LRR) and high-risk factors are treated with postoperative re-irradiation with or without hyperthermia. Retrospective studies showed that 3-year locoregional control after postoperative re-irradiation with hyperthermia was 68-83%, and severe toxicity in up to 40% of LRR patients. Unfortunately, no prospective (randomized) data are available on clinical outcomes. Consequently, variation exists in hyperthermia-treatment and re-irradiation schedules. Prospective real-world data on oncological outcomes, toxicity and quality of life is highly needed for shared decision-making between patients and professionals. These data will be used in the design of a future randomized trial comparing postoperative re-irradiation and hyperthermia-treatment in high-risk LRR patients.",[76,77,78,79],"Locoregional Recurrence","Breast Cancer","Re-irradiation","Hyperthermia","2025-09-30",{"date":82,"type":83},"2025-10-06","ACTUAL",{"date":85,"type":83},"2024-01-01",{"date":87,"type":72},"2027-05",{"name":5,"class":6},1]