[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550854":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":26,"centralContacts":31,"locations":39,"responsibleParty":53,"collaborators":56,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":10,"enrollmentInfo":73,"targetDuration":10,"studyType":76,"phases":10,"briefSummary":77,"conditions":78,"keywords":83,"overallStatus":41,"whyStopped":10,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Amsterdam UMC, location VUmc","OTHER",[8,14,18],{"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],{"label":19,"type":10,"description":20,"interventionNames":10},"surgery only","Patients who do not receive postoperative re-irradiation after salvage mastectomy.",[22],{"type":6,"name":23,"description":24,"armGroupLabels":25,"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],[27],{"name":28,"affiliation":29,"role":30},"Desiree Van Den Bongard, Dr","Amsterdam UMC","PRINCIPAL_INVESTIGATOR",[32,37],{"name":33,"role":34,"phone":35,"phoneExt":10,"email":36},"Lisca Wurfbain, MD","CONTACT","+31 6-25414750","l.f.wurfbain@amsterdamumc.nl",{"name":28,"role":34,"phone":35,"phoneExt":10,"email":38},"h.j.vandenbongard@amsterdamumc.nl",[40],{"facility":29,"status":41,"city":42,"state":10,"zip":10,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Amsterdam","Netherlands","NL",{"type":46,"coordinates":47},"Point",[48,49],4.88969,52.37403,{"lat":49,"lon":48},[52],{"name":33,"role":34,"phone":10,"phoneExt":10,"email":36},{"type":30,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Desiree H.J.G.D. van den Bongard, MD Ph","Dr",[57,60,62],{"name":58,"class":59},"Borstkanker Onderzoek Groep","NETWORK",{"name":61,"class":6},"Comprehensive Cancer Centre The Netherlands",{"name":63,"class":6},"Dutch Cancer Society","100550854","postoperative-re-irradiation-with-and-without-hyperthermia-or-surgery-only-toxicity-quality-of-life-and-survival-in-patients-with-locoregional-recurrent-breast-cancer-100550854",false,"NCT06452485","Postoperative Re-irradiaTion With and Without HYPERthermia, or Surgery Only: Toxicity, Quality of Life and Survival in Patients With Locoregional Recurrent Breast Cancer","RT-HYPE","Inclusion criteria:\n\n* ≥ 18 years old\n* WHO performance scale ≤ 2\n* Diagnosed with local +\u002F- regional recurrence (LRR) (i.e. true recurrence or second primary) with high-risk tumor characteristics\\* and previously treated with postoperative local +\u002F- regional irradiation for primary breast cancer\u002Fprevious recurrence with an indication for salvage mastectomy with\u002Fwithout postoperative re-irradiation (+\u002F-hyperthermia)\\*\\* if re-irradiation: including overlap of re-irradiated volume with previous irradiated volume\n* Diagnosed with a chest wall recurrence and treated with local excision with\u002Fwithout NAST and postoperative re irradiation with\u002Fwithout hyperthermia. In patients with a clinical\u002Fradiological complete response after neoadjuvant systemic treatment, NO surgery and re irradiation (+\u002F- hyperthermia) (since surgery is not possible in this group)\n* (Neo-)adjuvant systemic (NAST) treatment is allowed\n* Use of PET(FES\u002FFDG)-CT for 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* Proficient in Dutch at a level allowing to understand the questionnaires and patient information sheet\n\n  \\* Definition of high-risk tumor characteristics are:\n* (Focal) irradical resection\n* All clinical and pathological stages except for low-risk LRR: - rcT1-2N0 - r(y)pT1-2N0 \\*\\* according to local clinical practice and\u002For shared decision making process\n\nExclusion criteria:\n\n• Diagnosed with primary breast sarcoma","ALL","18 Years",{"count":74,"type":75},500,"ESTIMATED","OBSERVATIONAL","In the Netherlands, breast cancer patients with locoregional recurrence (LRR) and intermediate- and high-risk factors are treated with surgery with or without 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 in high-risk LRR patients.",[79,80,81,82],"Locoregional Recurrence","Breast Cancer","Re-irradiation","Hyperthermia",[84],"locoregional recurrence, breast cancer, treatment, re-irradiation, hyperthermia, patient-reported outcomes, quality of life, toxicity","2026-07-14",{"date":87,"type":88},"2026-07-16","ACTUAL",{"date":90,"type":88},"2024-02-01",{"date":92,"type":75},"2027-10",{"name":5,"class":6},1]