[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"re-irradiation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:re-irradiation":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"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":19,"type":20},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.",[24,25,26,27],"Locoregional Recurrence","Breast Cancer","Re-irradiation","Hyperthermia",[29],"locoregional recurrence, breast cancer, treatment, re-irradiation, hyperthermia, patient-reported outcomes, quality of life, toxicity","RECRUITING","2026-07-14",{"date":33,"type":34},"2026-07-16","ACTUAL",{"date":36,"type":34},"2024-02-01",{"date":38,"type":20},"2027-10",{"name":40,"class":41},"Amsterdam UMC, location VUmc","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100567426","contribution-of-multicenter-expertise-and-deformable-fusion-software-for-re-irradiations-with-curative-intent-100567426","NCT06668038","Contribution of Multicenter Expertise and Deformable Fusion Software for Re-irradiations With Curative Intent","Evaluation of the Contribution of Multicenter Expertise (Radiotherapists and Physicists) and Use of Deformable Fusion Software Allowing the Accumulation of Doses in Equivalent Dose 2 Grays for Re-irradiations With Curative Intent","ADERE","Inclusion Criteria:\n\n* Age ≥ 18 years when signing the consent form\n* Re-irradiation with desired curative intent (≥ 50 Gy EQD2), with volume to be irradiated totally or partially included in a previous irradiation field:\n\n  * Oligo-metastases or oligo-progression (\\\u003C 5 metastases in less than 3 sites)\n  * Second non-metastatic cancer\n  * Isolated local recurrence\n* Life expectancy \\> 6 months\n* Dated and signed informed consent\n* Affiliation to a social security scheme or equivalent\n\nExclusion Criteria:\n\n* Indication of intracranial, prostate, rectum or esophagus re-irradiation\n* Diagnosis of multi-metastatic cancer\n* PS ECOG ≥ 2\n* Impossibility to interrupt current treatment with a tyrosine kinase inhibitor or other systemic treatment (excluding hormonal therapy) which may potentiate the rays effects (duration of wash-out according to treatment instructions)\n* Pregnant or breastfeeding women\n* Tutorship or curatorship or deprivation of liberty",{"count":52,"type":20},100,"INTERVENTIONAL",[55],"NA","We propose to evaluate the contribution of a standardized process combining,\n\n* a validation of re-irradiation indications by a group of multi-professional experts (radiotherapists and physicists) and,\n* a collective validation of the accumulation of doses on all the organs of the anatomical region concerned obtained using deformable fusion software (MiM) allowing the accumulation of doses in terms of Equivalent Dose 2 Grays (EQD2).\n\nThe primary objective of this study is to determine the rate of patients for whom this process has changed the treatment plan.",[26,58],"Radiotherapy",[26,58,60,61,62],"Equivalent dose 2 grays","Feasibility","Cumulative doses","NOT_YET_RECRUITING","2024-10-30",{"date":66,"type":34},"2024-10-31",{"date":68,"type":20},"2024-11-01",{"date":70,"type":20},"2029-02-01",{"name":72,"class":41},"Centre Leon Berard",10]