[{"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,[8,41],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"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":19,"type":20},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.",[24,25,26,27],"Locoregional Recurrence","Breast Cancer","Re-irradiation","Hyperthermia","RECRUITING","2025-09-30",{"date":31,"type":32},"2025-10-06","ACTUAL",{"date":34,"type":32},"2024-01-01",{"date":36,"type":20},"2027-05",{"name":38,"class":39},"Amsterdam UMC, location VUmc","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"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":50,"type":20},100,"INTERVENTIONAL",[53],"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.",[26,56],"Radiotherapy",[26,56,58,59,60],"Equivalent dose 2 grays","Feasibility","Cumulative doses","NOT_YET_RECRUITING","2024-10-30",{"date":64,"type":32},"2024-10-31",{"date":66,"type":20},"2024-11-01",{"date":68,"type":20},"2029-02-01",{"name":70,"class":39},"Centre Leon Berard",10]