[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644252":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":10,"centralContacts":33,"locations":43,"responsibleParty":62,"collaborators":10,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":10,"enrollmentInfo":74,"targetDuration":77,"studyType":78,"phases":10,"briefSummary":79,"conditions":80,"keywords":89,"overallStatus":46,"whyStopped":10,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Affidea Nu-med Center of Oncological DIagnostics and Therapy","OTHER",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Historical Retrospective Cohort",null,"Patients treated with reirradiation and\u002For total ablative strategies before registry activation at a participating site. Baseline, prior radiotherapy, recurrence, treatment exposure, response, toxicity, progression, and survival data are abstracted retrospectively from medical records and treatment-planning systems according to local approval.",[13,14],"Radiation: Reirradiation","Other: Total Ablative Strategy",{"label":16,"type":10,"description":17,"interventionNames":18},"Ambispective Follow-Up Cohort","Patients treated before registry activation who remain under follow-up. Baseline, prior treatment, recurrence, and reirradiation data may be collected retrospectively, while subsequent imaging, response, adverse events, fistula events, progression, survival, and patient-reported outcomes may be collected prospectively where permitted",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Prospective Registry Cohort","Patients enrolled before or at the time of the reirradiation or total ablative strategy decision. Treatment is not assigned by the registry and is selected by the treating multidisciplinary team according to routine clinical practice. Registry data are collected prospectively according to the protocol follow-up schedule.",[13,14],[24,29],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"RADIATION","Reirradiation","Observed standard-of-care radiotherapy delivered in a previously irradiated patient or to a target region overlapping with or clinically affected by prior radiotherapy. Modalities may include brachytherapy, external-beam radiotherapy, stereotactic body radiotherapy, proton therapy, intraoperative radiotherapy, or combinations. Dose and fractionation are selected by the treating team.",[16,9,20],{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":10},"Total Ablative Strategy","Observed standard-of-care curative-intent or ablative-intent treatment strategy directed at all visible active disease sites when technically feasible and clinically appropriate. This may include radiotherapy, surgery, ablation, metastasis-directed therapy, systemic therapy, or combinations, as selected by the treating multidisciplinary team.",[16,9,20],[34,40],{"name":35,"role":36,"phone":37,"phoneExt":38,"email":39},"Mateusz Bilski, Md, PhD","CONTACT","84 535 99 10","048","mateusz.bilski@affidea.com",{"name":41,"role":36,"phone":37,"phoneExt":38,"email":42},"Paulina Kleban, MGR","paulina.kleban@affidea.com",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Affidea NU-MED Center of Oncological Diagnostics and Therapy","RECRUITING","Zamość","Lublin Voivodeship","22-400","Poland","PL",{"type":53,"coordinates":54},"Point",[55,56],23.25196,50.72314,{"lat":56,"lon":55},[59,61],{"name":60,"role":36,"phone":37,"phoneExt":38,"email":39},"Mateusz Bilski, MD, PhD",{"name":41,"role":36,"phone":37,"phoneExt":38,"email":42},{"type":63,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100644252","reirradiation-and-total-ablative-strategies-for-recurrent-gynecologic-cancer-100644252",false,"NCT07667192","Reirradiation and Total Ablative Strategies for Recurrent Gynecologic Cancer","REGYNERA(Dia)TION: An Ambispective International Multicenter Patient Registry of Reirradiation and Total Ablative Strategies for Recurrent Gynecologic Malignancies","Regynera-RT","Inclusion Criteria:\n\n* \\- Age 18 years or older at the time of reirradiation or prospective enrollment.\n* Histologically confirmed gynecologic malignancy, including uterine, cervical, vaginal, vulvar, ovarian, fallopian tube, primary peritoneal, or rare gynecologic primary.\n* Documented prior radiotherapy delivered as part of previous treatment.\n* Recurrent or progressive disease for which reirradiation and\u002For total ablative strategy has been delivered, is ongoing, or is planned according to local multidisciplinary decision-making.\n* Recurrence or progression documented by imaging, clinical examination, pathology, and\u002For multidisciplinary tumor board assessment according to institutional practice.\n* Availability of minimum essential data, including prior radiotherapy information, date of reirradiation or planned reirradiation, disease extent at reirradiation, and at least one follow-up, outcome, or survival-status record for retrospective patients.\n* For prospective patients, written informed consent where required by local regulations and ethics approval.\n\nExclusion Criteria:\n\n* No evidence of prior radiotherapy.\n* No reirradiation or clinically meaningful local ablative radiotherapy component delivered or planned.\n* Insufficient minimum data preventing assignment of reirradiation date, disease extent, or survival\u002Ffollow-up status.\n* Exclusively polymetastatic disease with more than 5 active non-regional lesions treated without a meaningful local reirradiation or total ablative component, unless included in an exploratory non-core substudy approved by the steering committee.\n* Prospective refusal of consent when consent is required by local law or ethics approval.","FEMALE","18 Years",{"count":75,"type":76},500,"ESTIMATED","5 Years","OBSERVATIONAL","REGYNERA(dia)TION is an international, multicenter, ambispective observational patient registry of adults with recurrent gynecologic malignancies after prior radiotherapy who are treated or planned for reirradiation and\u002For total ablative strategies as part of routine clinical care. The registry does not assign treatment. Radiotherapy technique, dose, systemic therapy, surgery, metastasis-directed therapy, imaging, and follow-up are selected by the treating multidisciplinary team according to local standards and patient-specific factors. The registry will collect harmonized retrospective and prospective data on disease characteristics, prior radiotherapy, recurrence pattern, reirradiation or ablative treatment exposure, response, progression, survival, severe treatment-related morbidity, fistula events, and patient-reported outcomes where available.",[81,82,83,84,85,86,87,88],"Recurrent Gynecologic Cancer","Recurrent Uterine Cancer","Recurrent Cervical Cancer","Recurrent Vaginal Cancer","Recurrent Vulvar Cancer","Recurrent Ovarian Cancer","Recurrent Fallopian Tube Cancer","Primary Peritoneal Cancer",[26,90,91,92,93,94,95,30,96,97,98,99,100,101,102],"Radiotherapy","Brachytherapy","External Beam Radiotherapy","Stereotactic Body Radiotherapy","Proton Therapy","Intraoperative Radiotherapy","Oligometastatic Recurrence","Metastasis-Directed Therapy","Patient Registry","Radiographic Progression-Free Survival","Treatment-Related Adverse Events","Fistula","Overall survival","2026-06-20",{"date":105,"type":106},"2026-06-24","ACTUAL",{"date":108,"type":106},"2026-06-11",{"date":110,"type":76},"2036-12",{"name":5,"class":6},1]