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/or 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.
- Age 18 years or older at the time of reirradiation or prospective enrollment.
Histologically confirmed gynecologic malignancy, including uterine, cervical, vaginal, vulvar, ovarian, fallopian tube, primary peritoneal, or rare gynecologic primary.
Documented prior radiotherapy delivered as part of previous treatment.
Recurrent or progressive disease for which reirradiation and/or total ablative strategy has been delivered, is ongoing, or is planned according to local multidisciplinary decision-making.
No evidence of prior radiotherapy.
No reirradiation or clinically meaningful local ablative radiotherapy component delivered or planned.
Insufficient minimum data preventing assignment of reirradiation date, disease extent, or survival/follow-up status.
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.
Adult patients with histologically confirmed recurrent gynecologic malignancy after prior radiotherapy, treated with, planned for, or undergoing reirradiation and/or total ablative strategy according to local multidisciplinary decision-making.
Cohort
Other
Reirradiation
RadiationObserved 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.
Total Ablative Strategy
Other interventionObserved 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.
Radiographic Progression-Free Survival
Time from the start of reirradiation and/or total ablative strategy to first radiographic disease progression at any site or death from any cause, whichever occurs first. Progression will be assessed using routine clinical imaging and investigator assessment according to local practice.
Severe Treatment-Related Adverse Events
Incidence of grade 3 or higher treatment-related genitourinary, gastrointestinal, vaginal, soft-tissue, neurologic, vascular, bone, or other clinically relevant adverse events after reirradiation and/or total ablative strategy, graded according to the version of CTCAE used at the participating site.
Overall Survival
Time from the start of reirradiation and/or total ablative strategy to death from any cause. Participants alive at last follow-up will be censored at the last known alive date.
Fistula Events
Incidence of new or worsening fistula events, including anatomical type, timing, suspected relationship to treatment, management, surgical intervention, and resolution or persistence.
Complete Response
Proportion of participants with disappearance of all treated measurable active disease sites and no new disease, assessed by routine imaging and/or clinical assessment.
Pelvic Exenteration-Free Survival
Time from completion of reirradiation and/or total ablative strategy to pelvic exenteration or death, assessed in selected pelvic recurrence cohorts where applicable.
Systemic Therapy-Free Survival
Time from completion of reirradiation and/or total ablative strategy to initiation or escalation of systemic anticancer therapy, assessed as an exploratory endpoint where clinically applicable.
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