An observational study in Recurrent Gynecologic Cancer, Recurrent Uterine Cancer and Recurrent Cervical Cancer, sponsored by Affidea Nu-med Center of Oncological DIagnostics and Therapy. Recruiting at 1 site in Poland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by Affidea Nu-med Center of Oncological DIagnostics and Therapy · 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/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.
This study is a non-interventional patient registry designed to describe real-world outcomes after reirradiation and total ablative strategies in recurrent gynecologic malignancies. Eligible participants are adults with histologically confirmed uterine, cervical, vaginal, vulvar, ovarian, fallopian tube, primary peritoneal, or other rare gynecologic malignancy; documented prior radiotherapy; and recurrent or progressive disease for which reirradiation and/or a local ablative treatment strategy has been delivered, is ongoing, or is planned according to local multidisciplinary decision-making.
The registry has an ambispective cohort structure. Historical retrospective participants are entered from medical records and treatment-planning data after local approval. Ambispective follow-up participants were treated before registry activation but remain under follow-up, allowing subsequent outcomes and adverse events to be captured prospectively where permitted. Prospective registry participants are enrolled before or at the time of reirradiation or total ablative strategy decision-making. Participation does not mandate, delay, prohibit, or modify any clinically indicated treatment, imaging, or follow-up.
The registry will capture a common core dataset across participating centers, including demographics, performance status, primary tumor site and histology, primary treatment, prior radiotherapy details, recurrence anatomy, disease extent, number and site of active foci, treatment modality, dose and fractionation, equivalent dose metrics, systemic therapy timing, surgery or other metastasis-directed therapy, response at approximately 3 and 6 months, progression pattern, survival status, acute and late adverse events, severe morbidity, fistula events, and patient-reported outcomes where implemented. Recommended extended data domains include cumulative dose assessment, organ-at-risk metrics, imaging response method, molecular markers, systemic therapy sequencing, dosimetric data, and quality-of-life or symptom questionnaires.
The primary registry endpoint is radiographic progression-free survival after reirradiation/total ablative strategy. Key safety analyses will describe grade 3 or higher treatment-related genitourinary, gastrointestinal, vaginal, soft-tissue, neurologic, vascular, or bone adverse events and fistula events within 24 months and during longer follow-up. Secondary analyses will describe complete response, overall survival, local, regional, and distant progression, freedom from oligometastatic or polymetastatic progression, and disease-site-specific outcomes when adequate sample size and event numbers are reached.
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.
Exclusion Criteria:
Patients treated with reirradiation and/or 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.
Radiation: Reirradiation · Other: Total Ablative Strategy
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
Radiation: Reirradiation · Other: Total Ablative Strategy
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.
Radiation: Reirradiation · Other: Total Ablative Strategy
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.
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.
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.
Time frame: From treatment start to progression or death, up to 5 years
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.
Time frame: From treatment start through 24 months and longer follow-up, up to 5 years
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.
Time frame: From treatment start to death or last follow-up, up to 5 years
Fistula Events
Incidence of new or worsening fistula events, including anatomical type, timing, suspected relationship to treatment, management, surgical intervention, and resolution or persistence.
Time frame: From treatment start through 24 months and long-term follow-up, up to 5 years
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.
Time frame: From treatment completion through 5 years, with response assessed at approximately 3 and 6 months after treatment completion and during scheduled follow-up.
Local Recurrence-Free Survival
Time from completion of reirradiation and/or total ablative strategy to local recurrence or progression in the treated region, or death.
Time frame: From treatment completion to local progression or death, up to 5 years
From treatment completion to local progression or death, up to 5 years
Time from treatment completion to regional nodal recurrence or progression, or death.
Time frame: From treatment completion to regional progression or death, up to 5 years
Distant Metastasis-Free Survival
Time from completion of reirradiation and/or total ablative strategy to distant metastatic progression or death from any cause.
Time frame: From treatment completion to event or last follow-up, up to 5 years
Freedom From Oligometastatic Reccurence/Progression
Time to new oligometastatic recurrence or oligometastatic progression after reirradiation and/or total ablative strategy, assessed according to investigator review and local imaging practice.
Time frame: From treatment completion to event or last follow-up, up to 5 years
Freedom From Polymetastatic Recurrence/Progression
Time from completion of reirradiation and/or total ablative strategy to development of polymetastatic progression, typically defined as more than 5 new and/or regrowing non-regional lesions.
Time frame: From treatment completion to polymetastatic progression, up to 5 years
Pattern of First Failure
Distribution of first progression pattern after reirradiation and/or total ablative strategy, classified as local, regional, distant, oligometastatic, polymetastatic, or mixed progression according to investigator assessment.
Time frame: From treatment completion to first progression, up to 5 years
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.
Time frame: From treatment completion to pelvic exenteration or death, up to 5 years.
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.
Time frame: From treatment completion to initiation or escalation of systemic therapy, up to 5 years.
Plan to share: No — Individual participant-level data will not be made publicly available because the registry includes rare gynecologic malignancy cohorts, retrospective and prospective international data, treatment-planning and imaging-derived variables, and potentially re-identifiable clinical details. Data will be pseudonymized or deidentified before central transfer and handled according to local ethics approvals, data-use agreements, GDPR, and applicable institutional data-protection requirements. Aggregate results and summary analyses are planned for dissemination through scientific publications and conference presentations.
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Affidea Nu-med Center of Oncological DIagnostics and Therapy