Reirradiation and Total Ablative Strategies for Recurrent Gynecologic Cancer (REGYNERA-tion) Registry

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

REGYNERATION is an international, multicenter, ambispective observational registry of adults with recurrent gynecologic cancers who have had prior radiotherapy and are treated or planned for reirradiation or total ablative strategies as part of routine care. The study does not assign treatments; data are collected from medical records and clinical decision-making, including radiotherapy details, systemic therapy, surgery, imaging, and follow-up. Researchers will describe patterns of care, responses, progression, survival, treatment-related morbidity, fistula events, and patient-reported outcomes when available. The registry uses historical retrospective data and prospective follow-up to capture real-world experiences across participating centers. Participation does not alter standard clinical management.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* \- 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.
* Recurrence or progression documented by imaging, clinical examination, pathology, and/or multidisciplinary tumor board assessment according to institutional practice.
* 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.
* For prospective patients, written informed consent where required by local regulations and ethics approval.

Exclusion Criteria:

* 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.
* Prospective refusal of consent when consent is required by local law or ethics approval.

Where it's running

• Affidea NU-MED Center of Oncological Diagnostics and Therapy
  Zamość, Lublin Voivodeship, Poland Recruiting

Study contacts

• Study coordinator: Mateusz Bilski, Md, PhD
• Email: mateusz.bilski@affidea.com
• Phone: 84 535 99 10

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.