Reirradiation and Total Ablative Strategies for Recurrent Gynecologic Cancer

Recruiting now

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT07667192

Run by

Affidea Nu-med Center of Oncological DIagnostics and Therapy

People needed

500

Starts

2026-06-11

Expected to finish

2036-12-01

Last updated by the study team

2026-06-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• - 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.

You may not qualify if…

• 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 is running

• Affidea NU-MED Center of Oncological Diagnostics and Therapy — Zamość, Lublin Voivodeship, Poland (enrolling)

Full record on ClinicalTrials.gov

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