Reirradiation and Total Ablative Strategies for Recurrent Gynecologic Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorAffidea Nu-med Center of Oncological DIagnostics and Therapy

About this trial

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.

Eligibility criteria

Qualifiers

- 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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Reirradiation
  • Total Ablative Strategy

Treatment groups

500 Participants
are divided into 3 treatment groups