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REGYNERA(Dia)TION: An Ambispective International Multicenter Patient Registry of Reirradiation and Total Ablative Strategies for Recurrent Gynecologic Malignancies

Status: Recruiting
Location: See location...
Intervention Type: Radiation, Other
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• \- 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.

Locations
Other Locations
Poland
Affidea NU-MED Center of Oncological Diagnostics and Therapy
RECRUITING
Zamość
Contact Information
Primary
Mateusz Bilski, Md, PhD
mateusz.bilski@affidea.com
84 535 99 10
Backup
Paulina Kleban, MGR
paulina.kleban@affidea.com
84 535 99 10
Time Frame
Start Date: 2026-06-11
Estimated Completion Date: 2036-12
Participants
Target number of participants: 500
Treatments
Historical Retrospective Cohort
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.
Ambispective Follow-Up Cohort
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
Prospective Registry Cohort
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.
Sponsors
Leads: Affidea Nu-med Center of Oncological DIagnostics and Therapy

This content was sourced from clinicaltrials.gov