Reirradiation and Total Ablative Strategies for Recurrent Gynecologic Cancer
Regynera-RT
REGYNERA(Dia)TION: An Ambispective International Multicenter Patient Registry of Reirradiation and Total Ablative Strategies for Recurrent Gynecologic Malignancies
1 other identifier
observational
500
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2026
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2026
CompletedStudy Start
First participant enrolled
June 11, 2026
CompletedFirst Posted
Study publicly available on registry
June 24, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2036
June 24, 2026
June 1, 2026
5.5 years
June 11, 2026
June 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
From treatment start to progression or death, up to 5 years
Secondary Outcomes (10)
Severe Treatment-Related Adverse Events
From treatment start through 24 months and longer follow-up, up to 5 years
Overall Survival
From treatment start to death or last follow-up, up to 5 years
Fistula Events
From treatment start through 24 months and long-term follow-up, up to 5 years
Complete Response
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
From treatment completion to local progression or death, up to 5 years
- +5 more secondary outcomes
Other Outcomes (2)
Pelvic Exenteration-Free Survival
From treatment completion to pelvic exenteration or death, up to 5 years.
Systemic Therapy-Free Survival
From treatment completion to initiation or escalation of systemic therapy, up to 5 years.
Study Arms (3)
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.
Interventions
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.
Eligibility Criteria
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.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Affidea NU-MED Center of Oncological Diagnostics and Therapy
Zamość, Lublin Voivodeship, 22-400, Poland
Related Publications (7)
Mulani J, Jain J, Gupta A, Swamidas J, Paul S, Mittal P, Gurram L, Chopra S. Dose Accumulation for Multicourse Gynecological Reirradiation: A Methodological Narrative and Clinical Examples. Int J Radiat Oncol Biol Phys. 2022 Aug 1;113(5):1085-1090. doi: 10.1016/j.ijrobp.2022.04.046. Epub 2022 May 7.
PMID: 35537576BACKGROUNDLing DC, Vargo JA, Burton SA, Heron DE, Beriwal S. Salvage Curative-Intent Reirradiation Stereotactic Body Radiation Therapy for Isolated Pelvic and/or Paraortic Recurrences of Gynecologic Malignancies. Pract Radiat Oncol. 2019 Nov;9(6):418-425. doi: 10.1016/j.prro.2019.05.012. Epub 2019 May 28.
PMID: 31150869BACKGROUNDLing DC, Vargo JA, Glaser SM, Kim H, Beriwal S. Outcomes after definitive re-irradiation with 3D brachytherapy with or without external beam radiation therapy for vaginal recurrence of endometrial cancer. Gynecol Oncol. 2019 Mar;152(3):581-586. doi: 10.1016/j.ygyno.2018.12.022. Epub 2018 Dec 29.
PMID: 30600093BACKGROUNDLee LJ, Alban GM, Cheng T, Buzurovic I, Pretz J, Singer L, King MT. Clinical outcomes and dosimetric predictors of toxicity for re-irradiation of vaginal recurrence of endometrial cancer. Brachytherapy. 2022 May-Jun;21(3):263-272. doi: 10.1016/j.brachy.2021.12.010. Epub 2022 Jan 22.
PMID: 35078717BACKGROUNDBockel S, Espenel S, Sun R, Dumas I, Gouy S, Morice P, Chargari C. Image-Guided Brachytherapy for Salvage Reirradiation: A Systematic Review. Cancers (Basel). 2021 Mar 11;13(6):1226. doi: 10.3390/cancers13061226.
PMID: 33799617BACKGROUNDCritelli P, Pezzulla D, Lillo S, Arpa D, Scricciolo M, Di Carlo C, Argenone A, Borzillo V, Marsella AR, Tamburo M, Di Franco R, Di Marzo A, Settineri N, Mondello S, Macchia G, Belgioia L, Cerrotta A, Pontoriero A. Outcomes and toxicity in re-irradiation of gynecologic cancer: Systematic review of the Italian association of radiation and clinical oncology (AIRO). Gynecol Oncol. 2023 Dec;179:33-41. doi: 10.1016/j.ygyno.2023.10.016. Epub 2023 Oct 30.
PMID: 37913639BACKGROUNDAndratschke N, Willmann J, Appelt AL, Alyamani N, Balermpas P, Baumert BG, Hurkmans C, Hoyer M, Langendijk JA, Kaidar-Person O, van der Linden Y, Meattini I, Niyazi M, Reynaert N, De Ruysscher D, Tanadini-Lang S, Hoskin P, Poortmans P, Nieder C. European Society for Radiotherapy and Oncology and European Organisation for Research and Treatment of Cancer consensus on re-irradiation: definition, reporting, and clinical decision making. Lancet Oncol. 2022 Oct;23(10):e469-e478. doi: 10.1016/S1470-2045(22)00447-8.
PMID: 36174633BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2026
First Posted
June 24, 2026
Study Start
June 11, 2026
Primary Completion (Estimated)
December 1, 2031
Study Completion (Estimated)
December 1, 2036
Last Updated
June 24, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share
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.