Clinical trial · Observational
Reirradiation and Total Ablative Strategies for Recurrent Gynecologic Cancer
REGYNERA(Dia)TION: An Ambispective International Multicenter Patient Registry of Reirradiation and Total Ablative Strategies for Recurrent Gynecologic Malignancies
NCT07667192CI-TRIAL-00115741Regynera-RTrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Peritoneal Cancer | — | UNRESOLVED | — |
| Recurrent Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Recurrent Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | CURATED_BROADER | 0.78 |
| Recurrent Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | CURATED_BROADER | 0.78 |
| Recurrent Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
| Recurrent Uterine Cancer | Malignant Uterine Neoplasm | CURATED_BROADER | 0.78 |
| Recurrent Vaginal Cancer | Malignant Vaginal Neoplasm | CURATED_BROADER |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Reirradiation | Radiation | — | UNRESOLVED |
| Total Ablative Strategy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Historical Retrospective Cohort
- description
- 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.
- interventionNames
- Radiation: Reirradiation
- Other: Total Ablative Strategy
- label
- Ambispective Follow-Up Cohort
- description
- 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
- interventionNames
- Radiation: Reirradiation
- Other: Total Ablative Strategy
- label
- Prospective Registry Cohort
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (7)
- BACKGROUNDMulani 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 35537576
- BACKGROUNDLing 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 31150869
- BACKGROUNDLing 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 30600093
- BACKGROUNDLee 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 35078717
- BACKGROUNDBockel 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 33799617
- BACKGROUNDCritelli 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.