Primary Peritoneal Cancer, Recurrent Cervical Cancer, Recurrent Fallopian Tube Cancer, Recurrent Gynecologic Cancer, Recurrent Ovarian Cancer, Recurrent Uterine Cancer, Recurrent Vaginal Cancer, Recurrent Vulvar Cancer
Conditions
Keywords
Reirradiation, Radiotherapy, Brachytherapy, External Beam Radiotherapy, Stereotactic Body Radiotherapy, Proton Therapy, Intraoperative Radiotherapy, Total Ablative Strategy, Oligometastatic Recurrence, Metastasis-Directed Therapy, Patient Registry, Radiographic Progression-Free Survival, Treatment-Related Adverse Events, Fistula, Overall survival
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.
Detailed description
This study is a non-interventional patient registry designed to describe real-world outcomes after reirradiation and total ablative strategies in recurrent gynecologic malignancies. Eligible participants are adults with histologically confirmed uterine, cervical, vaginal, vulvar, ovarian, fallopian tube, primary peritoneal, or other rare gynecologic malignancy; documented prior radiotherapy; and recurrent or progressive disease for which reirradiation and/or a local ablative treatment strategy has been delivered, is ongoing, or is planned according to local multidisciplinary decision-making. The registry has an ambispective cohort structure. Historical retrospective participants are entered from medical records and treatment-planning data after local approval. Ambispective follow-up participants were treated before registry activation but remain under follow-up, allowing subsequent outcomes and adverse events to be captured prospectively where permitted. Prospective registry participants are enrolled before or at the time of reirradiation or total ablative strategy decision-making. Participation does not mandate, delay, prohibit, or modify any clinically indicated treatment, imaging, or follow-up. The registry will capture a common core dataset across participating centers, including demographics, performance status, primary tumor site and histology, primary treatment, prior radiotherapy details, recurrence anatomy, disease extent, number and site of active foci, treatment modality, dose and fractionation, equivalent dose metrics, systemic therapy timing, surgery or other metastasis-directed therapy, response at approximately 3 and 6 months, progression pattern, survival status, acute and late adverse events, severe morbidity, fistula events, and patient-reported outcomes where implemented. Recommended extended data domains include cumulative dose assessment, organ-at-risk metrics, imaging response method, molecular markers, systemic therapy sequencing, dosimetric data, and quality-of-life or symptom questionnaires. The primary registry endpoint is radiographic progression-free survival after reirradiation/total ablative strategy. Key safety analyses will describe grade 3 or higher treatment-related genitourinary, gastrointestinal, vaginal, soft-tissue, neurologic, vascular, or bone adverse events and fistula events within 24 months and during longer follow-up. Secondary analyses will describe complete response, overall survival, local, regional, and distant progression, freedom from oligometastatic or polymetastatic progression, and disease-site-specific outcomes when adequate sample size and event numbers are reached.
Interventions
RADIATIONReirradiation
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.
OTHERTotal Ablative Strategy
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.
Sponsors
Affidea Nu-med Center of Oncological DIagnostics and Therapy
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Progression-Free Survival | From treatment start to progression or death, up to 5 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severe Treatment-Related Adverse Events | From treatment start through 24 months and longer follow-up, up to 5 years | Incidence of grade 3 or higher treatment-related genitourinary, gastrointestinal, vaginal, soft-tissue, neurologic, vascular, bone, or other clinically relevant adverse events after reirradiation and/or total ablative strategy, graded according to the version of CTCAE used at the participating site. |
| Overall Survival | From treatment start to death or last follow-up, up to 5 years | Time from the start of reirradiation and/or total ablative strategy to death from any cause. Participants alive at last follow-up will be censored at the last known alive date. |
| Fistula Events | From treatment start through 24 months and long-term follow-up, up to 5 years | Incidence of new or worsening fistula events, including anatomical type, timing, suspected relationship to treatment, management, surgical intervention, and resolution or persistence. |
| 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. | Proportion of participants with disappearance of all treated measurable active disease sites and no new disease, assessed by routine imaging and/or clinical assessment. |
| Local Recurrence-Free Survival | From treatment completion to local progression or death, up to 5 years | Time from completion of reirradiation and/or total ablative strategy to local recurrence or progression in the treated region, or death. |
| From treatment completion to local progression or death, up to 5 years | From treatment completion to regional progression or death, up to 5 years | Time from treatment completion to regional nodal recurrence or progression, or death. |
| Distant Metastasis-Free Survival | From treatment completion to event or last follow-up, up to 5 years | Time from completion of reirradiation and/or total ablative strategy to distant metastatic progression or death from any cause. |
| Freedom From Oligometastatic Reccurence/Progression | From treatment completion to event or last follow-up, up to 5 years | Time to new oligometastatic recurrence or oligometastatic progression after reirradiation and/or total ablative strategy, assessed according to investigator review and local imaging practice. |
| Freedom From Polymetastatic Recurrence/Progression | From treatment completion to polymetastatic progression, up to 5 years | Time from completion of reirradiation and/or total ablative strategy to development of polymetastatic progression, typically defined as more than 5 new and/or regrowing non-regional lesions. |
| Pattern of First Failure | From treatment completion to first progression, up to 5 years | Distribution of first progression pattern after reirradiation and/or total ablative strategy, classified as local, regional, distant, oligometastatic, polymetastatic, or mixed progression according to investigator assessment. |
Countries
Poland
Contacts
CONTACTMateusz Bilski, Md, PhD
CONTACTPaulina Kleban, MGR
Outcome results
None listed