Recurrent Gynecologic CancerRegynera-RTNCT07667192
Reirradiation and Total Ablative Strategies for Recurrent Gynecologic Cancer
An observational study of Recurrent Gynecologic Cancer and Recurrent Uterine Cancer, run by Affidea Nu-med Center of Oncological DIagnostics and Therapy at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent Gynecologic Cancer, Recurrent Uterine Cancer, Recurrent Cervical Cancer
- What is being tested?
- Reirradiation and Total Ablative Strategy
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 sitePoland
- Study dates
- 11 Jun 2026to Dec 2036
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- - 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Affidea NU-MED Center of Oncological Diagnostics and Therapy
Zamość, Lublin Voivodeship, 22-400
Mateusz Bilski, MD, PhD, 84 535 99 10 ext. 048, mateusz.bilski@affidea.com
Paulina Kleban, MGR, 84 535 99 10 ext. 048, paulina.kleban@affidea.com
About this study
Official title: REGYNERA(Dia)TION: An Ambispective International Multicenter Patient Registry of Reirradiation and Total Ablative Strategies for Recurrent Gynecologic Malignancies
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.
Read the 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.
- Conditions
- Recurrent Gynecologic Cancer, Recurrent Uterine Cancer, Recurrent Cervical Cancer, Recurrent Vaginal Cancer, Recurrent Vulvar Cancer, Recurrent Ovarian Cancer
- Being tested
- Reirradiation, Total Ablative Strategy
- 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
- Medical subject headings
- Uterine Neoplasms, Uterine Cervical Neoplasms, Vaginal Neoplasms, Vulvar Neoplasms, Ovarian Neoplasms, Fallopian Tube Neoplasms, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReirradiationRadiation
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.
Total Ablative StrategyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Reirradiation; Other: Total Ablative Strategy | |
| 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 Receives: Radiation: Reirradiation; Other: Total Ablative Strategy | |
| 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. Receives: Radiation: Reirradiation; Other: Total Ablative Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From treatment start to progression or death, up to 5 years
Secondary outcomes (10)
Severe Treatment-Related Adverse Events
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.
Measured: From treatment start through 24 months and longer follow-up, up to 5 years
Overall Survival
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.
Measured: From treatment start to death or last follow-up, up to 5 years
Fistula Events
Incidence of new or worsening fistula events, including anatomical type, timing, suspected relationship to treatment, management, surgical intervention, and resolution or persistence.
Measured: From treatment start through 24 months and long-term follow-up, up to 5 years
Complete Response
Proportion of participants with disappearance of all treated measurable active disease sites and no new disease, assessed by routine imaging and/or clinical assessment.
Measured: 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
Time from completion of reirradiation and/or total ablative strategy to local recurrence or progression in the treated region, or death.
Measured: From treatment completion to local progression or death, up to 5 years
From treatment completion to local progression or death, up to 5 years
Time from treatment completion to regional nodal recurrence or progression, or death.
Measured: From treatment completion to regional progression or death, up to 5 years
Distant Metastasis-Free Survival
Time from completion of reirradiation and/or total ablative strategy to distant metastatic progression or death from any cause.
Measured: From treatment completion to event or last follow-up, up to 5 years
Freedom From Oligometastatic Reccurence/Progression
Time to new oligometastatic recurrence or oligometastatic progression after reirradiation and/or total ablative strategy, assessed according to investigator review and local imaging practice.
Measured: From treatment completion to event or last follow-up, up to 5 years
Freedom From Polymetastatic Recurrence/Progression
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.
Measured: From treatment completion to polymetastatic progression, up to 5 years
Pattern of First Failure
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.
Measured: From treatment completion to first progression, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start11 Jun 2026
- Primary completionDec 2031 (estimated)
- Study completionDec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Recurrent Gynecologic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Affidea Nu-med Center of Oncological DIagnostics and Therapy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07667192
- Sponsor's protocol ID
- REGYNE(RA)DIATION
- Acronym
- Regynera-RT
- Status last verified
- Oct 2026
- First submitted
- 11 Jun 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 35537576Ling 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.
PubMed 31150869Ling 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.
PubMed 30600093Lee 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.
PubMed 35078717Bockel 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.
PubMed 33799617Critelli 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.
PubMed 37913639Andratschke 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.
PubMed 36174633
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REGYNERA(Dia)TION: An Ambispective International Multicenter Patient Registry of Reirradiation and Total Ablative Strategies for Recurrent Gynecologic Malignancies
- ClinicalTrials.gov ID
- NCT07667192
- Acronym / sponsor ID
- Regynera-RT / REGYNE(RA)DIATION
- Conditions
- Recurrent Gynecologic Cancer, Recurrent Uterine Cancer, Recurrent Cervical Cancer, Recurrent Vaginal Cancer, Recurrent Vulvar Cancer, Recurrent Ovarian Cancer
- Keywords
- Reirradiation, Radiotherapy, Brachytherapy, External Beam Radiotherapy, Stereotactic Body Radiotherapy, Proton Therapy, Intraoperative Radiotherapy, Total Ablative Strategy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Affidea Nu-med Center of Oncological DIagnostics and TherapyUniversity, hospital or other
- Study start
- 11 Jun 2026 (actual)
- Primary completion
- Dec 2031 (estimated)
- Study completion
- Dec 2036 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Historical Retrospective Cohort | – | Radiation: Reirradiation, Other: Total Ablative StrategyPatients 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 | – | Radiation: Reirradiation, Other: Total Ablative StrategyPatients 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 | – | Radiation: Reirradiation, Other: Total Ablative StrategyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- - 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReirradiationObserved 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. | Radiation | Ambispective Follow-Up Cohort, Historical Retrospective Cohort, Prospective Registry Cohort |
| Total Ablative StrategyObserved 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. | Other | Ambispective Follow-Up Cohort, Historical Retrospective Cohort, Prospective Registry Cohort |
Primary outcome
Radiographic Progression-Free Survival
Time frame: 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.
10 secondary outcomes
Severe Treatment-Related Adverse Events
Time frame: From treatment start through 24 months and longer follow-up, up to 5 years
Overall Survival
Time frame: From treatment start to death or last follow-up, up to 5 years
Fistula Events
Time frame: From treatment start through 24 months and long-term follow-up, up to 5 years
Complete Response
Time frame: 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
Time frame: From treatment completion to local progression or death, up to 5 years
From treatment completion to local progression or death, up to 5 years
Time frame: From treatment completion to regional progression or death, up to 5 years
Distant Metastasis-Free Survival
Time frame: From treatment completion to event or last follow-up, up to 5 years
Freedom From Oligometastatic Reccurence/Progression
Time frame: From treatment completion to event or last follow-up, up to 5 years
Freedom From Polymetastatic Recurrence/Progression
Time frame: From treatment completion to polymetastatic progression, up to 5 years
Pattern of First Failure
Time frame: From treatment completion to first progression, up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Background: PubMed 35537576Mulani 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.
- Background: PubMed 31150869Ling 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.
- Background: PubMed 30600093Ling 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.
- Background: PubMed 35078717Lee 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.
- Background: PubMed 33799617Bockel 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.
- Background: PubMed 37913639Critelli 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.
- Background: PubMed 36174633Andratschke 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.
- Individual participant dataSharing planned: No. 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.
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Gynecological Malignancies
Active, not recruitingPhase 2
A Study of Avutometinib (VS-6766) and Defactinib in People With Mesonephric Gynecologic Cancer
Mesonephric Gynecologic Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Gynecologic Cancer and Recurrent Uterine Cancer, run by Affidea Nu-med Center of Oncological DIagnostics and Therapy at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mateusz Bilski, Md, PhD (84 535 99 10 ext. 048, mateusz.bilski@affidea.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic Progression-Free Survival (time frame: From treatment start to progression or death, up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07667192, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.