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Reirradiation and Total Ablative Strategies for Recurrent Gynecologic Cancer (Regynera-RT)

20 giugno 2026 aggiornato da: Affidea Nu-med Center of Oncological DIagnostics and Therapy

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

500

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Polonia
    • Lublin Voivodeship
      • Zamość, Lublin Voivodeship, Polonia, 22-400
        • Reclutamento
        • Affidea Nu-med Center of Oncological Diagnostics and Therapy
        • Contatto:
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
Radiazione: Reirradiation
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.
Altro: Total 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.
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
Radiazione: Reirradiation
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.
Altro: Total 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.
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.
Radiazione: Reirradiation
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.
Altro: Total 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Radiographic Progression-Free Survival
Lasso di tempo: 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.
From treatment start to progression or death, up to 5 years

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Severe Treatment-Related Adverse Events
Lasso di tempo: 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.
From treatment start through 24 months and longer follow-up, up to 5 years
Overall Survival
Lasso di tempo: 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.
From treatment start to death or last follow-up, up to 5 years
Fistula Events
Lasso di tempo: 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.
From treatment start through 24 months and long-term follow-up, up to 5 years
Complete Response
Lasso di tempo: 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.
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
Lasso di tempo: 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 local progression or death, up to 5 years
Lasso di tempo: From treatment completion to regional progression or death, up to 5 years
Time from treatment completion to regional nodal recurrence or progression, or death.
From treatment completion to regional progression or death, up to 5 years
Distant Metastasis-Free Survival
Lasso di tempo: 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.
From treatment completion to event or last follow-up, up to 5 years
Freedom From Oligometastatic Reccurence/Progression
Lasso di tempo: 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.
From treatment completion to event or last follow-up, up to 5 years
Freedom From Polymetastatic Recurrence/Progression
Lasso di tempo: 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.
From treatment completion to polymetastatic progression, up to 5 years
Pattern of First Failure
Lasso di tempo: 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.
From treatment completion to first progression, up to 5 years

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Pelvic Exenteration-Free Survival
Lasso di tempo: From treatment completion to pelvic exenteration or death, up to 5 years.
Time from completion of reirradiation and/or total ablative strategy to pelvic exenteration or death, assessed in selected pelvic recurrence cohorts where applicable.
From treatment completion to pelvic exenteration or death, up to 5 years.
Systemic Therapy-Free Survival
Lasso di tempo: From treatment completion to initiation or escalation of systemic therapy, up to 5 years.
Time from completion of reirradiation and/or total ablative strategy to initiation or escalation of systemic anticancer therapy, assessed as an exploratory endpoint where clinically applicable.
From treatment completion to initiation or escalation of systemic therapy, up to 5 years.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Affidea Nu-med Center of Oncological DIagnostics and Therapy

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

11 giugno 2026

Completamento primario (Stimato)

1 dicembre 2031

Completamento dello studio (Stimato)

1 dicembre 2036

Date di iscrizione allo studio

Primo inviato

11 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

20 giugno 2026

Primo Inserito (Effettivo)

24 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • REGYNE(RA)DIATION

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Malattie rare

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