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

20 juin 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

500

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Pologne
    • Lublin Voivodeship
      • Zamość, Lublin Voivodeship, Pologne, 22-400
        • Recrutement
        • Affidea Nu-med Center of Oncological DIagnostics and Therapy
        • Contact:
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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.
Radiation: 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.
Autre: 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
Radiation: 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.
Autre: 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.
Radiation: 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.
Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Radiographic Progression-Free Survival
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Severe Treatment-Related Adverse Events
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Pelvic Exenteration-Free Survival
Délai: 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
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Affidea Nu-med Center of Oncological DIagnostics and Therapy

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

11 juin 2026

Achèvement primaire (Estimé)

1 décembre 2031

Achèvement de l'étude (Estimé)

1 décembre 2036

Dates d'inscription aux études

Première soumission

11 juin 2026

Première soumission répondant aux critères de contrôle qualité

20 juin 2026

Première publication (Réel)

24 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

24 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

20 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • REGYNE(RA)DIATION

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime 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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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