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RECRUITING

NCT07883798

Radiotherapy for Gynecologic Cancer With Up to 10 Active Metastatic Lesions

Sponsor: Affidea Nu-med Center of Oncological DIagnostics and Therapy

View on ClinicalTrials.gov

Summary

OLIGYNE-10 RT is an international registry of adults with gynecologic cancer and a limited number of active sites of cancer spread who receive radiotherapy (RT) to at least one metastatic lesion during routine care. The registry combines information from existing medical records with information collected prospectively. Treating clinical teams choose radiotherapy, imaging, systemic treatment, and follow-up. The registry does not assign treatment or require additional imaging or visits. The classical cohort includes people with 1 to 5 active metastatic lesions assessed by computed tomography (CT) or magnetic resonance imaging (MRI), with or without positron emission tomography (PET). An extended, exploratory cohort includes people with 6 to 10 active metastatic lesions assessed by qualifying fluorodeoxyglucose (FDG) positron emission tomography (PET) with computed tomography (CT) or magnetic resonance imaging (MRI). Eligible cancers include cervical, endometrial and other uterine cancers, uterine sarcomas, ovarian and fallopian tube cancers, primary peritoneal cancers, vulvar and vaginal cancers, and other eligible rare gynecologic cancers. The main objective is to describe the time from the first qualifying radiotherapy session or brachytherapy application until imaging shows cancer progression at any site or the participant dies. Other objectives include describing the control of treated lesions, patterns of cancer progression, survival, side effects, subsequent treatment of metastases, and how radiotherapy relates to the continuation or change of systemic treatment. The initial target is 500 participants, with possible expansion to at least 1,000. Follow-up is planned for up to five years using information available from routine care.

Official title: OLIGYNE-10 RT: An International, Multicenter, Ambispective Observational Registry of Radiotherapy for Oligometastatic Gynecologic Cancers With Up to 10 Active Metastatic Lesions, Stratified by Positron Emission Tomography (PET) Imaging

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

500

Start Date

2026-10-06

Completion Date

2036-12

Last Updated

2026-10-23

Healthy Volunteers

Conditions

Cervical Cancer Gynecologic Cancer Endometrial Cancer Uterine Cancer Uterine Sarcoma Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer Vulvar Cancer Vaginal Cancer

Interventions

RADIATION

Routine-care metastasis-directed radiotherapy

Qualifying radiotherapy delivered as routine clinical care to at least one active metastatic lesion, with radical, consolidative, or metastasis-directed intent for durable local control. Eligible modalities include stereotactic body radiotherapy (SBRT) / stereotactic ablative radiotherapy (SABR), stereotactic or hypofractionated external beam radiotherapy, conventional metastasis-directed external beam radiotherapy, brachytherapy, proton therapy, and qualifying combinations. Reirradiation is permitted. The treating team determines the indication, technique, dose, fractionation, target selection, treatment sequence, and any systemic treatment. The registry observes and records care; it does not assign or randomize treatment, prescribe a dose, or mandate additional imaging, visits, or other clinical procedures.

Inclusion Criteria: * Age at least 18 years at the reference eligibility date: at signing of consent/prospective enrollment, or at the first qualifying radiotherapy fraction or brachytherapy application (T0-RT) for historical and ambispective cohorts. * Histologically confirmed primary gynecologic malignancy. Biopsy of every metastatic lesion is not required if its nature is unequivocal clinically and on imaging, or confirmed by the multidisciplinary team. * One to 10 active metastatic lesions at the qualifying assessment, subject to the protocol imaging strata. The extended positron emission tomography (PET) core cohort with 6-10 lesions requires qualifying fluorodeoxyglucose (FDG) positron emission tomography (PET) with computed tomography (CT) or magnetic resonance imaging (MRI). * For the radiotherapy-treated core population: receipt of at least one qualifying radiotherapy fraction or brachytherapy application to an active metastatic lesion, with radical, consolidative or metastasis-directed intent. Before radiotherapy starts, only screening registration is possible. * Availability of the date of the qualifying oligometastatic disease assessment (T0-OMD), T0-RT, lesion number and location, and systemic strategy data; for historical cohorts, at least one follow-up outcome or vital-status observation. * For the prospective cohort: ability to provide informed consent and a signed consent form before the first qualifying radiotherapy fraction or brachytherapy application. Exclusion Criteria: * No confirmed gynecologic malignancy. * Surgery, ablation or systemic therapy alone without qualifying radiotherapy to a metastatic lesion. * Radiotherapy solely for symptom relief without intent to achieve durable control of the treated lesion, if it does not meet the metastasis-directed therapy (MDT) criteria specified in the analysis plan. * More than 10 active metastatic lesions or diffuse/uncountable disease at T0-OMD, for the core analysis. * A prospective case with 6-10 lesions without qualifying FDG PET/CT or FDG PET/MRI cannot enter the extended PET core cohort. It may enter only a separate exploratory module if otherwise eligible. * Lack of minimum data that prevents determination of eligibility, T0-RT or outcome. * No informed consent in the prospective cohort.

Locations (1)

Affidea NU-MED Centrum Diagnostyki i Terapii Onkologicznej

Zamość, Poland