NCT07883798 Radiotherapy for Gynecologic Cancer With Up to 10 Active Metastatic Lesions
| NCT ID | NCT07883798 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Affidea Nu-med Center of Oncological DIagnostics and Therapy |
| Condition | Cervical Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2026-10-06 |
| Primary Completion | 2036-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2026-10-06 with a primary completion date of 2036-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Mateusz Bilski, MD, PhD
PRINCIPAL INVESTIGATOR
Affidea NU-MED Centrum Diagnostyki i Terapii Onkologicznej, Zamosc, Poland
Frequently Asked Questions
Who can join the NCT07883798 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cervical Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07883798 currently recruiting?
Yes, NCT07883798 is actively recruiting participants. Contact the research team at bilskimat@gmail.com for enrollment information.
Where is the NCT07883798 trial being conducted?
This trial is being conducted at Zamość, Poland.
Who is sponsoring the NCT07883798 clinical trial?
NCT07883798 is sponsored by Affidea Nu-med Center of Oncological DIagnostics and Therapy. The principal investigator is Mateusz Bilski, MD, PhD at Affidea NU-MED Centrum Diagnostyki i Terapii Onkologicznej, Zamosc, Poland. The trial plans to enroll 500 participants.
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