Radiotherapy for gynecologic cancer with up to 10 metastatic sites

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

OLIGYNE-10 RT is an international, noninterventional registry that collects data from medical records and prospective follow-up for adults receiving radiotherapy to at least one metastatic lesion. Treating clinicians decide on radiotherapy, imaging, systemic therapy, and follow-up; the registry does not assign treatments or require extra visits. Participants are grouped into a classical cohort (1–5 lesions) and an exploratory cohort (6–10 lesions) based on imaging, with eligibility including gynecologic cancers such as cervical and endometrial tumors. Data come from historical records, routine care follow-up, and prospective enrollment, with consent required before the first qualifying radiotherapy fraction. The study aims to describe real-world patterns and outcomes of metastasis-directed radiotherapy in this patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Affidea NU-MED Centrum Diagnostyki i Terapii Onkologicznej
  Zamość, Poland Recruiting

Study contacts

• Principal investigator: Mateusz Bilski, MD, PhD — Affidea NU-MED Centrum Diagnostyki i Terapii Onkologicznej, Zamosc, Poland
• Study coordinator: Mateusz Bilski, MD, PhD
• Email: bilskimat@gmail.com
• Phone: +48 84 5359910

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.