๐ฌIn plain words
What the trial is, and whether it could suit you
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 magn
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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.
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What it tests
- Routine-care metastasis-directed radiotherapy
Affidea NU-MED Centrum Diagnostyki i Terapii Onkologicznej
Zamoลฤ, Poland
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.
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