Overview
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 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 FDG PET/CT or FDG PET/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.
Description
OLIGYNE-10 RT is an investigator-initiated, international, multicenter, noninterventional master registry. All treatment decisions remain with the treating clinical teams. Qualifying radiotherapy may include stereotactic radiotherapy, other external beam techniques, brachytherapy, proton therapy, reirradiation, or qualifying combinations. Surgery, thermal ablation, and systemic treatment may be part of a combined strategy, but treatment without qualifying radiotherapy does not establish eligibility for the radiotherapy-treated core cohort.
Participants are enrolled consecutively: all patients meeting eligibility criteria at participating centers during the applicable enrollment period are included.
Data acquisition combines historical retrospective records, ambispective routine-care follow-up, and prospective enrollment. Prospective participants provide written informed consent before the first qualifying radiotherapy fraction or brachytherapy application. Inclusion in the radiotherapy-treated core cohort requires delivery of at least one qualifying fraction or application. The registry distinguishes screening from the treated analysis population.
Imaging-based stratification separates classical oligometastatic disease with 1 to 5 active metastatic lesions from an extended, hypothesis-generating group with 6 to 10 lesions confirmed by qualifying FDG PET/CT or FDG PET/MRI. Cases with 6 to 10 lesions assessed without qualifying PET are considered only in a separate exploratory module and are not pooled with the extended PET cohort in the main analysis. Polymetastatic progression thresholds refer to the total active metastatic burden, not only the number of newly detected lesions.
The date of qualifying oligometastatic disease assessment (T0-OMD), the first qualifying radiotherapy fraction or brachytherapy application in the index episode (T0-RT), and lesion-specific treatment dates are recorded separately. Clinical scenarios, imaging, tumor characteristics, radiotherapy technique and dosimetry, systemic treatment strategy, treatment completeness, response, progression, adverse events, subsequent treatments, and vital status are collected. Data windows harmonize available routine-care information and do not mandate additional clinical visits or scans.
Analyses will account for the primary cancer, histology and molecular characteristics, oligometastatic disease scenario, disease burden, imaging, treatment context, and center. Historical and prospective cohorts will initially be reported separately for endpoints sensitive to documentation quality. Time-to-event, competing-risk, multivariable, multistate, propensity-score, landmark, and time-dependent analyses may be used as appropriate. Comparisons of systemic treatment strategies are observational and will be interpreted with consideration of confounding by indication.
Optional patient-reported outcome and translational modules require the applicable consent and separate approvals. The core registry does not mandate additional biospecimen collection or research imaging. Direct patient identifiers are not transferred to the central registry database; analyses and publications use pseudonymized or aggregate information.
Eligibility
Inclusion Criteria:
- Age at least 18 years at the reference eligibility date: at signing of consent/prospective enrollment, or at 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 PET core cohort with 6-10 lesions requires qualifying FDG PET/CT or FDG PET/MRI.
- For the RT-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 RT starts, only screening registration is possible.
- Availability of 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 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.
