An observational study in Cervical Cancer, Gynecologic Cancer and Endometrial Cancer, sponsored by Affidea Nu-med Center of Oncological DIagnostics and Therapy. Recruiting at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Affidea Nu-med Center of Oncological DIagnostics and Therapy · Observational
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.
OLIGYNE-10 RT is an investigator-initiated, international, multicenter, noninterventional master registry. All treatment decisions remain with the treating clinical teams. Qualifying radiotherapy (RT) 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 fluorodeoxyglucose (FDG) positron emission tomography (PET) with computed tomography (CT) or magnetic resonance imaging (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.
1,927 studies on the registry are indexed under Uterine Cervical Neoplasms; 576 are open to participants now.
This study's planned enrollment of 500 is above the median of 220 across 429 observational studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Affidea Nu-med Center of Oncological DIagnostics and Therapy is the lead sponsor of 6 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults with histologically confirmed gynecologic malignancies and qualifying oligometastatic episodes who receive radiotherapy to at least one active metastatic lesion at participating international centers. The registry combines historical retrospective, ambispective and prospective data. The core includes 1-5 active lesions assessed by computed tomography (CT) or magnetic resonance imaging (MRI) with or without positron emission tomography (PET), and an extended, hypothesis-generating cohort with 6-10 active lesions confirmed by qualifying fluorodeoxyglucose (FDG) PET/CT or FDG PET/MRI. Cases with 6-10 lesions without qualifying PET are kept in a separate exploratory module and are not pooled with the extended PET cohort.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Eligible adults with gynecologic cancer whose qualifying radiotherapy (RT) for the index oligometastatic episode was completed before registry activation at the participating center. All data up to the relevant cutoff are obtained retrospectively from existing clinical records, radiotherapy planning systems, and archived imaging. Entry into the RT-treated core cohort requires at least one qualifying radiotherapy fraction or brachytherapy application to an active metastatic lesion.
Radiation: Routine-care metastasis-directed radiotherapy
Eligible adults with gynecologic cancer whose qualifying radiotherapy (RT) for the index oligometastatic episode began before registry activation or enrollment. Baseline and treatment information are reconstructed retrospectively, while subsequent updates are limited to information generated during routine clinical care. Entry into the RT-treated core cohort requires at least one qualifying radiotherapy fraction or brachytherapy application to an active metastatic lesion. The registry does not require additional clinical visits or imaging.
Radiation: Routine-care metastasis-directed radiotherapy
Eligible adults with gynecologic cancer screened after activation of the prospective registry component. Written informed consent and baseline data collection occur before the first qualifying radiotherapy (RT) fraction or brachytherapy application for the index oligometastatic episode. Participants enter the RT-treated core cohort only after qualifying radiotherapy to an active metastatic lesion has actually begun. Treatment and clinical follow-up are selected by the treating team as routine care; the registry does not assign treatment.
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.
Radiographic progression-free survival (rPFS)
Time from the first qualifying radiotherapy fraction or brachytherapy application (T0-RT) to first radiographic progression at any site or death from any cause. Participants without an event are censored at the last reliable radiographic assessment. Clinical progression without imaging is recorded separately and considered in sensitivity analyses.
Time frame: From the first qualifying radiotherapy fraction or brachytherapy application (T0-RT), assessed for up to 5 years.
Polymetastatic progression-free survival: classical threshold (PMFS-C5)
Time from the first qualifying radiotherapy fraction or brachytherapy application (T0-RT) to more than 5 total active metastatic lesions, diffuse or uncountable disease, or death. Evaluated only in participants with 1-5 active metastatic lesions at the qualifying oligometastatic disease assessment (T0-OMD). The threshold uses total active metastatic burden, not only newly detected lesions.
Time frame: From the first qualifying radiotherapy fraction or brachytherapy application (T0-RT), assessed for up to 5 years.
Polymetastatic progression-free survival: extended threshold (PMFS-E10)
Time from the first qualifying radiotherapy fraction or brachytherapy application (T0-RT) to more than 10 total active metastatic lesions, diffuse or uncountable disease, or death. Evaluated in the positron emission tomography (PET)-defined cohort with 1-10 lesions. The expanded positron emission tomography-defined polymetastatic progression threshold (PMD-E10) status is indeterminate when follow-up imaging cannot assess the threshold, unless more than 10 lesions or diffuse disease is unequivocal.
Time frame: From the first qualifying radiotherapy fraction or brachytherapy application (T0-RT), assessed for up to 5 years.
Time to loss of the oligometastatic state (TLOMS)
Time from the first qualifying radiotherapy fraction or brachytherapy application (T0-RT) to loss of the oligometastatic state through progression to the applicable polymetastatic threshold or diffuse disease. Death is treated as a competing event in the disease-state estimand.
Time frame: From the first qualifying radiotherapy fraction or brachytherapy application (T0-RT), assessed for up to 5 years.
Systemic therapy start or switch-free survival (SST-FS)
Time from the first qualifying radiotherapy fraction or brachytherapy application (T0-RT) to initiation of systemic anticancer treatment, a change in treatment line, escalation of the systemic strategy, or death. Event rules depend on the baseline systemic-treatment setting.
Time frame: From the first qualifying radiotherapy fraction or brachytherapy application (T0-RT), assessed for up to 5 years.
Overall survival (OS)
Time from the first qualifying radiotherapy fraction or brachytherapy application (T0-RT) to death from any cause.
Time frame: From the first qualifying radiotherapy fraction or brachytherapy application (T0-RT), assessed for up to 5 years.
Treated-lesion local control
Time from the first radiotherapy fraction or brachytherapy application to the individual lesion to unequivocal in-field progression. Death without lesion progression is treated as a competing event. Lesions are assessed individually.
Time frame: From the first radiotherapy fraction or brachytherapy application to each lesion, assessed for up to 5 years.
Pattern of first progression
Description of first progression by anatomical site, number of active lesions, detection modality, local feasibility of subsequent metastasis-directed therapy, and oligometastatic or polymetastatic disease status.
Time frame: At first progression after the first qualifying radiotherapy fraction or brachytherapy application (T0-RT), during follow-up of up to 5 years.
Systemic therapy-free survival (STFS)
Among participants without active systemic treatment at the first qualifying radiotherapy fraction or brachytherapy application (T0-RT), time to initiation of any systemic anticancer treatment or death.
Time frame: From the first qualifying radiotherapy fraction or brachytherapy application (T0-RT), assessed for up to 5 years.
Time to next systemic therapy line (TTNSL)
Time from the first qualifying radiotherapy fraction or brachytherapy application (T0-RT) to the first new systemic treatment line after the index strategy. Continuation of a regimen started as part of the index strategy is not an event until treatment is changed or escalated.
Time frame: From the first qualifying radiotherapy fraction or brachytherapy application (T0-RT), assessed for up to 5 years.
Time to initiation or change of cytotoxic chemotherapy
Time from the first qualifying radiotherapy fraction or brachytherapy application (T0-RT) to initiation or change of cytotoxic chemotherapy. Continuation of non-cytotoxic treatment is not an event.
Time frame: From the first qualifying radiotherapy fraction or brachytherapy application (T0-RT), assessed for up to 5 years.
Maintenance treatment strategy preservation interval (MTPI)
Among participants receiving maintenance or continuing therapy, time from the first qualifying radiotherapy fraction or brachytherapy application (T0-RT) to permanent discontinuation, escalation or change of that strategy because of progression, an adverse event or a clinical decision. A temporary hold followed by resumption of the same therapy is not an event.
Time frame: From the first qualifying radiotherapy fraction or brachytherapy application (T0-RT), assessed for up to 5 years.
Time to subsequent metastasis-directed therapy (TTMDT)
Time from the first qualifying radiotherapy fraction or brachytherapy application (T0-RT) to subsequent metastasis-directed treatment, particularly a subsequent course of radiotherapy.
Time frame: From the first qualifying radiotherapy fraction or brachytherapy application (T0-RT), assessed for up to 5 years.
Complete response of treated lesions
Complete response assessed separately for treated lesions at approximately 3 and 6 months after completion of radiotherapy, according to local practice, preferably Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1), supplemented by metabolic criteria when positron emission tomography (PET) is used.
Time frame: Approximately 3 months (±6 weeks) and 6 months (±8 weeks) after completion of index radiotherapy.
Patient-level complete response
Complete response at participant level assessed at approximately 3 and 6 months after completion of radiotherapy, according to local practice, preferably Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1), supplemented by metabolic criteria when positron emission tomography (PET) is used.
Time frame: Approximately 3 months (±6 weeks) and 6 months (±8 weeks) after completion of index radiotherapy.
Acute adverse events
Acute adverse events characterized by term, grade, dates, seriousness, attribution, intervention, hospitalization, treatment interruption and outcome. Baseline events are recorded separately. The Common Terminology Criteria for Adverse Events, version 6.0 (CTCAE v6.0) are used for prospectively collected data; historical data retain the source version and are mapped only when reliable.
Time frame: From initiation of radiotherapy through 90 days after completion of index radiotherapy.
Late adverse events
Adverse events occurring more than 90 days after completion of radiotherapy, characterized by term, grade, dates, seriousness, attribution, intervention and outcome. The Common Terminology Criteria for Adverse Events, version 6.0 (CTCAE v6.0) are used for prospectively collected data; historical data retain the source version and are mapped only when reliable.
Time frame: More than 90 days after completion of index radiotherapy, assessed during follow-up of up to 5 years.
Disease-burden reclassification associated with positron emission tomography (PET)
Reclassification of the number of active metastatic lesions between 1-5, 6-10, and more than 10 or diffuse-disease categories after incorporating fluorodeoxyglucose positron emission tomography (FDG-PET). Paired computed tomography/magnetic resonance imaging (CT/MRI)-PET comparisons require scans no more than 28 days apart without intervening treatment that changes disease burden.
Time frame: At baseline, using computed tomography/magnetic resonance imaging (CT/MRI) and fluorodeoxyglucose positron emission tomography (FDG-PET) performed no more than 28 days apart, without intervening treatment that changes disease burden.
Management change associated with positron emission tomography (PET)
Positron emission tomography (PET)-associated changes in eligibility, treatment intent, target selection, radiation fields or systemic-treatment strategy for the index episode.
Time frame: During qualifying baseline staging and planning for the index radiotherapy strategy.
Discordance between conventional imaging and fluorodeoxyglucose positron emission tomography (FDG-PET)
Differences between computed tomography/magnetic resonance imaging (CT/MRI) and fluorodeoxyglucose positron emission tomography (FDG-PET) in the number and anatomical location of active metastatic lesions, assessed in the paired-imaging population.
Time frame: At baseline, using computed tomography/magnetic resonance imaging (CT/MRI) and fluorodeoxyglucose positron emission tomography (FDG-PET) performed no more than 28 days apart, without intervening treatment that changes disease burden.
Distant disease progression-free interval
Time from the first qualifying radiotherapy fraction or brachytherapy application (T0-RT) to the first radiographically documented new lesion or unequivocal progression of an existing lesion outside the prespecified disease-specific locoregional compartment. This includes progression of distant metastases present at baseline. Compartments are defined relative to the primary tumor, independently of the radiation fields.
Time frame: From the first qualifying radiotherapy fraction or brachytherapy application (T0-RT), assessed for up to 5 years.
Locoregional disease progression-free interval
Time from the first qualifying radiotherapy fraction or brachytherapy application (T0-RT) to the first radiographically documented new lesion or unequivocal progression within the primary tumor or operative bed and the regional nodal basins prespecified for the primary gynecological site. Locoregional status is anatomical and is not defined by whether a lesion lies within a radiation field.
Time frame: From the first qualifying radiotherapy fraction or brachytherapy application (T0-RT), assessed for up to 5 years.
Time to deterioration in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) global health status/quality of life
Only where the optional patient-reported outcome (PRO) module has been approved and activated, and the required participant consent has been obtained, time from the first qualifying radiotherapy fraction or brachytherapy application (T0-RT) to the first observed decrease of at least 10 points from a valid pre-radiotherapy baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status/quality of life (QoL) scale (items 29-30; range 0-100; higher scores indicate better health/QoL). The event date is the questionnaire date; confirmation at a later assessment is not required.
Time frame: From the first qualifying radiotherapy fraction or brachytherapy application (T0-RT), assessed in the approved patient-reported outcome (PRO) module for up to 5 years.
Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) global health status/quality of life
Only where the optional patient-reported outcome (PRO) module has been approved and activated, and the required participant consent has been obtained, mean change from a valid pre-radiotherapy baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status/quality of life (QoL) scale (items 29-30; range 0-100), assessed separately at approximately 3 and 6 months after completion of radiotherapy. Positive change indicates improvement and negative change indicates deterioration. No binary preservation threshold is applied.
Time frame: Baseline before radiotherapy and approximately 3 months (±6 weeks) and 6 months (±8 weeks) after completion of index radiotherapy.
Patient-reported general pain and fatigue using Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Only where the optional patient-reported outcome (PRO) module has been approved and activated, and the required participant consent has been obtained, response-category distributions and changes from pre-radiotherapy baseline are reported separately for General pain frequency, severity and interference, and Fatigue severity and interference, using the five corresponding Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) items with a 7-day recall. No combined score, conversion to Common Terminology Criteria for Adverse Events (CTCAE) grades or clinically meaningful responder threshold is used.
Time frame: Baseline before radiotherapy and approximately 3 months (±6 weeks) and 6 months (±8 weeks) after completion of index radiotherapy; each questionnaire uses a 7-day recall.
Unplanned hospital and urgent-care use during the first 180 days
During the first 180 calendar days beginning on the first qualifying radiotherapy fraction or brachytherapy application (T0-RT), report separately per participant the number of unplanned inpatient admission episodes, urgent or unscheduled visits, and unique days spent in unplanned inpatient care. Transfers during one continuous inpatient stay do not constitute a new admission. Components are not combined into a single score.
Time frame: The first 180 calendar days beginning on the first qualifying radiotherapy fraction or brachytherapy application (T0-RT) (day 0 through day 179).
Days alive and out of hospital during the first 180 days (DAOH-180)
Number of calendar days alive and not in inpatient care during days 0-179 beginning on the first qualifying radiotherapy fraction or brachytherapy application (T0-RT); range 0-180. Both planned and unplanned inpatient stays count as hospital days. A day with any inpatient care counts once; outpatient-only visits do not subtract a day. The date of death and subsequent days contribute zero. A value is calculated only when vital status and inpatient dates are adequately documented.
Time frame: The first 180 calendar days beginning on the first qualifying radiotherapy fraction or brachytherapy application (T0-RT) (day 0 through day 179).
Plan to share: No — There is currently no plan to share individual participant data (IPD) outside the registry consortium. The principal investigator may consider individual requests for exploratory analyses in the future, subject to applicable consent, approvals and data-protection requirements. No data-sharing timetable, access criteria or commitment to provide IPD has been established.
Started Oct 2026 (actual). Primary completion is estimated for Dec 2036, 122 months after the start.
Of 148 non-industry observational studies under Uterine Cervical Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 174. This study's planned 122 months is above that.
Counting every sponsor, half of 164 studies reached it within 58 months; a quarter within 27 and three quarters within 174.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Affidea Nu-med Center of Oncological DIagnostics and Therapy