Radiotherapy for Gynecologic Cancer With Up to 10 Active Metastatic Lesions

Condition(s) studied

Investigational drug(s) / intervention(s)

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 SBRT/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.

Study 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 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.

Eligibility

Primary outcome measure(s)

• Radiographic progression-free survival (rPFS) — From the first qualifying radiotherapy fraction or brachytherapy application (T0-RT), assessed for up to 5 years.
  Time from 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.

Trial sites (1)

More Affidea Nu-med Center of Oncological DIagnostics and Therapy trials in Poland

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