Radiotherapy for Gynecologic Cancer With Up to 10 Active Metastatic Lesions

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.