Randomized Trial of Standard Care With or Without Metastases-directed Stereotactic Body Radiation Therapy in Patients With Oligometastatic Urothelial Carcinoma

What this Trial Is About

Bladder cancer is a common type of urothelial cancer that often has a poor outlook when it spreads to other parts of the body, known as metastatic disease. Current standard treatments include systemic therapies like chemotherapy and immune checkpoint inhibitors, which affect the whole body. This research is investigating whether stereotactic radiotherapy, a precise radiation technique delivering high doses in few sessions, can be effective and safe for treating limited metastatic bladder cancer (oligometastases). Participants will be randomly assigned to one of two groups: one receiving the usual systemic treatment alone, and the other receiving systemic treatment combined with stereotactic body radiation therapy (SBRT) targeted at the metastatic lesions. SBRT is used to focus radiation on a few metastases and is already common in treating oligometastases from other cancers. The study will follow patients from treatment through 12 months after. Throughout the study, researchers will monitor patients' response to the SBRT treatment, any side effects, quality of life, and immune system responses. Assessments will occur from the time of treatment up to one year later. The study aims to understand if adding SBRT to systemic therapy improves outcomes for patients with oligometastatic bladder cancer, with participation lasting through the follow-up period.

Randomized Trial of stAndard of Care With or Without Metastases-directed Stereotactic Body Radiation Therapy in Patients Affected by Oligometastatic uRothelial carcinomA