Consolidative Radiotherapy for Metastatic Urothelial Bladder Cancer Patients Without Progression and With no More Than Three Residual Metastatic Lesions Following First Line Systemic Therapy: a Prospective Randomized Comparative Phase II Trial

What this Trial Is About

Researchers are evaluating whether adding local consolidative radiotherapy to the standard treatment improves overall survival in patients with metastatic urothelial bladder cancer. This study focuses on patients who have no disease progression and have no more than three remaining distant metastatic lesions after completing first-line systemic therapy. It is a Phase II, randomized, open-label study conducted at multiple centers. Participants will be randomly assigned either to receive standard care alone or to receive consolidative radiotherapy targeting the pelvis and/or metastatic sites in addition to standard care. Some patients may have had a previous bladder tumor resection. The radiotherapy is given after the initial systemic treatment phase, which includes chemotherapy and/or immunotherapy. The study follows patients for four years from the time of randomization. During the study, patients will have regular assessments including imaging scans to check disease status, toxicity evaluations according to national criteria, and quality of life questionnaires using the EORTC QLQ-C-30 tool. Researchers will monitor overall survival and progression-free survival over four years. Patients must be able to participate and agree to follow the study procedures, and safety is closely observed throughout the trial.

Consolidative Radiotherapy for Metastatic Urothelial Bladder Cancer Patients Without Progression and With no More Than Three Residual Metastatic Lesions Following First Line Systemic Therapy