Consolidative Radiotherapy for Metastatic Urothelial Bladder Cancer Patients Without Progression and With no More Than Three Residual Metastatic Lesions Following First Line Systemic Therapy
Trial Parameters
Brief Summary
This is a Phase II, multicenter, randomized open-label and comparative study that has been designed to evaluate whether local consolidative radiotherapy in addition to standard of care improves overall survival as compared with standard of care in patients with regional and/or distant metastatic urothelial bladder cancer who have no disease progression and with no more than three residual distant metastatic lesions following the initial phase of first-line systemic therapy. Each patient will be followed during 4 years from the date of randomization.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years 2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 3. Urothelial bladder cancer histologically proven (both pure urothelial cancers and mixed histologic features are allowed) 4. Metastatic patients to regional nodes (Tx,N1-N3,M0) and/or distant sites (Tx,Nx,M1a-M1b) documented with contrast-enhanced CT-scanner of the chest, abdomen and pelvis, either de novo or presenting first regional/distant relapse following cystectomy (with no local recurrence in the cystectomy bed) 5. Completion of the initial phase (4-6 cycles) of 1st line metastatic treatment (systemic therapy by chemotherapy and/or immunotherapy by immune check-point inhibitor according to standard recommendations). Patients having started maintenance therapy are eligible. 6. No disease progression after the initial phase of first-line metastatic systemic therapy according to RECIST v1.1 7. No more than 3 residual distant metastatic lesions following the initial phase of f