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.
Age ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Urothelial bladder cancer histologically proven (both pure urothelial cancers and mixed histologic features are allowed)
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)
Non-transitional cell histology (Squamous cell carcinoma, adenocarcinoma or neuroendocrine carcinoma of the bladder)
Brain metastases before systemic treatment
Liver metastases before systemic treatment
Absence of target to be irradiated (i.e. previous cystectomy + no residual distant lesions following systemic treatment + no pelvic or para-aortic nodes at metastatic presentation)
Parallel
Experimental arm
RadiationConsolidative radiotherapy (pelvic irradiation and/or metastases irradiation) + standard of care +/- previous transurethral resection of bladder tumor
Overall Survival
Progression Free Survival
Safety will be assessed by the toxicity grading of the National Cancer Institute (NCI-CTCAE v5)
Quality of life will be evaluated by the EORTC QLQ-C-30 questionnaire
Click on the lead sponsor to view all of their trials.
