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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
Consolidative radiotherapy (pelvic irradiation and/or metastases irradiation) + standard of care +/- previous transurethral resection of bladder tumor
Clinique Claude Bernard
Albi, France
RECRUITINGInstitut de Cancerologie de L'Ouest
Angers, France
RECRUITINGCHU Besançon
Besançon, France
RECRUITINGInstitut Bergonie
Bordeaux, France
RECRUITINGCHRU Brest
Brest, France
RECRUITINGClinique Pasteur-Lanroze
Brest, France
RECRUITINGCentre Francois Baclesse
Caen, France
RECRUITINGCentre Jean Perrin
Clermont-Ferrand, France
WITHDRAWNInstitut Andrée Dutreix
Dunkirk, France
RECRUITINGCentre Oscar Lambret
Lille, France
WITHDRAWN...and 10 more locations
Overall Survival
Time frame: 4 years for each patient
Progression Free Survival
Time frame: 4 years for each patient
Safety will be assessed by the toxicity grading of the National Cancer Institute (NCI-CTCAE v5)
Time frame: 4 years for each patient
Quality of life will be evaluated by the EORTC QLQ-C-30 questionnaire
Time frame: 4 years for each patient
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