Patients older than ≥18 years, with muscle-invasive bladder cancer unfit for radical cystectomy because of age, comorbidities, and/or patient's refusal. This study is designed as a multicentre, single-arm phase II study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
79
Atezolizumab after adjuvant radio-chemotherapy for the treatment of patients with muscle-invasive bladder cancer not eligible for radical cystectomy
Institut Bergonie
Bordeaux, France
Centre Jean Perrin
Clermont-Ferrand, France
Centre Georges Francois Leclerc
Dijon, France
Centre Oscar Lambret
Disease Free Survival
Disease Free Survival is defined as the delay between date of inclusion and tumour relapse (local, regional, or distant) or death from any cause, whichever occurs first.
Time frame: 2 years
Local control rate
Local control rate will be evaluated by cystoscopy. The presence of non-muscle-invasive or muscle-invasive bladder cancers will be considered as a local failure. To be defined as locally controlled, the bladder must be completely free of tumour.
Time frame: 2 years
Local control rate
Local control rate will be evaluated by cystoscopy. The presence of non-muscle-invasive or muscle-invasive bladder cancers will be considered as a local failure. To be defined as locally controlled, the bladder must be completely free of tumour.
Time frame: 5 years
Disease Free Survival
Disease Free Survival is defined as the delay between date of inclusion and tumour relapse (local, regional, or distant) or death from any cause, whichever occurs first.
Time frame: 5 years
Overall Survival
Overall Survival is defined as the delay between the date of inclusion and the date of death, from any cause.
Time frame: 2 years
Overall Survival
Overall Survival is defined as the delay between the date of inclusion and the date of death, from any cause.
Time frame: 5 years
Incidence of Treatment-Emergent Adverse Events
The tolerance and safety will be evaluated by toxicity (acute \[\<6 months after the start of atezolizumab\] and late \[≥6 months after the start of atezolizumab\]), assessed using the NCI CTCAE v5.0
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Lille, France
Icm Val D'Aurelle
Montpellier, France
Centre Azureen de Cancerologie
Mougins, France
Centre Antoine Lacassagne
Nice, France
Hopital Saint Louis
Paris, France
Hôpital Pitie Salpetriere
Paris, France
Chu Lyon Sud
Pierre-Bénite, France
...and 2 more locations
Time frame: 2 years
Incidence of Treatment-Emergent Adverse Events
The tolerance and safety will be evaluated by toxicity (acute \[\<6 months after the start of atezolizumab\] and late \[≥6 months after the start of atezolizumab\]), assessed using the NCI CTCAE v5.0
Time frame: 5 years
Quality of Life Core Questionnaire - Cancer Patients (QLQ-C30)
Quality of life
Time frame: 5 years
Quality of Life Core Questionnaire - Bladder Cancer Muscle Invasive (QLQ-BLM30)
Quality of Life
Time frame: 5 years
Quality of Life Core Questionnaire - Elderly Cancer Patients (QLQ-ELD14)
Quality of Life
Time frame: 5 years
G8 oncodage
Quality of Life
Time frame: 5 years