Patients with non-metastatic muscle invasive bladder cancer
Conditions
Brief summary
The primary end point is one –year disease–free survival, which will be defined as the rate of survival free of recurrence in pelvic nodes or bladder (cis excluded), or appearance of distant metastasis with data censored at the first sign of disease or second primary tumor, or death
Detailed description
To describe the rate of patients who require salvage cystectomy, To describe the rate of locoregional complete response, To describe the rate of locoregional disease-free survival, To describe the median disease-free survival, To describe the median metastasis-free survival, To describe the safety of the combination of nivolumab plus cisplatin and nab-paclitaxel with concomitant RT, To describe the safety of nivolumab after RT, Quality of life
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end point is one –year disease–free survival, which will be defined as the rate of survival free of recurrence in pelvic nodes or bladder (cis excluded), or appearance of distant metastasis with data censored at the first sign of disease or second primary tumor, or death | — |
Secondary
| Measure | Time frame |
|---|---|
| To describe the rate of patients who require salvage cystectomy, To describe the rate of locoregional complete response, To describe the rate of locoregional disease-free survival, To describe the median disease-free survival, To describe the median metastasis-free survival, To describe the safety of the combination of nivolumab plus cisplatin and nab-paclitaxel with concomitant RT, To describe the safety of nivolumab after RT, Quality of life | — |
Countries
Italy