High-Risk Non-muscle-invasive Bladder Cancer
Conditions
Brief summary
EFS will be measured as the time from randomization to either the time of the first recurrence of high-risk disease, progression, or death due to any cause, whichever occurs first. For participants with CIS, persistent disease at 6 months (Week 24) is also considered an EFS event. Progression is defined as: 1) an increase of stage from Ta to T1 or from CIS to T1, or 2) progression to MIBC (T≥2) or to lymph node (N+) or to distant disease (M+), whichever occurs first.
Interventions
Sponsors
Janssen - Cilag International
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EFS will be measured as the time from randomization to either the time of the first recurrence of high-risk disease, progression, or death due to any cause, whichever occurs first. For participants with CIS, persistent disease at 6 months (Week 24) is also considered an EFS event. Progression is defined as: 1) an increase of stage from Ta to T1 or from CIS to T1, or 2) progression to MIBC (T≥2) or to lymph node (N+) or to distant disease (M+), whichever occurs first. | — |
Countries
Belgium, Czechia, France, Germany, Italy, Netherlands, Poland, Portugal, Spain
Outcome results
None listed