Muscle-invasive bladder cancer
Conditions
Brief summary
Disease-free survival (DFS) will be assessed at 2 years. DFS is defined as the delay between date of inclusion, and tumour progression (local, regional, or distant) or death of any cause, whichever occurs first.
Detailed description
Local control rate will be evaluated by cystoscopy at 2 and 5 years. The presence of nonmuscle- 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. Duration of local control will be calculated from the date of inclusion till the date of positive cystoscopy. In case of regional or distant relapse occurring before local relapse, data will be censored at the time of relapse., Disease-free survival (DFS) will be assessed at 5 years. DFS is defined as the delay between date of inclusion, and tumour progression (local, regional, or distant) or death of any cause, whichever occurs first., Overall Survival (OS) will be assessed at 2 and 5 years. OS is defined as the delay between the date of inclusion and the date of death, of any cause., The tolerance and safety will be evaluated by toxicity: acute (<6 months after the start of treatment) and late (≥6 months after the start of treatment), assessed using the NCI CTCAE v5.0 (see Appendix 2). The tolerance will be evaluated up until 5 years., Quality of life
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival (DFS) will be assessed at 2 years. DFS is defined as the delay between date of inclusion, and tumour progression (local, regional, or distant) or death of any cause, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Local control rate will be evaluated by cystoscopy at 2 and 5 years. The presence of nonmuscle- 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. Duration of local control will be calculated from the date of inclusion till the date of positive cystoscopy. In case of regional or distant relapse occurring before local relapse, data will be censored at the time of relapse., Disease-free survival (DFS) will be assessed at 5 years. DFS is defined as the delay between date of inclusion, and tumour progression (local, regional, or distant) or death of any cause, whichever occurs first., Overall Survival (OS) will be assessed at 2 and 5 years. OS is defined as the delay between the date of inclusion and the date of death, of any cause., The tolerance and safety will be evaluated by toxicity: acute (<6 months after the start of treatment) and late (≥6 months after the start of tr | — |
Countries
France