locally advanced urothelial cancer.
Conditions
Brief summary
Pathological complete response rate, defined as the proportion of patients without residual UC in the surgical resection specimen, ypT0N0 (carcinoma situ is allowed), in the intention-to-treat analysis.
Detailed description
Progression-free, cancer-specific and overall survival at 24 months, calculated from the time of 1st administration of avelumab., Safety and tolerability of preoperative avelumab as assessed by the CTCAE v5.0 (Appendix 9)., Clavien-Dindo surgical complications (within 30 and 90 days from date of surgery) (Appendix 10)., The rate of non-invasive urothelial cancer in the surgical resection specimen, stage ypT0N0/ypTisN0/ypTaN0/ypT1N0., The proportion of patients in whom radical surgery is delayed >8 weeks after last administration of avelumab due to toxicity.
Interventions
Sponsors
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate, defined as the proportion of patients without residual UC in the surgical resection specimen, ypT0N0 (carcinoma situ is allowed), in the intention-to-treat analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free, cancer-specific and overall survival at 24 months, calculated from the time of 1st administration of avelumab., Safety and tolerability of preoperative avelumab as assessed by the CTCAE v5.0 (Appendix 9)., Clavien-Dindo surgical complications (within 30 and 90 days from date of surgery) (Appendix 10)., The rate of non-invasive urothelial cancer in the surgical resection specimen, stage ypT0N0/ypTisN0/ypTaN0/ypT1N0., The proportion of patients in whom radical surgery is delayed >8 weeks after last administration of avelumab due to toxicity. | — |
Countries
Netherlands
Outcome results
None listed