Statistical analysis
UC
Historically, the pCR rate following induction chemotherapy in patients with cT4NxM0 or cTxN1-N3M0 UC is 15% [An interim analysis to assess efficacy and safety is planned after inclusion of the first 40 patients (75% of the total accrual). If the pCR in the first 40 subjects is less than 15%, the study will terminate prematurely. A data safety monitoring committee (DSMB) was installed to ensure the safety of the participants and the validity and integrity of safety data generated from the study. The study is open for inclusion since December 2022 and the estimated final inclusion date is December 2024. All data will be prospectively collected.