Role of NAC in cT0 Muscle-invasive Bladder Cancer After Maximal TURBt
Status:
Recruiting
Trial end date:
2027-01-01
Target enrollment:
Participant gender:
Summary
This prospective randomized controlled trial (RCT) is designed to provide high level evidence
describing the non-inferiority of radical cystectomy (RC) alone versus neoadjuvant
chemotherapy (NAC) plus RC on survival outcomes of patients with a diagnostic transurethral
resection of bladder tumor (TURBt) of non-metastatic muscle invasive bladder cancer (MIBC)
(T2-T4 N0 M0) and non-radiologic or endoscopic residual tumor after a maximal TURBt (cT0).
Our hypothesis is that performing NAC in the absence of residual disease, after a maximal
TURBt, has no survival benefit over performing an early cystectomy. Since no downstaging
could be achieved in patients with no residual tumor into the bladder, the benefits of
neoadjuvant chemotherapy in this setting could be not significant and it might turn into
unnecessary toxicity and a substantial delay to surgical treatment.