Clinical Trial

Role of NAC in cT0 Muscle-invasive Bladder Cancer After Maximal TURBt

Active, Not Recruiting Phase 3
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Record status
This record was last updated April 16, 2025 (before its estimated January 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-03-08; most recent amendment 2025-04-11.
Status change: Recruiting → Active, Not Recruiting 2024-11-29
Trial Details
NCT Number NCT05776758
Lead Sponsor Regina Elena Cancer Institute
Conditions Muscle-Invasive Bladder Carcinoma, Chemotherapy Effect, Surgery
Enrollment 236 participants
Start Date 2024-11-29
Primary Completion 2026-01 (estimated)
Study Completion 2027-01 (estimated)
Updated on ClinicalTrials.gov 2025-04-16