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

• Status: Recruiting
• Trial end date: 2027-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Regina Elena Cancer Institute
• Treatments: Cisplatin

Criteria

Inclusion Criteria:

• diagnostic TURBt with cT2-4, cN0, cM0;

• non-radiologic or endoscopic residual tumor after a maximal TURBt (cT0);

• patients eligible to curative intent, candidate to surgical treatment and/or NAC (all patients must meet all the criteria required to be able to undergo RC and/or NAC);

• ≥ 18 yrs old;

• compliants patients able to follow the study protocol and fill in EORTC quality of life questionnaires;

• patients able to provide a written informed consent for the trial

Exclusion criteria:

• anaesthesiologic contraindications to surgery;

• palliative intent;

• patients ineligible for cisplatin-combination chemotherapy