NCT05776758Active, not recruitingPhase 3
Role of NAC in cT0 Muscle-invasive Bladder Cancer After Maximal TURBt
Neoadjuvant Chemotherapy Plus Cystectomy vs Cystectomy Alone for cT0 Muscle-invasive Bladder Cancer After Maximal TURBt: Multicentre Prospective Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 17 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 236 (estimated)
- First submitted
- 31 Jan 2023
- Start date
- 13 Aug 2026
- Primary completion date
- Jan 2028
- Lead sponsor
- Regina Elena Cancer Institute
- Diseases
- Bladder cancer
- NCT number
- NCT05776758
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 236
- From 13 Aug 2026 to the primary completion date, Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- anaesthesiologic contraindications to surgery;
- patients ineligible for cisplatin-combination chemotherapy
Other
- palliative intent;
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Riccardo Mastroianni Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.