NCT07008833

Radical CystEctomy or RaDio-chEMotherapy as Preferred Treatment for invasivE blaDder Cancer

Randomized, Non-inferiority Study Comparing Radiochemotherapy Versus Radical Cystectomy in Patients With Muscle-invasive Bladder Cancer

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 336 (estimated)
• Sponsor: Brazilian Clinical Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Your text is mostly clear and well-structured. Here's a slightly polished version for improved clarity and flow: This is a randomized, non-inferiority study comparing radiochemotherapy to radical cystectomy in patients with muscle-invasive bladder cancer. The primary outcome is the evaluation of the non-inferiority of metastasis-free survival between the two treatments. The study population includes individuals of both sexes, aged 18 years and older, diagnosed with pure or predominant urothelial carcinoma. Participants will be randomized in a 1:1 ratio, with Arm 1 receiving maximal TURBT followed by neoadjuvant chemotherapy and radiotherapy, and Arm 2 receiving TURBT followed by neoadjuvant chemotherapy with cisplatin, followed by radical cystectomy and bilateral pelvic lymphadenectomy.

Conditions

• Muscle Invasive Bladder Cancer

Interventions

Type	Name	Description
PROCEDURE	Radiochemotherapy	Maximum TURBT will be followed by neoadjuvant chemotherapy with cisplatin at a dose of 35 mg/m². After 2-6 weeks of neoadjuvant chemotherapy, patients will receive radiotherapy for 4 weeks, with concomitant cisplatin at a dose of 40 mg/m² weekly.
PROCEDURE	Radical cystectomy	TURBT will be followed by neoadjuvant chemotherapy with cisplatin at a dose of 35 mg/m², followed by radical cystectomy, bilateral pelvic lymphadenectomy, and reconstruction with either a Bricker procedure or a neobladder.

Timeline

• Start date: 2026-06-01
• Primary completion: 2031-12-01
• Completion: 2032-02-01
• First posted: 2025-06-06
• Last updated: 2026-02-12

Locations

1 site across 1 country: Brazil