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

NCT07008833 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 336

Last updated 2026-02-12

No results posted yet for this study

Summary

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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

Interventions

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.

Sponsors & Collaborators

  • Ministry of Science and Technology, Brazil

    collaborator OTHER

  • Brazilian Clinical Research Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2031-12-31
Completion
2032-02-29

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07008833 on ClinicalTrials.gov