The RAZOR (randomized open vs robotic cystectomy) trial: study design and trial update

Area of Science:

• Urological oncology
• Surgical innovation
• Clinical trial design

Background:

• Bladder cancer treatment often involves radical cystectomy.
• Comparing open radical cystectomy (ORC) with robot-assisted radical cystectomy (RARC) is crucial for optimizing patient outcomes.
• The RAZOR trial addresses the need for evidence-based comparisons of these surgical approaches.

Purpose of the Study:

• To compare open radical cystectomy (ORC) versus robot-assisted radical cystectomy (RARC) in patients with bladder cancer.
• To evaluate oncological outcomes, surgical complications, and health-related quality of life (HRQL).
• To determine non-inferiority of RARC compared to ORC based on 2-year progression-free survival (PFS).

Main Methods:

• A multi-institutional, randomized, non-inferiority, phase III trial (RAZOR).
• Enrollment of at least 320 patients with T1-T4, N0-N1, M0 bladder cancer.
• Prospective data collection on cancer outcomes, complications, and HRQL, with final analysis by Cancer Research and Biostatistics (CRAB).

Main Results:

• The RAZOR trial is a landmark study in urological oncology.
• It randomizes patients with bladder cancer to either ORC or RARC, including pelvic lymph node dissection (PLND) and urinary diversion.
• Accrual is nearing completion, with over 306 patients randomized.

Conclusions:

• The RAZOR trial is designed to provide critical data on the comparative effectiveness of ORC and RARC.
• Findings will inform surgical decision-making and patient care in bladder cancer management.
• Full data are anticipated by 2016-2017, offering insights into oncological control, morbidity, and patient-reported outcomes.