title: The RAZOR (randomized open vs robotic cystectomy) trial: study design and trial update.
abstract: The purpose of the RAZOR (randomized open vs robotic cystectomy) study is to compare open radical cystectomy (ORC) vs robot-assisted RC (RARC), pelvic lymph node dissection (PLND) and urinary diversion for oncological outcomes, complications and health-related quality of life (HRQL) measures with a primary endpoint of 2-year progression-free survival (PFS). RAZOR is a multi-institutional, randomized, non-inferior, phase III trial that will enrol at least 320 patients with T1-T4, N0-N1, M0 bladder cancer with ≈160 patients in both the RARC and ORC arms at 15 participating institutions. Data will be collected prospectively at each institution for cancer outcomes, complications of surgery and HRQL measures, and then submitted to trial data management services Cancer Research and Biostatistics (CRAB) for final analyses. To date, 306 patients have been randomized and accrual to the RAZOR trial is expected to conclude in 2014. In this study, we report the RAZOR trial experimental design, objectives, data safety, and monitoring, and accrual update. The RAZOR trial is a landmark study in urological oncology, randomizing T1-T4, N0-N1, M0 patients with bladder cancer to ORC vs RARC, PLND and urinary diversion. RAZOR is a multi-institutional, non-inferiority trial evaluating cancer outcomes, surgical complications and HRQL measures of ORC vs RARC with a primary endpoint of 2-year PFS. Full data from the RAZOR trial are not expected until 2016-2017.
authors.affiliation: The University of Chicago, Chicago, IL, USA.
authors.forename: Norm D
authors.initials: ND
authors.lastname: Smith
authors.forename: Erik P
authors.initials: EP
authors.lastname: Castle
authors.forename: Mark L
authors.initials: ML
authors.lastname: Gonzalgo
authors.forename: Robert S
authors.initials: RS
authors.lastname: Svatek
authors.forename: Alon Z
authors.initials: AZ
authors.lastname: Weizer
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Montgomery
authors.forename: Raj S
authors.initials: RS
authors.lastname: Pruthi
authors.forename: Michael E
authors.initials: ME
authors.lastname: Woods
authors.forename: Matthew K
authors.initials: MK
authors.lastname: Tollefson
authors.forename: Badrinath R
authors.initials: BR
authors.lastname: Konety
authors.forename: Ahmad
authors.initials: A
authors.lastname: Shabsigh
authors.forename: Tracey
authors.initials: T
authors.lastname: Krupski
authors.forename: Daniel A
authors.initials: DA
authors.lastname: Barocas
authors.forename: Atreya
authors.initials: A
authors.lastname: Dash
authors.forename: Marcus L
authors.initials: ML
authors.lastname: Quek
authors.forename: Adam S
authors.initials: AS
authors.lastname: Kibel
authors.forename: Dipen J
authors.initials: DJ
authors.lastname: Parekh
mesh_terms: D017326:Clinical Trials, Phase III as Topic; D015653:Cystectomy / Q000009:adverse effects / Q000379:methods; D018572:Disease-Free Survival; D006304:Health Status; D006801:Humans; D008197:Lymph Node Excision / Q000009:adverse effects / Q000379:methods; D019060:Minimally Invasive Surgical Procedures; D015337:Multicenter Studies as Topic; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D065287:Robotic Surgical Procedures / Q000379:methods; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D014547:Urinary Diversion / Q000009:adverse effects / Q000379:methods
keywords: bladder cancer; clinical trials; cystectomy; robotics