TY - JOUR
T1 - The RAZOR (randomized open vs robotic cystectomy) trial
T2 - Study design and trial update
AU - Smith, Norm D.
AU - Castle, Erik P.
AU - Gonzalgo, Mark L.
AU - Svatek, Robert S.
AU - Weizer, Alon Z.
AU - Montgomery, Jeffrey S.
AU - Pruthi, Raj S.
AU - Woods, Michael E.
AU - Tollefson, Matthew K.
AU - Konety, Badrinath R.
AU - Shabsigh, Ahmad
AU - Krupski, Tracey
AU - Barocas, Daniel A.
AU - Dash, Atreya
AU - Quek, Marcus L.
AU - Kibel, Adam S.
AU - Parekh, Dipen J.
N1 - Publisher Copyright:
© 2014 The Authors. BJU International © 2014 BJU International.
PY - 2015/2/1
Y1 - 2015/2/1
N2 - 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.
AB - 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.
KW - bladder cancer
KW - clinical trials
KW - cystectomy
KW - robotics
UR - http://www.scopus.com/inward/record.url?scp=84921461503&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84921461503&partnerID=8YFLogxK
U2 - 10.1111/bju.12699
DO - 10.1111/bju.12699
M3 - Article
C2 - 25626182
AN - SCOPUS:84921461503
VL - 115
SP - 198
EP - 205
JO - British Journal of Urology
JF - British Journal of Urology
SN - 1464-4096
IS - 2
ER -
