A Randomized Phase II Study of Oxaliplatin and S-1 (OS) Versus Oxaliplatin and Capecitabine (XELOX) in Patients With Advanced or Recurrent Colorectal Cancer
Oxaliplatin and oral fluoropyrimidines (capecitabine or S-1) are active agents for
colorectal cancer. Recent a phase II trial of combination chemotherapy of oxaliplatin with
S-1 (OS) and several phase II trial of combination chemotherapy of oxaliplatin with
capecitabine (XELOX) demonstrated good activity and mild toxicity in advanced colorectal
cancer. Oxaliplatin and S-1 or capecitabine have distinct mechanisms of action and no
overlap of key toxicities. Furthermore, oxaliplatin and fluorouracil were shown to be highly
synergistic, not only in preclinical models but also in subsequent clinical trials.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
overall response rate
4 years
No
Dae Young Zang, MD, PhD
Principal Investigator
Hallym University Medical Center
Korea: Food and Drug Administration
HMC-HO-GI-0712
NCT00677144
April 2008
April 2012
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