Planned Safety Analysis of the ACTS-CC 02 Trial: A Randomized Phase III Trial of S-1 With Oxaliplatin Versus Tegafur and Uracil With Leucovorin as Adjuvant Chemotherapy for High-Risk Stage III Colon Cancer

摘要

To our knowledge, no phase III study has reported the safety of adjuvant chemotherapy with SOX (S-1 with oxaliplatin) in patients with colorectal cancer. We report the results of a planned safety analysis of the ACTS-CC 02 trial (Randomized phase III study of S-1/Oxaliplatin comparing Tegafur-Uracil/Leucovorin in the Adjuvant Chemotherapy of Stage IIIb Colorectal Cancer), which was a randomized phase III trial of SOX versus tegafur and uracil with leucovorin. The incidence of adverse events associated with SOX was acceptable.