Ongoing Colorectal Cancer Adjuvant Trials in Japan

In Japan, oral fluoropyrimidines have been used widely as adjuvant therapy for colorectal cancers. The 2009 Japanese guideline recommends uracil-tegafur (UFT) and capecitabine, in addition to 5-fluorouracil (5-FU)/leucovorin (LV), as adjuvant therapy for colorectal cancer. At present, seven studies are being conducted in Japan; all are evaluating the efficacy of oral fluoropyrimidines. The SACURA and Japanese Foundation for Multidisciplinary Treatment of Cancer (JFMC)38-0901 trials are investigating the efficacy of UFT and UFT plus polysaccharide K compared with surgery alone for stage II colorectal cancer. The Japan Clinical Oncology Group (JCOG)-0205 trial is evaluating the equivalence of UFT/LV and infusional 5-FU/LV for the treatment of stage III colorectal cancer. The ACTS-CC trial is evaluating the noninferiority of S-1 compared with UFT/LV, whereas the JFMC35-C1 (ACTS-RC) trial is designed to evaluate the superiority of oral S-1 compared with UFT/LV in stage II and III rectal cancer patients. The JFMC37-0801 and JFMC33-0502 trials are evaluating the optimal duration of adjuvant chemotherapy with either capecitabine or UFT/LV.