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were orally administered; one course lasted 5 weeks, and 5 courses were administered. The primary endpoint was disease-free survival (DFS). The secondary endpoints were overall survival (OS) and safety. Results: In total, 1938 patients were enrolled from 321 institutions in Japan between May 2012 and April 2016 (median follow-up period: 4.9 years). Eligible patients were divided into four groups: A, patients who selected surgery alone (n¼641); B, patients who selected UFT/LV treatment (n¼1239); C, patients who were assigned to surgery alone after randomization (n¼18); D, patients who were assigned to UFT/LV treatment after randomization (n¼17). Based on propensity score-matching, the 3-year DFS rates were 74.0% in group A (402 cases) and 80.9% in group B (804 cases) {hazard ratio [HR] 0.64 [95% confidence interval (CI) 0.50e0.83, P-0.0006]}. The 3-year OS rates were 94.7% in group A and 96.0% in group B [HR 0.79 (95% CI 0.51e1.22, P¼0.2850)]. The median times to relapse were 8.9 months in group A and 16.2 months in group B. The incidence rates of adverse events of grade 3 in group B were 3.9% for diarrhea and 3.1% for liver dysfunction. However, the incidence was extremely low, and none were serious. Conclusions: Adjuvant chemotherapy with UFT/LV significantly improves DFS. Oral UFT/LV as adjuvant chemotherapy shows efficacy with an acceptable safety profile for stage II colon cancer with risk factors. Legal entity responsible for the study: The authors.