in which capecitabine was recognized as a standard postoperative adjuvant naratriptan chemotherapy for colorectal cancer. Although capecitabine was approved in Japan based on the results of this trial, it has not yet been established to be a safe postoperative adjuvant therapy for colon cancer in Japanese patients. Accordingly, a feasibility study with an endpoint of the treatment completion rate of capecitabine in Japanese patients was planned. Patients who met any of the following criteria were excluded from participation in the study. (1) Pregnant or lactating, or planning to become pregnant. (2) History of hypersensitivity or severe adverse reaction to fluoropyrimidines.

Past organ transplant. (4) Serious concurrent disease [including interstitial pneumonia,  Taxifolin pulmonary fibrosis, intestinal paralysis, ileus, poorly controlled diabetes, liver cirrhosis or hepatitis (type B or C), poorly controlled hypertension, history of myocardial infarction or unstable angina within past 6 months]. (5) Active multiple primary cancer (disease-free less than 5 years). (6) Concurrent infectious disease. (7) Judged to be unsuitable for participation in the clinical study by the investigator for any other reason.General findings, peripheral blood counts, blood chemistry values and clinical findings were generally recorded at each visit during treatment. To assess HFS, photos of both the palms and the soles of the feet of patients were taken at baseline, at the onset of each grade of HFS and at recovery, with consent of the patient. Protocol completion was defined as the completion of eight 3-week cycles of 14 days of capecitabine followed by a 7-day rest period according to protocol in patients who were enrolled and started on purchase Acadesine treatment within 8 weeks postoperatively.

If the eighth cycle was suspended, a ninth cycle was planned for patients meeting the treatment resumption criteria. These patients were considered to have completed eight cycles. Completion was judged by a central assessment committee in cases of protocol deviations or violations. The objective of the current study was to find the estimated treatment completion rate in the patient population meeting the enrolment criteria for treatment with capecitabine as postoperative adjuvant therapy for colon cancer. The treatment completion rate was 83% in the X-ACT trial conducted outside of Japan using the same regimen.Although the exact number of completing patients is unknown, the order Acadesine estimated 95% confidence interval (CI) was 80–86%.

The study was estimated to require a sample size of at least 87 patients to ensure that the 95% confidence limit of the estimated treatment completion rate was within 10% of either side of the estimated value (if 70 of the 87 patients completed treatment, the estimated observation rate, or the estimated treatment completion rate, would be 80.5% with a 95% CI of 70.6–88.2%, resulting in a 9.9% difference between the estimated value and the vasculature lower confidence limit). A target enrolment size of 92 was selected, to account for patient attrition of approximately 5% due to ineligibility or other reasons. Capecitabine was therefore approved as a postoperative adjuvant therapy for colon cancer at this dosage in Japan in December 2007 based on the results of the non-Japanese.