Adjuvant chemotherapy for stage III colon cancer is internationally accepted as standard treatment with established efficacy, but the usefulness of adjuvant chemotherapy for stage II colon cancer remains controversial.
The major Western guidelines recommend adjuvant chemotherapy for “high-risk stage II” cancer, but this is not clearly defined and the efficacy has not been confirmed.
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Treatment delivery and adverse events are entered into a web-based case report form system every 3 months. The primary endpoint is disease-free survival, and the secondary endpoints are overall survival, recurrence-free survival, and incidence and severity of adverse events.
In an additional translational study, the m RNA expression of 5-FU-related enzymes, microsatellite instability and chromosomal instability, and histopathological factors including tumor budding are assessed to evaluate correlation with recurrences, survivals and adverse events.
Superiority of adjuvant therapy with UFT compared to observation without any adjuvant therapy is evaluated.
UFT is a combination drug of tegafur and uracil at a molar ratio of 1:4 and is characterized by long maintenance of a high 5-FU concentration level converted from tegafur in blood/tumors due to inhibition of degeneration of 5-FU by uracil.
In the randomized controlled trial (RCT) comparing 2-year adjuvant therapy using UFT (400 mg/body) with observation without adjuvant therapy in 289 patients after surgery for stage II/III colon and rectal cancer , the 5-year RFS was significantly better in the UFT group.
SACURA trial is a multicenter randomized phase III study which aims to evaluate the superiority of 1-year adjuvant treatment with UFT to observation without any adjuvant treatment after surgery for stage II colon cancer in a large population, and to identify “high-risk factors of recurrence/death” in stage II colon cancer and predictors of efficacy and adverse events of the chemotherapy.
Patients aged between 20 and 80 years with curatively resected stage II colon cancer are randomly assigned to a observation group or UFT adjuvant therapy group (UFT at 500–600 mg/day as tegafur in 2 divided doses after meals for 5 days, followed by 2-day rest.