A phase III randomized study comparing doxifluridine and 5-fluorouracil as supportive chemotherapy in advanced and recurrent gastric cancer.

We conducted a phase III randomized study to investigate effects of supportive chemotherapy with oral doxifluridine (group A, 75 patients) or 5-fluorouracil (group B, 75 patients) in advanced gastric cancer when intensive chemotherapy was not an option. Although there were no significant differences between the groups with regard to survival, hospital-free survival and time to progression, median values of 3 endpoints were superior in group A. Secondary analysis showed that group A patients with prior chemotherapy tended to have longer survival and hospital-free survival and significantly longer time to progression.