The effects of UFT + MMC and UFT + ACNU therapy on advanced gastric cancer were compared by randomized controlled trial in 12 institutions. Unresectable and postoperatively recurrent patients were divided into PS 0-2 and 3-4 groups. After classification according to cancer spread, such as localized type, hepatic metastatic type, ascitic type and distant metastatic type, regimens of (A) UFT 375 mg/m2/day + MMC 5 mg/m2 for 1-2 W or (B) UFT + ACNU 60 mg/m2/W/x2 (with a 4-week interval) were administered for as long as possible. As a result, among a total of 104 cases, responses were recognized in 7 out of 32 cases (21.9%) treated with regimen A and in 5 out of 25 cases (20.0%) treated with regimen B, giving a total of 57 evaluable cases excluding 33 incompletely evaluated cases and 14 ineligible cases. This study therefore demonstrated no significant difference between the two regimens. The median survival of patients treated with regimen A was 120 days, and that of patients treated with regimen B, 155 days. There was no significant difference between the two regimens. As side effects, UGI symptoms were recognized in 35.4% of regimen A patients and in 37.1% of regimen B patients. Bone marrow suppression appeared in 39.6% of regimen A patients and in 54.3% of regimen B patients.