[Randomized-controlled study of treatment with UFT-MMC or UFT-ACR in advanced gastric cancer. Tohoku Study Group of Cancer Treatment for the Digestive Organs].

The effect of UFT-MMC- or UFT-ACR-therapy on the unresectable or recurrent gastric cancer was studied by a multicenter, randomized-controlled trial. All the patients who were randomly divided into the two groups were administered orally with 400 or 600 mg/day of UFT everyday. In addition, the UFT-MMC group was intravenously injected weekly for three weeks and then triweekly after six weeks with 6 or 8 mg/body of MMC, while the UFT-ACR group was intravenously injected with 20 mg/body of ACR for 5 serial-days every three weeks. Out of 88 cases registered, 75 (85.2%) were evaluable, consisting of 40 (31 complete cases) in UFT-MMC and 35 (27 complete cases) in UFT-ACR. There was no difference in various background factors between the two groups. PR, NC and PD was 10/31, 15/31 and 6/31 in the UFT-MMC group, whereas 0/27, 22/27 and 5/27 in the UFT-ACR group, respectively. The efficacy in the former group was higher, though not significant (U-test, p = 0.052), than that in the latter group. However, there was no difference in the 50% survival time (4.9 months in UFT-MMC vs. 5.4 months in UFT-ACR) of the either group.

RCT Entities:   Population Interventions Outcomes