A randomized consent design trial of neoadjuvant chemotherapy with tegafur plus uracil (UFT) for gastric cancer--a single institute study.

OBJECTIVE Various forms of neoadjuvant chemotherapy (NAC) have been applied in the treatment of gastric cancer. The present study was designed to assess the survival benefits of NAC with UFT (tegafur plus uracil) for gastric cancer, as a randomized consent trial as described by Zelen. PATIENTS AND METHODS The present study included 295 patients with resectable gastic cancer between 1991 and 1999. After the patients had been pre-randomized into two groups, a control (no-NAC) group (n=120) and a treatment group (n=175), the treatment group patients were then further stratified into two groups, namely those who wished to join the control group and those who wished to receive NAC with UFT (NAC-UFT group). Patient outcome was surveyed in January 2003. RESULTS Randomization did not necessarily result in an appropriate registration of the patients, and ultimately 193 patients were included in the control group and 102 patients received NAC-UFT. The NAC-UFT was well tolerated by the patients and side-effects were not severe. However, the NAC-UFT group included the patients with significantly higher stages of cancers than the control group. The survival benefit of NAC-UFT was seen in stage 2 or 3 patients, and multivariate analysis also revealed that NAC-UFT was a significant prognostic variable, as were pT, pN, M and the level of nodal dissection, but patient age, gentler and histological grade were not significant variables. CONCLUSION NAC-UFT may be beneficial in the improvement of survival rate after gastric cancer surgery and this treatment modality is worthy of further study with a larger patient sample size.