Prospective randomized trial of combined oncological therapy for gastric carcinoma.

One hundred forty-two patients with all stages of gastric carcinoma were prospectively stratified into two divisions according to T.N.M. stage following, but irrespective of the type of surgical procedure. Division I (T1-3, N1-2, M0) was randomized into a control group, and a treatment group who received 2000 rad in 8 fractions over 10 days with intravenous 5 Fluorouracil (5 F.U.) at a dose of 500 mg daily x 4 days preirradiation and then 12.5 mg/kg daily for 5 days every 28 days for six courses. Division II (T4 or M1) was randomized into three groups; a control group, a group who received radiotherapy and 5 F.U. in the same schedule as division one and a group who received Thiotepa 45 mg intravenously daily for three days and then every 28 days for 6 months. Four and one-half years after commencement of the trial 86% of the patients had died. There was no difference in survival rate between the treatment and control groups, (p greater than 0.5) in Division I or II. Survival appeared to correlate with the T.N.M. stage of disease and not therapy. Blind assessment of the quality of life showed no difference between the treatment groups and the controls. In the dose schedules used, this form of oncological therapy had no effect on survival or quality of life in patients with gastric carcinoma.

RCT Entities:   Population Interventions Outcomes