A multicenter randomized phase II trail of Oxaliplatin in the patients with colorectal cancer

Objective To evaluate the efficacy and safety of Oxaliplatin in the patients with colorectal cancer. Methods In a multicenter randomized control study, a total of 144 patients were divided into four groups: Oxaliplatin (Haitong) + 5-FU, CF (group A) 41 cases; 5-FU + CF (group B) 41 cases; Oxaliplatin (Haitong) + 5-FU, CF (group C) 31 cases; Oxaliplatin (positive drug) + 5-FU + CF (group D) 31 cases. Oxaliplatin combination regimen: L-OHP 130 mg/m 2 i.v. infusion 2 h d1; CF 200 mg/m 2 i.v. 2 h d1–d5; 5-FU 300 mg/m 2 i.v. infusion 4 h d1–d5 (after CF). 5-FU + CF combination regimen: CF 200 mg/m 2 i.v. infusion 2 h d1–d5, 5-FU 300 mg/m 2 i.v. infusion 4h d1–d5 (after CF), the schedule was repeated every 3 weeks. The total cycles were 3. Results After three circles treatment, overall response rate of 4 groups was 24.4% (group A), 2.4% (group B), 25.8% (group C) and 19.4% (group D), respectively. The response rate was significantly different between group A and group B ( P < 0.01), but no significant difference was observed between group C and group D ( P > 0.05). Conclusion The Oxaliplatin (Haitong) for injection combination regimen is effective in the treatment of colorectal cancer.