Abstract: Objective: To investigate the efficiency and safety of the Oxaliplatin, Fluorouracil(FU)and Leucovorin regimen (FOLFOX) in previously untreated patients with metastatic or recurrent colorectal cancer. Methods: Previously untreated patients with metastatic or recurrent colorectal cancer received Oxaliplatin at 100mg/m 2 intravenously (IV) in 2 hours and Leucovorin 400mg/m 2 IV in 2 hours and followed by Fluorouracil 400mg/m² bolus on the first day, and then continuous infusion of Fluorouracil 2,600~3,000mg/m² for 46 hours. Results: The response rate of 97 patients was evaluated.The overall response rate was 35.05%. Nine patients (9.28%) had complete response, and 25 patients (25.77%) had partial response. Thirty- two patients (32.99%) had stable disease and 31 (31.96%) patients had progressed disease. The median time to progression (TTP) was 7.7 months and the median overall survival was 20.5 months. The 1 - and 2 - year survival rates were 68%, and 32%, respectively.According to National Cancer Instiute- Common Toxicity Criteria (NCI- CTC), grade 3/4 toxicity were:neutropenia 12.3%, anemia 11.3%, vomiting 4.1% and diarrhea 7.2%. Grade 3 neuropathy was 5.1%.The overall survival rate of patients who had received radical resection was superior to those who had not received surgery or had received palliactive resection (P=0.0658). The levels of CEA, ALP andLDH were not related to the survival rate (P>0.05). Conclusion: The FOLFOX regimen of Oxaliplatin,Fluorouracil plus Leucovorin was an effective regimen with good tolerability for previously untreated metastatic or recurrent colorectal cancer.