Intraoperative Intraportal Chemotherapy Combined With Adjuvant Chemotherapy for Stage II and III Colorectal Cancer

A Prospective,Randomized Control Trial of Intraoperative Intraportal Chemotherapy (5-FU and Oxaliplatin) Combined With Adjuvant Chemotherapy to Prevent Liver Metastasis in Patients Receiving Curative Colorectal Cancer Resection.

In this study, the investigators assessed whether intraoperative Intraportal infusion of 5-FU and oxaliplatin is able to prevent liver metastasis in patients receiving curative colorectal cancer resection.

In this study, the investigators assessed whether intraoperative Intraportal infusion of 5-FU and oxaliplatin is able to prevent liver metastasis and improve survival in patients with Stage II or Stage III colorectal cancer without apparent liver metastasis based on a thorough preoperative evaluation.

Patients with stage II or stage III colorectal cancer (CRC) were randomly assigned to two arms.Arm A: 5-FU 1g and oxaliplatin 100mg + curative resection (study group, n=132). Arm B: curative resection alone (control group, n=132).Follow-up: X-ray, US, CT, blood test, colonoscopy,every 3months.

The study endpoints were disease-free survival, overall survival, and liver metastasis-free survival as evaluated by intent-to-treat analysis.

Inclusion criteria

1. Age ≥ 18 and ≤ 75 years and with histologically proven adenocarcinoma of the colon or rectum
2. WHO performance status of 0 or 1
3. Stage II (T3-4, N0, M0) or Stage III (T0-4, N1-2, M0) disease (according to the 1997 revision of the International Union Against Cancer TNM staging system) as determined by a preoperative evaluation that included colonoscopy and an abdominal computed tomography (CT) scan
4. Written informed consent for participation in the trial.

Exclusion criteria

1. has prior other malignant cancer
2. has severe major organ dysfunction
3. has prior cancer therapy before surgery