Colorectal Neoplasms Clinical Trial
Official title:
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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