Colorectal Cancer Clinical Trial
Official title:
Phase II Study of Radiofrequency Ablation of Colorectal Cancer Liver Metastases Combined With Post-Ablation Hepatic Arterial Infusion of Floxuridine Alternating With 5-Fluorouracil
RATIONALE: Radiofrequency ablation may be able to shrink or destroy cancer cells. Drugs used
in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or
die. Chemotherapy delivered directly into the blood vessels of the liver may prevent new
tumors from growing. Combining these therapies may be an effective treatment for colorectal
cancer that has spread to the liver.
PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation followed by
chemotherapy delivered directly into the blood vessels of the liver in treating patients who
have colorectal cancer that has spread to the liver.
OBJECTIVES: I. Determine the safety and efficacy of radiofrequency tissue ablation followed
by hepatic arterial chemotherapy with floxuridine and fluorouracil in patients with
colorectal cancer metastatic to the liver.
OUTLINE: Patients undergo an open laparotomy to identify the target tumor in the liver using
intraoperative ultrasound followed by radiofrequency tissue ablation over 20 minutes to each
tumor and placement of hepatic arterial catheter. Within 35 days postoperatively, patients
receive hepatic arterial chemotherapy consisting of floxuridine on days 1-7 and fluorouracil
over 1 hour on days 15, 22, and 29. Treatment repeats every 5 weeks for 6 courses. Patients
are followed at 1 month, every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.
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