Colorectal Cancer Clinical Trial
Official title:
A RANDOMISED TRIAL OF INTRAVENOUS VERSUS INTRAHEPATIC ARTERIAL 5-FU AND LEUCOVORIN FOR COLORECTAL LIVER METASTASES
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of intravenous infusion or
intrahepatic infusion of fluorouracil and leucovorin in treating patients with colorectal
cancer metastatic to the liver.
OBJECTIVES: I. Compare the survival and response rates of patients with colorectal liver
metastases treated with intravenous vs. intrahepatic arterial infusion of
fluorouracil/leucovorin. II. Assess the effect of these 2 treatments on symptoms and quality
of life of these patients.
OUTLINE: Randomized study. Patients randomized to Arm II should have a preoperative hepatic
angiography; at laparotomy, an intrahepatic arterial catheter is fused into the
gastroduodenal artery to establish an infusion of both lobes of the liver. Arm I:
Single-Agent Chemotherapy with Drug Modulation. Fluorouracil, 5-FU, NSC-19893; with
Leucovorin calcium, CF, NSC-3590. Intravenous infusion. Arm II: Single-Agent Chemotherapy
with Drug Modulation. 5-FU; with CF. Intrahepatic arterial infusion.
PROJECTED ACCRUAL: 312 patients are expected to be randomized within 3-4 years.
;
Allocation: Randomized, Primary Purpose: Treatment
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