NCT00002692

Intravenous Compared With Intrahepatic Chemotherapy in Treating Patients With Colorectal Cancer Metastatic to the Liver

A RANDOMISED TRIAL OF INTRAVENOUS VERSUS INTRAHEPATIC ARTERIAL 5-FU AND LEUCOVORIN FOR COLORECTAL LIVER METASTASES

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 312 (estimated)
• Sponsor: Medical Research Council · Other Government
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Colorectal Cancer
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	fluorouracil
DRUG	isolated perfusion
DRUG	leucovorin calcium

Timeline

• Start date: 1994-12-01
• First posted: 2004-05-21
• Last updated: 2013-12-19

Locations

1 site across 1 country: United Kingdom