PALLIATIVE LOCAL CHEMOTHERAPY FOR NON-RESECTABLE LIVER METASTASES FROM COLORECTAL CARCINOMA, A RANDOMISED PHASE III STUDY
OBJECTIVES: I. Compare the efficacy of 2 schedules of fluorouracil/leucovorin given as a
continuous intra-arterial infusion via an implantable pump vs. a subcutaneous port for
unresectable liver metastases in patients with colorectal cancer. II. Compare the effect of
each treatment on response rate, quality of life, and rate of technical complications in
these patients.
OUTLINE: Randomized study. The following acronyms are used: CF Leucovorin calcium, NSC-3590
5-FU Fluorouracil, NSC-19893 Arm I: Single-Agent Chemotherapy with Drug Modulation. 5-FU;
with CF. Weekly infusion via an implantable pump. Arm II: Single-Agent Chemotherapy with
Drug Modulation. 5-FU; with CF. Weekly infusion via a subcutaneous infusion port. Arm III:
Single-Agent Chemotherapy with Drug Modulation. 5-FU; with CF. Monthly infusion via an
implantable pump. Arm IV: Single-Agent Chemotherapy with Drug Modulation. 5-FU; with CF.
Monthly infusion via a subcutaneous infusion port.
PROJECTED ACCRUAL: A total of 336 patients will be entered in this multicenter study.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Matthias Lorenz, MD
Study Chair
Klinikum der J.W. Goethe Universitaet
United States: Federal Government
CDR0000064871
NCT00002793
January 1991
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