Colorectal Cancer Clinical Trial
Official title:
PALLIATIVE LOCAL CHEMOTHERAPY FOR NON-RESECTABLE LIVER METASTASES FROM COLORECTAL CARCINOMA, A RANDOMISED PHASE III STUDY
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 or giving the drugs in different
ways may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy
administered via an implantable pump with a subcutaneous port for unresectable liver
metastases in patients with resected primary colorectal cancer.
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.
;
Allocation: Randomized, Primary Purpose: Treatment
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