Localized Resectable Adult Primary Liver Cancer Clinical Trial
Official title:
Phase III Randomized Study of Surgical Resection With Versus Without Postoperative Hepatic Arterial Chemotherapy in Patients With Hepatocellular Carcinoma and Portal Vein Tumor Thrombus
RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Giving drugs directly into the arteries around the tumor may kill more tumor
cells. Giving chemotherapy after surgery may kill any remaining tumor cells. It is not yet
known whether surgery and hepatic arterial chemotherapy are more effective than surgery
alone in treating patients with liver cancer that has spread to the portal vein.
PURPOSE: This randomized phase III trial is studying surgery and hepatic arterial
chemotherapy to see how well they work compared to surgery alone in treating patients with
liver cancer that has spread to the portal vein.
OBJECTIVES:
- Compare the efficacy of surgical resection with vs without postoperative hepatic
arterial chemotherapy in patients with hepatocellular carcinoma and portal vein tumor
thrombus.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to grade
of portal invasion and Child-Pugh classification. Patients are randomized to 1 of 2
treatment arms.
- Arm I: Patients undergo macroscopic curative resection. Within 28 days after surgery,
patients without post-surgery complications undergo hepatic arterial infusion
comprising fluorouracil and cisplatin on days 1-5, 8-12, and 15-19. Treatment continues
for 6 months.
- Arm II: Patients undergo macroscopic curative resection.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this
study.
;
Primary Purpose: Treatment
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