Surgery With or Without Hepatic Arterial Chemotherapy in Treating Patients With Liver Cancer

Phase 3

Withdrawn

• Conditions: Localized Resectable Adult Primary Liver Cancer; Stage III Childhood Liver Cancer

• Registration Number: NCT00238160
• Lead Sponsor: Kyoto University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2005-10-12
• Study First Submitted QC: 2005-10-12
• Study First Posted: 2005-10-13
• Status Verified: 2006-07
• Last Update Submitted: 2013-05-29
• Last Update Posted: 2013-05-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (4)

Kyoto-Katsura Hospital; 🇯🇵 Kyoto, Japan

Kyoto Prefectural University of Medicine; 🇯🇵 Kyoto, Japan

Kyoto City Hospital; 🇯🇵 Kyoto, Japan

Kyoto University Hospital; 🇯🇵 Kyoto, Japan