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

Kyoto University

Status and phase: Withdrawn; Phase 3

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

Treatments: Procedure: conventional surgery; Drug: cisplatin; Drug: fluorouracil; Procedure: hepatic arterial infusion; Procedure: chemotherapy; Procedure: surgery; Procedure: adjuvant therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00238160

KYUH-UHA-HCC02-01

CDR0000363800 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed hepatocellular carcinoma (HCC) with portal vein tumor thrombus
• Tumor thrombus in the main trunk or first branch of the portal vein
• No apparent distant metastases on chest CT scan and bone scintigraphy within the past 6 weeks
• No pleural effusion or ascites

PATIENT CHARACTERISTICS:

Age

• Not specified

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Neutrophil count > 1,000/mm^3
• Platelet count > 50,000/mm^3
• Hemoglobin > 8 g/dL

Hepatic

• Bilirubin < 2 times upper limit of normal (ULN)
• ALT and AST < 4 times ULN

Renal

• Creatinine normal

Cardiovascular

• No severe heart disease
• No cardiac effusion

Other

• No other malignant disease
• No high risk for esophageal varices rupture
• No allergy to fluorouracil or cisplatin

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior hepatic arterial chemotherapy
• No prior systemic chemotherapy for HCC

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified