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

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00238160
• Other study ID #: KYUH-UHA-HCC02-01
• Secondary ID: CDR0000363800
• Status: Withdrawn
• Phase: Phase 3
• First received: October 12, 2005
• Last updated: May 29, 2013

Study information

• Verified date: July 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Neoplasms
• Localized Resectable Adult Primary Liver Cancer
• Stage III Childhood Liver Cancer

Intervention

Drug:
• cisplatin

• fluorouracil

Procedure:
• adjuvant therapy

• chemotherapy

• conventional surgery

• hepatic arterial infusion

• surgery

Locations

Country	Name	City	State
Japan	Kyoto City Hospital	Kyoto
Japan	Kyoto Prefectural University of Medicine	Kyoto
Japan	Kyoto University Hospital	Kyoto
Japan	Kyoto-Katsura Hospital	Kyoto

Sponsors (1)

Lead Sponsor	Collaborator
Kyoto University

Country where clinical trial is conducted

Japan,