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

May 29, 2013 updated by: Kyoto University

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kyoto, Japan, 602-8566
        • Kyoto Prefectural University of Medicine
      • Kyoto, Japan, 606-8501
        • Kyoto University Hospital
      • Kyoto, Japan, 615-8256
        • Kyoto-Katsura Hospital
      • Kyoto, Japan, 604-8845
        • Kyoto City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyoto University

Investigators

  • Study Chair: Iwao Ikai, MD, Kyoto University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

October 12, 2005

First Submitted That Met QC Criteria

October 12, 2005

First Posted (Estimate)

October 13, 2005

Study Record Updates

Last Update Posted (Estimate)

May 30, 2013

Last Update Submitted That Met QC Criteria

May 29, 2013

Last Verified

July 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KYUH-UHA-HCC02-01
  • CDR0000363800 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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