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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00238160
Recruitment Status : Withdrawn
First Posted : October 13, 2005
Last Update Posted : May 30, 2013
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Localized Resectable Adult Primary Liver Cancer Stage III Childhood Liver Cancer Drug: cisplatin Drug: fluorouracil Procedure: adjuvant therapy Procedure: chemotherapy Procedure: conventional surgery Procedure: hepatic arterial infusion Procedure: surgery Phase 3

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • Not specified

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified


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


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


  • Creatinine normal


  • No severe heart disease
  • No cardiac effusion


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


Biologic therapy

  • Not specified


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

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00238160

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Kyoto Prefectural University of Medicine
Kyoto, Japan, 602-8566
Kyoto City Hospital
Kyoto, Japan, 604-8845
Kyoto University Hospital
Kyoto, Japan, 606-8501
Kyoto-Katsura Hospital
Kyoto, Japan, 615-8256
Sponsors and Collaborators
Kyoto University
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Study Chair: Iwao Ikai, MD Kyoto University

Layout table for additonal information Identifier: NCT00238160     History of Changes
Other Study ID Numbers: KYUH-UHA-HCC02-01
CDR0000363800 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: October 13, 2005    Key Record Dates
Last Update Posted: May 30, 2013
Last Verified: July 2006

Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs