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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00238160
First received: October 12, 2005
Last updated: May 29, 2013
Last verified: July 2006
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: 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 NLM:


Further study details as provided by National Cancer Institute (NCI):

Enrollment: 0
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00238160

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

No publications provided

ClinicalTrials.gov Identifier: NCT00238160     History of Changes
Other Study ID Numbers: KYUH-UHA-HCC02-01, CDR0000363800
Study First Received: October 12, 2005
Last Updated: May 29, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Liver Neoplasms
Carcinoma, Hepatocellular
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014