Surgery With or Without Hepatic Arterial Chemotherapy in Treating Patients With Liver Cancer - Full Text View

Sponsored by:	Kyoto University
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00238160

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 III

Study Type:	Interventional
Study Design:	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:

MedlinePlus related topics: Cancer Liver Cancer Surgery

Drug Information available for: Fluorouracil Cisplatin

U.S. FDA Resources

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

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

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

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000363800, KYUH-UHA-HCC02-01
Study First Received:	October 12, 2005
Last Updated:	July 6, 2006
ClinicalTrials.gov Identifier:	NCT00238160 History of Changes
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Antimetabolites
Liver Diseases
Digestive System Neoplasms
Immunologic Factors
Carcinoma, Hepatocellular
Adjuvants, Immunologic
Immunosuppressive Agents
Thrombosis

Carcinoma
Liver Neoplasms
Digestive System Diseases
Cisplatin
Fluorouracil
Hepatocellular Carcinoma, Childhood
Gastrointestinal Neoplasms
Hepatocellular Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Liver Diseases
Digestive System Neoplasms
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs

Immunosuppressive Agents
Pharmacologic Actions
Liver Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Fluorouracil
Therapeutic Uses

ClinicalTrials.gov processed this record on September 11, 2009