Phase III Randomized Study of Surgical Resection With Versus Without Postoperative Hepatic Arterial Chemotherapy in Patients With Hepatocellular Carcinoma and Portal Vein Tumor Thrombus
N/A
N/A
Both
Localized Resectable Adult Primary Liver Cancer, Stage III Childhood Liver Cancer
Trial Information
Phase III Randomized Study of Surgical Resection With Versus Without Postoperative Hepatic Arterial Chemotherapy in Patients With Hepatocellular Carcinoma and Portal Vein Tumor Thrombus
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Iwao Ikai, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Kyoto University
Authority:
United States: Federal Government
Study ID:
KYUH-UHA-HCC02-01
NCT ID:
NCT00238160
Start Date:
Completion Date:
Related Keywords:
- Localized Resectable Adult Primary Liver Cancer
- Stage III Childhood Liver Cancer
- Liver Neoplasms
- Carcinoma, Hepatocellular
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