Randomised Trial of Adjuvant Hepatic Intra-Arterial Iodine-131-Lipiodol Following Curative Resection of Hepatocellular Carcinoma
17 Years
N/A
Both
Liver Cancer
Trial Information
Randomised Trial of Adjuvant Hepatic Intra-Arterial Iodine-131-Lipiodol Following Curative Resection of Hepatocellular Carcinoma
OBJECTIVES:
- Compare the effect of adjuvant hepatic intra-arterial iodine I 131 lipiodol vs
observation in terms of rate of recurrence and overall survival of patients with
curatively resected hepatocellular carcinoma.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Within 4-6 weeks after prior resection, patients receive adjuvant hepatic
intra-arterial iodine I 131 lipiodol once.
- Arm II: After prior resection, patients undergo observation. Patients are followed
monthly for 1 year and then every 3 months thereafter.
PROJECTED ACCRUAL: A minimum of 300 patients (150 per treatment arm) will be accrued for
this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed primary hepatocellular carcinoma (HCC)
- Completely resected disease with clear margins
- No residual disease by postoperative CT scan
- No metastatic disease
PATIENT CHARACTERISTICS:
Age:
- 17 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- Not specified
Hematopoietic:
- WBC greater than 1,500/mm^3
- Platelet count greater than 50,000/mm^3
Hepatic:
- Bilirubin less than 2.92 mg/dL
- PT less than 4 seconds over control
Renal:
- Creatinine less than 2.26 mg/dL
Other:
- No contraindication to contrast or radioactive iodine
- No uncontrolled thyrotoxicosis
- No other prior or concurrent malignancy
- Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- See Disease Characteristics
- Recovered from prior surgery
Other
- No other prior treatment for HCC
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Recurrence-free survival
Safety Issue:
No
Principal Investigator
London L. Ooi Peng Jin, MD
Investigator Role:
Study Chair
Investigator Affiliation:
National Cancer Centre, Singapore
Authority:
United States: Federal Government
Study ID:
CDR0000069066
NCT ID:
NCT00027768
Start Date:
June 2001
Completion Date:
Related Keywords:
- Liver Cancer
- localized resectable adult primary liver cancer
- adult primary hepatocellular carcinoma
- Liver Neoplasms
- Carcinoma, Hepatocellular
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