NCT00027768UnknownPhase 3
Randomised Trial of Adjuvant Hepatic Intra-Arterial Iodine-131-Lipiodol Following Curative Resection of Hepatocellular Carcinoma
National Medical Research Council (NMRC), Singapore6 sites in 1 country300 target enrollmentStarted: June 1, 2001Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 300
- Locations
- 6
- Primary Endpoint
- Recurrence-free survival
Study Overview
Brief Summary
RATIONALE: Radioactive iodine may be effective in reducing the rate of recurrence of liver cancer after surgery to remove the tumor. It is not yet known if radioactive iodine is more effective than no further treatment after surgery.
PURPOSE: Randomized phase III trial to determine the effectiveness of radioactive iodine in treating patients who have undergone surgery for liver cancer.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 17 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •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
- •Bilirubin less than 2.92 mg/dL
- •PT less than 4 seconds over control
- •Creatinine less than 2.26 mg/dL
- •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
- •See Disease Characteristics
- •Recovered from prior surgery
- •No other prior treatment for HCC
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Recurrence-free survival
Secondary Outcomes
- Overall survival
Investigators
Study Sites (6)
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