Adjuvant Treatment by Intra-arterial Injection of Lipiodol-labeled Iodine-131 in Preventing Recurrence of Hepatocellular Carcinoma After Curative Treatment
18 Years
N/A
Both
Liver Cancer
Trial Information
Adjuvant Treatment by Intra-arterial Injection of Lipiodol-labeled Iodine-131 in Preventing Recurrence of Hepatocellular Carcinoma After Curative Treatment
OBJECTIVES:
Primary
- Determine whether treatment with adjuvant intra-arterial iodine I 131 ethiodized oil
reduces the percentage of tumor recurrence in patients with curatively treated
hepatocellular carcinoma.
Secondary
- Evaluate the overall and recurrence-free survival of these patients.
- Evaluate the deterioration of liver function in these patients.
- Evaluate the toxicity of intra-arterial iodine I 131 ethiodized oil in these patients.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive an intra-arterial infusion of iodine I 131 ethiodized oil.
- Arm II: Patients receive an intra-arterial infusion of unlabeled ethiodized oil.
After completion of study treatment, patients are followed periodically for 5 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of hepatocellular carcinoma (HCC)
- Alpha-fetoprotein < 20 ng/mL
- Must have undergone curative treatment for HCC within the past 8-20 weeks, including
1 of the following:
- Curative resection
- Alcohol ablation, radiofrequency ablation, or cryotherapy (for 1 or 2 nodules <
5 cm in diameter)
- No ascites
- No other intrahepatic involvement or nodule progression as assessed by ultrasound
- No extrahepatic metastases
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- ANC ≥ 1,500/mm³
- Platelet count ≥ 50,000/mm³
- Bilirubin ≤ 51 μmol/L
- Creatinine ≤ 120 μmol/L
- Not pregnant or nursing
- Negative pregnancy test
- Child-Pugh score < 8 (class B)
- No decompensated cirrhosis
- No encephalopathy
- No uncontrolled bleeding
- No portal thrombosis, right- or left-branch thrombosis, extrahepatic thrombosis, or
portal reflux by doppler or CT scan
- No unstable medical or surgical disease
- No contraindication to vascular arteriography
- No history of complications after injection of iodine contrast agents
- Not incarcerated
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from all prior therapy
- No prior hormonal treatment, including tamoxifen and somatostatin analogs
- No prior systemic chemotherapy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Tumor recurrence at 2 years
Safety Issue:
No
Principal Investigator
Jerome Dumortier, MD
Investigator Affiliation:
Hopital Edouard Herriot - Lyon
Authority:
United States: Federal Government
Study ID:
CDR0000626727
NCT ID:
NCT00870558
Start Date:
June 2005
Completion Date:
Related Keywords:
- Liver Cancer
- adult primary hepatocellular carcinoma
- advanced adult primary liver cancer
- localized resectable adult primary liver cancer
- localized unresectable adult primary liver cancer
- Liver Neoplasms
- Carcinoma, Hepatocellular
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