Adjuvant Treatment by Intra-arterial Injection of Lipiodol-labeled Iodine-131 in Preventing Recurrence of Hepatocellular Carcinoma After Curative Treatment
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Tumor recurrence at 2 years
Study Overview
Brief Summary
RATIONALE: Iodine I 131 ethiodized oil may help prevent or delay the recurrence of cancer. It is not yet known whether iodine I 131 ethiodized oil is more effective than non-radiolabeled ethiodized oil in preventing recurrent cancer in patients who have undergone treatment for liver cancer.
PURPOSE: This randomized phase III trial is studying iodine I 131 ethiodized oil to see how well it works compared with non-radiolabeled ethiodized oil in preventing recurrent cancer in patients who have undergone treatment for liver cancer.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Arm I
Patients receive an intra-arterial infusion of iodine I 131 ethiodized oil.
Intervention: iodine I 131 ethiodized oil (Radiation)
Arm II
Patients receive an intra-arterial infusion of unlabeled ethiodized oil.
Intervention: ethiodized oil (Drug)
Outcomes
Primary Outcomes
Tumor recurrence at 2 years
Secondary Outcomes
No secondary outcomes reported