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Clinical Trials/NCT00870558
NCT00870558CompletedPhase 3

Adjuvant Treatment by Intra-arterial Injection of Lipiodol-labeled Iodine-131 in Preventing Recurrence of Hepatocellular Carcinoma After Curative Treatment

Hospices Civils de Lyon1 site in 1 country120 target enrollmentStarted: June 2005Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
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

Experimental

Patients receive an intra-arterial infusion of iodine I 131 ethiodized oil.

Intervention: iodine I 131 ethiodized oil (Radiation)

Arm II

Placebo Comparator

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

Investigators

Sponsor Class
Other

Study Sites (1)

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