Iodine I 131 Ethiodized Oil in Preventing Recurrent Cancer in Patients Who Have Undergone Treatment for Liver Cancer

Phase 3

Completed

• Conditions: Liver Cancer
• Interventions: Radiation: iodine I 131 ethiodized oil; Drug: ethiodized oil

• Registration Number: NCT00870558
• Lead Sponsor: Hospices Civils de Lyon

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.

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.

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2009-03-26
• Study First Submitted QC: 2009-03-26
• Study First Posted: 2009-03-27
• Status Verified: 2009-04
• Primary Completion: 2011-05
• Last Update Submitted: 2011-08-13
• Last Update Posted: 2011-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm I	iodine I 131 ethiodized oil	Patients receive an intra-arterial infusion of iodine I 131 ethiodized oil.
Arm II	ethiodized oil	Patients receive an intra-arterial infusion of unlabeled ethiodized oil.

Primary Outcome Measures

Name	Time	Method
Tumor recurrence at 2 years

Trial Locations

Locations (1)

Hopital Edouard Herriot - Lyon; 🇫🇷 Lyon, France