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

August 13, 2011 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69437
        • Hopital Edouard Herriot - Lyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I
Patients receive an intra-arterial infusion of iodine I 131 ethiodized oil.
Radiation: iodine I 131 ethiodized oil
Given as an intra-arterial infusion
Placebo Comparator: Arm II
Patients receive an intra-arterial infusion of unlabeled ethiodized oil.
Drug: ethiodized oil
Given as an intra-arterial infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Tumor recurrence at 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Jerome Dumortier, MD, Hopital Edouard Herriot - Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

March 26, 2009

First Submitted That Met QC Criteria

March 26, 2009

First Posted (Estimate)

March 27, 2009

Study Record Updates

Last Update Posted (Estimate)

August 16, 2011

Last Update Submitted That Met QC Criteria

August 13, 2011

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000626727
  • HCL-2004-348-3
  • INCA-RECF0436
  • HCL-LIPIODOL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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