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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00870558
First received: March 26, 2009
Last updated: August 13, 2011
Last verified: April 2009
  Purpose

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.


Condition Intervention Phase
Liver Cancer
Drug: ethiodized oil
Radiation: iodine I 131 ethiodized oil
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Adjuvant Treatment by Intra-arterial Injection of Lipiodol-labeled Iodine-131 in Preventing Recurrence of Hepatocellular Carcinoma After Curative Treatment

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Tumor recurrence at 2 years [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: June 2005
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00870558

Locations
France
Hopital Edouard Herriot - Lyon
Lyon, France, 69437
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Investigator: Jerome Dumortier, MD Hopital Edouard Herriot - Lyon
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00870558     History of Changes
Other Study ID Numbers: CDR0000626727, HCL-2004-348-3, INCA-RECF0436, HCL-LIPIODOL
Study First Received: March 26, 2009
Last Updated: August 13, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adult primary hepatocellular carcinoma
advanced adult primary liver cancer
localized resectable adult primary liver cancer
localized unresectable adult primary liver cancer

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Liver Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Iodine
Ethiodized Oil
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antineoplastic Agents
Contrast Media
Diagnostic Uses of Chemicals

ClinicalTrials.gov processed this record on September 18, 2014