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

Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00870558
• Other study ID #: CDR0000626727
• Secondary ID: HCL-2004-348-3IN
• Status: Completed
• Phase: Phase 3
• First received: March 26, 2009
• Last updated: August 13, 2011
• Start date: June 2005

Study information

• Verified date: April 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Cancer
• Liver Neoplasms

Intervention

Drug:
• ethiodized oil
Given as an intra-arterial infusion

Radiation:
• iodine I 131 ethiodized oil
Given as an intra-arterial infusion

Locations

Country	Name	City	State
France	Hopital Edouard Herriot - Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor recurrence at 2 years			No