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

NCT ID: NCT00870558

Last Updated: 2011-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30

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.

Conditions

Liver Cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Study Groups

Arm I

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

Group Type: EXPERIMENTAL

iodine I 131 ethiodized oil

Intervention Type: RADIATION

Given as an intra-arterial infusion

Arm II

Patients receive an intra-arterial infusion of unlabeled ethiodized oil.

Group Type: PLACEBO_COMPARATOR

ethiodized oil

Intervention Type: DRUG

Given as an intra-arterial infusion

Interventions

ethiodized oil

Given as an intra-arterial infusion

Intervention Type: DRUG

iodine I 131 ethiodized oil

Given as an intra-arterial infusion

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Principal Investigators

Jerome Dumortier, MD

Role:

Hopital Edouard Herriot - Lyon

Locations

Hopital Edouard Herriot - Lyon

Lyon, , France

Countries

France

Other Identifiers

HCL-2004-348-3

Identifier Type: -

Identifier Source: secondary_id

INCA-RECF0436

Identifier Type: -

Identifier Source: secondary_id

HCL-LIPIODOL

Identifier Type: -

Identifier Source: secondary_id

CDR0000626727

Identifier Type: -

Identifier Source: org_study_id