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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00870558

Enrollment

120

Registered

2009-03-27

Start date

2005-06-30

Completion date

Unknown

Last updated

2011-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cancer

Keywords

adult primary hepatocellular carcinoma, advanced adult primary liver cancer, localized resectable adult primary liver cancer, localized unresectable adult primary liver cancer

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.

Interventions

DRUGethiodized oil

Given as an intra-arterial infusion

RADIATIONiodine I 131 ethiodized oil

Given as an intra-arterial infusion

Study design

Allocation

RANDOMIZED

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Tumor recurrence at 2 years	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026