Radioactive Iodine in Treating Patients Who Have Undergone Surgery for Liver Cancer

Randomised Trial of Adjuvant Hepatic Intra-Arterial Iodine-131-Lipiodol Following Curative Resection of Hepatocellular Carcinoma

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00027768

Enrollment

300

Registered

2003-01-27

Start date

2001-06-30

Completion date

Unknown

Last updated

2013-09-20

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

Conditions

Liver Cancer

Keywords

localized resectable adult primary liver cancer, adult primary hepatocellular carcinoma

Brief summary

RATIONALE: Radioactive iodine may be effective in reducing the rate of recurrence of liver cancer after surgery to remove the tumor. It is not yet known if radioactive iodine is more effective than no further treatment after surgery. PURPOSE: Randomized phase III trial to determine the effectiveness of radioactive iodine in treating patients who have undergone surgery for liver cancer.

Detailed description

OBJECTIVES: * Compare the effect of adjuvant hepatic intra-arterial iodine I 131 lipiodol vs observation in terms of rate of recurrence and overall survival of patients with curatively resected hepatocellular carcinoma. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms. * Arm I: Within 4-6 weeks after prior resection, patients receive adjuvant hepatic intra-arterial iodine I 131 lipiodol once. * Arm II: After prior resection, patients undergo observation. Patients are followed monthly for 1 year and then every 3 months thereafter. PROJECTED ACCRUAL: A minimum of 300 patients (150 per treatment arm) will be accrued for this study.

Interventions

PROCEDUREadjuvant therapy

RADIATIONiodine I 131 ethiodized oil

Study design

Allocation

RANDOMIZED

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

17 Years to No maximum

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologically confirmed primary hepatocellular carcinoma (HCC) * Completely resected disease with clear margins * No residual disease by postoperative CT scan * No metastatic disease PATIENT CHARACTERISTICS: Age: * 17 and over Performance status: * Karnofsky 60-100% Life expectancy: * Not specified Hematopoietic: * WBC greater than 1,500/mm\^3 * Platelet count greater than 50,000/mm\^3 Hepatic: * Bilirubin less than 2.92 mg/dL * PT less than 4 seconds over control Renal: * Creatinine less than 2.26 mg/dL Other: * No contraindication to contrast or radioactive iodine * No uncontrolled thyrotoxicosis * No other prior or concurrent malignancy * Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * See Disease Characteristics * Recovered from prior surgery Other * No other prior treatment for HCC

Design outcomes

Primary

Measure	Time frame
Recurrence-free survival	—

Secondary

Measure	Time frame
Overall survival	—

Countries

Singapore

Outcome results

None listed

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