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.

Condition	Treatment or Intervention	Phase
localized resectable adult primary liver cancer adult primary hepatocellular carcinoma	Drug: iodine I 131 lipiodol  Procedure: adjuvant therapy  Procedure: isotope therapy  Procedure: radiation therapy	Phase III

Further Study Details: 

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.

Ages Eligible for Study:  17 Years and above,  Genders Eligible for Study:  Both

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

Singapore
      Changi General Hospital, Singapore,  529889,  Singapore; Recruiting
      National Cancer Centre - Singapore, Singapore,  169610,  Singapore; Recruiting
      Tan Tock Seng Hospital, Singapore,  308433,  Singapore; Recruiting

Study chairs or principal investigators

London Lucien Ooi Peng Jin, MD,  Study Chair,  National Cancer Centre - Singapore   

Study ID Numbers:  CDR0000069066; NMRC-AHCC03; EU-20128; NCT00027768
Record last reviewed:  July 2002
Last Updated:  December 6, 2004
Record first received:  December 7, 2001
ClinicalTrials.gov Identifier:  NCT00027768
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08