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

NCT ID: NCT00027768

Last Updated: 2013-09-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-06-30

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.

Conditions

Liver Cancer

Keywords

localized resectable adult primary liver cancer; adult primary hepatocellular carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

adjuvant therapy

Intervention Type: PROCEDURE

iodine I 131 ethiodized oil

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Medical Research Council (NMRC), Singapore

OTHER_GOV

Sponsor Role: lead

Principal Investigators

London L. Ooi Peng Jin, MD

Role: STUDY_CHAIR

National Cancer Centre, Singapore

Locations

National Cancer Centre - Singapore

Singapore, , Singapore

Tan Tock Seng Hospital

Singapore, , Singapore

Changi General Hospital

Singapore, , Singapore

Countries

Singapore

Other Identifiers

NMRC-AHCC03

Identifier Type: -

Identifier Source: secondary_id

EU-20128

Identifier Type: -

Identifier Source: secondary_id

CDR0000069066

Identifier Type: -

Identifier Source: org_study_id