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

Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00027768
• Other study ID #: CDR0000069066
• Secondary ID: NMRC-AHCC03EU-20
• Status: Active, not recruiting
• Phase: Phase 3
• First received: December 7, 2001
• Last updated: September 19, 2013
• Start date: June 2001

Study information

• Verified date: June 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Cancer
• Liver Neoplasms

Intervention

Procedure:
• adjuvant therapy

Radiation:
• iodine I 131 ethiodized oil

Locations

Country	Name	City	State
Singapore	Changi General Hospital	Singapore
Singapore	National Cancer Centre - Singapore	Singapore
Singapore	Tan Tock Seng Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National Medical Research Council (NMRC), Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence-free survival			No
Secondary	Overall survival			No