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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00027768
First Posted: January 27, 2003
Last Update Posted: September 20, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  Purpose

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 Intervention Phase
Liver Cancer Procedure: adjuvant therapy Radiation: iodine I 131 ethiodized oil Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Randomised Trial of Adjuvant Hepatic Intra-Arterial Iodine-131-Lipiodol Following Curative Resection of Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Recurrence-free survival

Secondary Outcome Measures:
  • Overall survival

Estimated Enrollment: 300
Study Start Date: June 2001
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00027768


Locations
Singapore
National Cancer Centre - Singapore
Singapore, Singapore, 169610
Tan Tock Seng Hospital
Singapore, Singapore, 308433
Changi General Hospital
Singapore, Singapore, 529889
Sponsors and Collaborators
National Medical Research Council (NMRC), Singapore
Investigators
Study Chair: London L. Ooi Peng Jin, MD National Cancer Centre, Singapore
  More Information

ClinicalTrials.gov Identifier: NCT00027768     History of Changes
Other Study ID Numbers: CDR0000069066
NMRC-AHCC03
EU-20128
First Submitted: December 7, 2001
First Posted: January 27, 2003
Last Update Posted: September 20, 2013
Last Verified: June 2007

Keywords provided by National Cancer Institute (NCI):
localized resectable adult primary liver cancer
adult primary hepatocellular carcinoma

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Liver Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Iodine
Ethiodized Oil
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antineoplastic Agents