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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00027768
First received: December 7, 2001
Last updated: February 6, 2009
Last verified: June 2007
History of Changes
  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:

MedlinePlus related topics: Cancer Liver Cancer
U.S. FDA Resources

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

Primary Outcome Measures:
  • Recurrence-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]

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

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00027768

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

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00027768     History of Changes
Other Study ID Numbers: CDR0000069066, NMRC-AHCC03, EU-20128
Study First Received: December 7, 2001
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on June 17, 2013