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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)
December 7, 2001
January 27, 2003
September 20, 2013
June 2001
Not Provided
Recurrence-free survival
Not Provided
Complete list of historical versions of study NCT00027768 on ClinicalTrials.gov Archive Site
Overall survival
Not Provided
Not Provided
Not Provided
 
Radioactive Iodine in Treating Patients Who Have Undergone Surgery for Liver Cancer
Randomised Trial of Adjuvant Hepatic Intra-Arterial Iodine-131-Lipiodol Following Curative Resection of Hepatocellular Carcinoma

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.

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.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Liver Cancer
  • Procedure: adjuvant therapy
  • Radiation: iodine I 131 ethiodized oil
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
300
Not Provided
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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
Sexes Eligible for Study: All
17 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Singapore
 
 
NCT00027768
CDR0000069066
NMRC-AHCC03
EU-20128
Not Provided
Not Provided
Not Provided
Not Provided
National Medical Research Council (NMRC), Singapore
Not Provided
Study Chair: London L. Ooi Peng Jin, MD National Cancer Centre, Singapore
National Cancer Institute (NCI)
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP