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

Primary Purpose

Liver Cancer

Status
Unknown status
Phase
Phase 3
Locations
Singapore
Study Type
Interventional
Intervention
adjuvant therapy
iodine I 131 ethiodized oil
Sponsored by
National Medical Research Council (NMRC), Singapore
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cancer focused on measuring localized resectable adult primary liver cancer, adult primary hepatocellular carcinoma

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Cancer Centre - Singapore
  • Tan Tock Seng Hospital
  • Changi General Hospital

Outcomes

Primary Outcome Measures

Recurrence-free survival

Secondary Outcome Measures

Overall survival

Full Information

First Posted
December 7, 2001
Last Updated
September 19, 2013
Sponsor
National Medical Research Council (NMRC), Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT00027768
Brief Title
Radioactive Iodine in Treating Patients Who Have Undergone Surgery for Liver Cancer
Official Title
Randomised Trial of Adjuvant Hepatic Intra-Arterial Iodine-131-Lipiodol Following Curative Resection of Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2007
Overall Recruitment Status
Unknown status
Study Start Date
June 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Medical Research Council (NMRC), Singapore

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
localized resectable adult primary liver cancer, adult primary hepatocellular carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Radiation
Intervention Name(s)
iodine I 131 ethiodized oil
Primary Outcome Measure Information:
Title
Recurrence-free survival
Secondary Outcome Measure Information:
Title
Overall survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
London L. Ooi Peng Jin, MD
Organizational Affiliation
National Cancer Centre, Singapore
Official's Role
Study Chair
Facility Information:
Facility Name
National Cancer Centre - Singapore
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Tan Tock Seng Hospital
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Changi General Hospital
City
Singapore
ZIP/Postal Code
529889
Country
Singapore

12. IPD Sharing Statement

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

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