NCT00027768

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2001

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2001

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

September 20, 2013

Status Verified

June 1, 2007

First QC Date

December 7, 2001

Last Update Submit

September 19, 2013

Conditions

Liver Cancer

Keywords

localized resectable adult primary liver canceradult primary hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

  • Recurrence-free survival

Secondary Outcomes (1)

  • Overall survival

Interventions

adjuvant therapyPROCEDURE
iodine I 131 ethiodized oilRADIATION

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

National Cancer Centre - Singapore

Singapore, 169610, Singapore

Location

Tan Tock Seng Hospital

Singapore, 308433, Singapore

Location

Changi General Hospital

Singapore, 529889, Singapore

Location

MeSH Terms

Conditions

Liver NeoplasmsCarcinoma, Hepatocellular

Interventions

Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • London L. Ooi Peng Jin, MD

    National Cancer Centre, Singapore

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 7, 2001

First Posted

January 27, 2003

Study Start

June 1, 2001

Last Updated

September 20, 2013

Record last verified: 2007-06

Locations

SG(3)