Survival According to the Feeding Artery Obliteration by Chemoembolization for Unresectable Hepatocellular Carcinoma

August 29, 2012 updated by: Hallym University Medical Center

Phase Study About Feeding Artery Obliteration by Chemoembolization on Survival of Patients With Unresectable Hepatocellular Carcinoma

The aim of this study was to evaluate whether survival of patients who underwent TACE with unresectable HCC can benefit from intermediate-levels of embolization.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Subjective angiographic chemoembolization endpoints (SACE) levels were developed to standardize the embolic endpoints of transarterial chemoembolization (TACE) for hepatocellular carcinoma (HCC). It determined the antegrade arterial flow and residual tumor blush as follows: I, normal-normal; II, reduced-reduced; III, reduced-none; IV, none-none. SACE level II and III indicates intermediate-levels of embolization, whereas IV indicates overembolization. The aim of this study was to evaluate whether survival of patients who underwent TACE with unresectable HCC can benefit from intermediate-levels of embolization.

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Anyang, Korea, Republic of, 431070
        • Recruiting
        • Hallym Sacred Heart Hospital
        • Contact:
          • Choong Kee Park, M.D., Ph.D.
          • Phone Number: 82-31-380-3708
          • Email: ckp@hallym.or.kr
      • Chuncheon, Korea, Republic of, 200060
        • Recruiting
        • Chuncheon Sacred Heart Hospital
        • Contact:
      • Seoul, Korea, Republic of, 150950
        • Recruiting
        • Kangnam Sacred Heart Hostpita
        • Contact:
        • Principal Investigator:
          • Sang Hoon Park, M.D., Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age over 18
  • ECOG performance status 0-2
  • Hepatocellular carcinoma diagnosed histologically or clinically
  • Tumor numbers of 5 or less
  • No history of treatment for hepatocellular carcinoma
  • Patients with informed consent

Exclusion Criteria:

  • Extrahepatic metastasis
  • Rupture of hepatocellular carcinoma
  • Infiltrative hepatocellular carcinoma
  • Malignancy other than hepatocellular carcinoma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intermediate embolization
TACE with substatsis using gelfoam
Procedure: Intermediate embolization
TACE with substasis using gelfoam
Other Names:
  • Adriamycin
  • Gelfoam
  • Cysplatin
Active Comparator: Complete embolization
TACE with complete embolization using gelfoam
Procedure: Complete embolization
TACE with complete embolization using gelfoam
Other Names:
  • Adriamycin
  • Gelfoam
  • Cysplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival rate of the subjects
Time Frame: 6 months after TACE
Survival rate of the subjects 6 months after TACE
6 months after TACE
Survival rate of the subjects
Time Frame: 12 months after TACE
Survival rate of the subjects, 12 months after TACE
12 months after TACE
Survival rate of the subjects
Time Frame: 18 months after TACE
Survival rate of the subjects, 18 months after TACE
18 months after TACE
Survival rate of the subjects
Time Frame: 24 months after TACE
Survival rate of the subjects, 24 months after TACE
24 months after TACE

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease free survival of the subjects
Time Frame: 6, 12, 18, and 24 months after TACE
Disease free survival of the subjects, 24 months after TACE
6, 12, 18, and 24 months after TACE
Complication rate of TACE
Time Frame: 6, 12, 18, and 24 months after TACE
The incidence of infection, hemorrhage, 24 months after TACE
6, 12, 18, and 24 months after TACE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hallym University Medical Center

Investigators

  • Principal Investigator: Sang Hoon Park, M.D., Ph.D., Hallym University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Anticipated)

July 1, 2015

Study Completion (Anticipated)

July 1, 2015

Study Registration Dates

First Submitted

August 9, 2012

First Submitted That Met QC Criteria

August 29, 2012

First Posted (Estimate)

September 3, 2012

Study Record Updates

Last Update Posted (Estimate)

September 3, 2012

Last Update Submitted That Met QC Criteria

August 29, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-12-122

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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