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

This study is currently recruiting participants.
Verified August 2012 by Hallym University Medical Center
Sponsor:
Information provided by (Responsible Party):
Hallym University Medical Center
ClinicalTrials.gov Identifier:
NCT01677468
First received: August 9, 2012
Last updated: August 29, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Hepatocellular Carcinoma
Transarterial Chemoembolization
Procedure: Intermediate embolization
Procedure: Complete embolization

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Phase Study About Feeding Artery Obliteration by Chemoembolization on Survival of Patients With Unresectable Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Hallym University Medical Center:

Primary Outcome Measures:
  • Survival rate of the subjects [ Time Frame: 6 months after TACE ] [ Designated as safety issue: No ]
    Survival rate of the subjects 6 months after TACE

  • Survival rate of the subjects [ Time Frame: 12 months after TACE ] [ Designated as safety issue: Yes ]
    Survival rate of the subjects, 12 months after TACE

  • Survival rate of the subjects [ Time Frame: 18 months after TACE ] [ Designated as safety issue: Yes ]
    Survival rate of the subjects, 18 months after TACE

  • Survival rate of the subjects [ Time Frame: 24 months after TACE ] [ Designated as safety issue: Yes ]
    Survival rate of the subjects, 24 months after TACE


Secondary Outcome Measures:
  • Disease free survival of the subjects [ Time Frame: 6, 12, 18, and 24 months after TACE ] [ Designated as safety issue: No ]
    Disease free survival of the subjects, 24 months after TACE

  • Complication rate of TACE [ Time Frame: 6, 12, 18, and 24 months after TACE ] [ Designated as safety issue: Yes ]
    The incidence of infection, hemorrhage, 24 months after TACE


Estimated Enrollment: 250
Study Start Date: August 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intermediate embolization
TACE with substatsis using gelfoam
Procedure: Intermediate embolization
TACE with substasis using gelfoam
Other Names:
  • Adriamycin
  • Cysplatin
  • Gelfoam
Active Comparator: Complete embolization
TACE with complete embolization using gelfoam
Procedure: Complete embolization
TACE with complete embolization using gelfoam
Other Names:
  • Adriamycin
  • Cysplatin
  • Gelfoam

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01677468

Contacts
Contact: Sang Hoon Park, M.D., Ph.D. 82-2-829-5493 dr.sanghoon.park@gmail.com
Contact: Su Rin Shin, M.D. 82-2-829-5490 dr.goforit@gmail.com

Locations
Korea, Republic of
Hallym Sacred Heart Hospital Recruiting
Anyang, Korea, Republic of, 431070
Contact: Choong Kee Park, M.D., Ph.D.    82-31-380-3708    ckp@hallym.or.kr   
Chuncheon Sacred Heart Hospital Recruiting
Chuncheon, Korea, Republic of, 200060
Contact: Dong Joon Kim, M.D., Ph.D.    82-33-741-1226    djkim@hallym.ac.kr   
Kangnam Sacred Heart Hostpita Recruiting
Seoul, Korea, Republic of, 150950
Contact: Sang Hoon Park, M.D., Ph.D.    82-2-829-5493    dr.sanghoon.park@gmail.com   
Principal Investigator: Sang Hoon Park, M.D., Ph.D         
Sponsors and Collaborators
Hallym University Medical Center
Investigators
Principal Investigator: Sang Hoon Park, M.D., Ph.D. Hallym University Medical Center
  More Information

No publications provided

Responsible Party: Hallym University Medical Center
ClinicalTrials.gov Identifier: NCT01677468     History of Changes
Other Study ID Numbers: 2011-12-122
Study First Received: August 9, 2012
Last Updated: August 29, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Hallym University Medical Center:
Hepatocellular carcinoma
Transarterial chemoembolization

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Doxorubicin
Gelatin Sponge, Absorbable
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents

ClinicalTrials.gov processed this record on April 15, 2014