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

Sponsor
Hallym University Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT01677468
Collaborator
(none)
250
Enrollment
3
Locations
2
Arms
35
Duration (Months)
83.3
Patients Per Site
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Procedure: Intermediate embolization
  • Procedure: Complete embolization
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Phase Study About Feeding Artery Obliteration by Chemoembolization on Survival of Patients With Unresectable Hepatocellular Carcinoma
Study Start Date :
Aug 1, 2012
Anticipated Primary Completion Date :
Jul 1, 2015
Anticipated Study Completion Date :
Jul 1, 2015

Arms and Interventions

Arm Intervention/Treatment
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Survival rate of the subjects [6 months after TACE]

      Survival rate of the subjects 6 months after TACE

    2. Survival rate of the subjects [12 months after TACE]

      Survival rate of the subjects, 12 months after TACE

    3. Survival rate of the subjects [18 months after TACE]

      Survival rate of the subjects, 18 months after TACE

    4. Survival rate of the subjects [24 months after TACE]

      Survival rate of the subjects, 24 months after TACE

    Secondary Outcome Measures

    1. Disease free survival of the subjects [6, 12, 18, and 24 months after TACE]

      Disease free survival of the subjects, 24 months after TACE

    2. Complication rate of TACE [6, 12, 18, and 24 months after TACE]

      The incidence of infection, hemorrhage, 24 months after TACE

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Hallym Sacred Heart Hospital Anyang Korea, Republic of 431070
    2 Chuncheon Sacred Heart Hospital Chuncheon Korea, Republic of 200060
    3 Kangnam Sacred Heart Hostpita Seoul Korea, Republic of 150950

    Sponsors and Collaborators

    • Hallym University Medical Center

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hallym University Medical Center
    ClinicalTrials.gov Identifier:
    NCT01677468
    Other Study ID Numbers:
    • 2011-12-122
    First Posted:
    Sep 3, 2012
    Last Update Posted:
    Sep 3, 2012
    Last Verified:
    Aug 1, 2012
    Keywords provided by Hallym University Medical Center
    Hepatocellular carcinoma
    Transarterial chemoembolization
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Hepatocellular
    Doxorubicin
    Liposomal doxorubicin
    Gelatin Sponge, Absorbable

    Study Results

    No Results Posted as of Sep 3, 2012