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

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ClinicalTrials.gov Identifier: NCT01677468
Recruitment Status : Unknown
Verified August 2012 by Hallym University Medical Center.
Recruitment status was:  Recruiting
First Posted : September 3, 2012
Last Update Posted : September 3, 2012
Sponsor:
Information provided by (Responsible Party):
Hallym University Medical Center

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
Hepatocellular Carcinoma Transarterial Chemoembolization Procedure: Intermediate embolization Procedure: Complete embolization Not Applicable

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  (Clinical Trial)
Estimated 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 : August 2012
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2015

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




Primary Outcome Measures :
  1. Survival rate of the subjects [ Time Frame: 6 months after TACE ]
    Survival rate of the subjects 6 months after TACE

  2. Survival rate of the subjects [ Time Frame: 12 months after TACE ]
    Survival rate of the subjects, 12 months after TACE

  3. Survival rate of the subjects [ Time Frame: 18 months after TACE ]
    Survival rate of the subjects, 18 months after TACE

  4. Survival rate of the subjects [ Time Frame: 24 months after TACE ]
    Survival rate of the subjects, 24 months after TACE


Secondary Outcome Measures :
  1. 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

  2. Complication rate of TACE [ Time Frame: 6, 12, 18, and 24 months after TACE ]
    The incidence of infection, hemorrhage, 24 months after TACE



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hallym University Medical Center
ClinicalTrials.gov Identifier: NCT01677468     History of Changes
Other Study ID Numbers: 2011-12-122
First Posted: September 3, 2012    Key Record Dates
Last Update Posted: September 3, 2012
Last Verified: August 2012

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
Liposomal doxorubicin
Gelatin Sponge, Absorbable
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants