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

Primary Purpose

Hepatocellular Carcinoma, Transarterial Chemoembolization

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Intermediate embolization
Complete embolization
Sponsored by
Hallym University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular carcinoma, Transarterial chemoembolization

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hallym Sacred Heart HospitalRecruiting
  • Chuncheon Sacred Heart HospitalRecruiting
  • Kangnam Sacred Heart HostpitaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intermediate embolization

Complete embolization

Arm Description

TACE with substatsis using gelfoam

TACE with complete embolization using gelfoam

Outcomes

Primary Outcome Measures

Survival rate of the subjects
Survival rate of the subjects 6 months after TACE
Survival rate of the subjects
Survival rate of the subjects, 12 months after TACE
Survival rate of the subjects
Survival rate of the subjects, 18 months after TACE
Survival rate of the subjects
Survival rate of the subjects, 24 months after TACE

Secondary Outcome Measures

Disease free survival of the subjects
Disease free survival of the subjects, 24 months after TACE
Complication rate of TACE
The incidence of infection, hemorrhage, 24 months after TACE

Full Information

First Posted
August 9, 2012
Last Updated
August 29, 2012
Sponsor
Hallym University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01677468
Brief Title
Survival According to the Feeding Artery Obliteration by Chemoembolization for Unresectable Hepatocellular Carcinoma
Official Title
Phase Study About Feeding Artery Obliteration by Chemoembolization on Survival of Patients With Unresectable Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
July 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hallym University Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Transarterial Chemoembolization
Keywords
Hepatocellular carcinoma, Transarterial chemoembolization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intermediate embolization
Arm Type
Experimental
Arm Description
TACE with substatsis using gelfoam
Arm Title
Complete embolization
Arm Type
Active Comparator
Arm Description
TACE with complete embolization using gelfoam
Intervention Type
Procedure
Intervention Name(s)
Intermediate embolization
Other Intervention Name(s)
Adriamycin, Cysplatin, Gelfoam
Intervention Description
TACE with substasis using gelfoam
Intervention Type
Procedure
Intervention Name(s)
Complete embolization
Other Intervention Name(s)
Adriamycin, Cysplatin, Gelfoam
Intervention Description
TACE with complete embolization using gelfoam
Primary Outcome Measure Information:
Title
Survival rate of the subjects
Description
Survival rate of the subjects 6 months after TACE
Time Frame
6 months after TACE
Title
Survival rate of the subjects
Description
Survival rate of the subjects, 12 months after TACE
Time Frame
12 months after TACE
Title
Survival rate of the subjects
Description
Survival rate of the subjects, 18 months after TACE
Time Frame
18 months after TACE
Title
Survival rate of the subjects
Description
Survival rate of the subjects, 24 months after TACE
Time Frame
24 months after TACE
Secondary Outcome Measure Information:
Title
Disease free survival of the subjects
Description
Disease free survival of the subjects, 24 months after TACE
Time Frame
6, 12, 18, and 24 months after TACE
Title
Complication rate of TACE
Description
The incidence of infection, hemorrhage, 24 months after TACE
Time Frame
6, 12, 18, and 24 months after TACE

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sang Hoon Park, M.D., Ph.D.
Phone
82-2-829-5493
Email
dr.sanghoon.park@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Su Rin Shin, M.D.
Phone
82-2-829-5490
Email
dr.goforit@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Hoon Park, M.D., Ph.D.
Organizational Affiliation
Hallym University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hallym Sacred Heart Hospital
City
Anyang
ZIP/Postal Code
431070
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Choong Kee Park, M.D., Ph.D.
Phone
82-31-380-3708
Email
ckp@hallym.or.kr
Facility Name
Chuncheon Sacred Heart Hospital
City
Chuncheon
ZIP/Postal Code
200060
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong Joon Kim, M.D., Ph.D.
Phone
82-33-741-1226
Email
djkim@hallym.ac.kr
Facility Name
Kangnam Sacred Heart Hostpita
City
Seoul
ZIP/Postal Code
150950
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Hoon Park, M.D., Ph.D.
Phone
82-2-829-5493
Email
dr.sanghoon.park@gmail.com
First Name & Middle Initial & Last Name & Degree
Sang Hoon Park, M.D., Ph.D

12. IPD Sharing Statement

Learn more about this trial

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

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