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:
Hallym University Medical Center
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
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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:
|
|
Active Comparator: Complete embolization
TACE with complete embolization using gelfoam
|
Procedure: Complete embolization
TACE with complete embolization using gelfoam
Other Names:
|
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 May 19, 2013