Comparison Study of Transarterial Chemoembolization and Percutaneous Ethanol Injection for Multiple, Small HCCs - Full Text View

Sponsor:	Seoul National University Hospital
Information provided by:	Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT00357474

Purpose

The purpose of this study is to choose the preferred treatment modality for multiple, small hepatocellular carcinomas.

Condition	Intervention	Phase
Hepatocellular Carcinoma	Procedure: Transarterial chemoembolization Procedure: Percutaneous ethanol injection therapy	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Multicenter, Randomized, Controlled Trial of the Effective Therapy for Multiple, Small Hepatocellular Carcinomas: Comparing Transarterial Chemoembolization With Percutaneous Ethanol Injection Therapy.

Resource links provided by NLM:

Drug Information available for: Ethanol Chlorotrianisene

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:

overall survival rate [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Disease free survival rate and recurrence rate [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	284
Study Start Date:	October 2005
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: chemotherapy Transarterial chemoembolization (TACE)	Procedure: Transarterial chemoembolization lipiodol, adriamycin and/or mitomycin Other Name: TACE
Active Comparator: ethanol Percutaneous ethanol injection therapy (PEIT)	Procedure: Percutaneous ethanol injection therapy 99% ethanol 2-4cc per one session, two to three sessions per single procedure for one week Other Name: PEIT

Detailed Description:

To compare the below things between PEIT group and TACE group

Survival
1. 5 year overall survival rate
2. Disease free survival rate
Recurrence a. recurrence rate

Eligibility

Ages Eligible for Study:	20 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The evidences of HBV(+) &/or HCV(+) infection or liver cirrhosis
Two to three tumor nodules with Child-Pugh classification A or single to three tumor nodules with Child-Pugh classification B
The maximal, longest diameter of tumor mass measured by CT finding should be less than 2 cm.
1) Only for newly detected HCCs which were not treated before or 2) If treated before, it should be noted that there is no evidence of recurrence within the latest 6 months and, and also it should be remotely recurred more than 2cm apart from primary lesion.
It should be compatible with the typical findings of HCCs radiologically(MD CT or dynamic MRI)

Exclusion Criteria:

In case of hepatic vein or portal vein invasion radiologically(CT or MRI)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00357474

Locations

Korea, Republic of
Seoul NUH
Seoul, Chongno-gu, Korea, Republic of, 110-744

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Principal Investigator:

J H Yoon, Professor

Seoul National University Hospital

More Information

No publications provided

Responsible Party:	Jung-Hwan Yoon, Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT00357474 History of Changes
Other Study ID Numbers:	07-2006-010
Study First Received:	July 26, 2006
Last Updated:	July 20, 2011
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:

HCC, TACE, PEIT

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
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012