Comparison Study of Transarterial Chemoembolization and Percutaneous Ethanol Injection for Multiple, Small HCCs

This study is currently recruiting participants.

Verified by Seoul National University Hospital, February 2009

First Received: July 26, 2006 Last Updated: February 9, 2009 History of Changes

Sponsored by:	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:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
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

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:	May 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

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

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

Contacts

Contact: H S Lee, professor

82 2 2072 2228

hsleemd@snu.ac.kr

Locations

Korea, Republic of, Chongno-gu
Seoul NUH	Recruiting
Seoul, Chongno-gu, Korea, Republic of, 110-744
Contact: J H Yoon, Professor 82 2 2072 2731 yoonjh@snu.ac.kr
Sub-Investigator: Won Kim, M.D.

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:	Seoul National University Hospital ( Won Kim )
Study ID Numbers:	07-2006-010
Study First Received:	July 26, 2006
Last Updated:	February 9, 2009
ClinicalTrials.gov Identifier:	NCT00357474 History of Changes
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:

HCC, TACE, PEIT

Study placed in the following topic categories:

Anti-Infective Agents
Liver Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Central Nervous System Depressants
Mitomycins
Doxorubicin
Carcinoma
Liver Neoplasms

Anti-Infective Agents, Local
Digestive System Diseases
Ethiodized Oil
Mitomycin
Gastrointestinal Neoplasms
Adenocarcinoma
Hepatocellular Carcinoma
Neoplasms, Glandular and Epithelial
Ethanol

Additional relevant MeSH terms:

Anti-Infective Agents
Liver Diseases
Neoplasms by Histologic Type
Digestive System Neoplasms
Carcinoma, Hepatocellular
Physiological Effects of Drugs
Central Nervous System Depressants
Pharmacologic Actions
Carcinoma
Liver Neoplasms

Anti-Infective Agents, Local
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Adenocarcinoma
Central Nervous System Agents
Neoplasms, Glandular and Epithelial
Ethanol

ClinicalTrials.gov processed this record on September 10, 2009