Comparison Study of Transarterial Chemoembolization and Percutaneous Ethanol Injection for Multiple, Small HCCs
A Multicenter, Randomized, Controlled Trial of the Effective Therapy for Multiple, Small Hepatocellular Carcinomas: Comparing Transarterial Chemoembolization With Percutaneous Ethanol Injection Therapy.
1 other identifier
interventional
22
1 country
1
Brief Summary
The purpose of this study is to choose the preferred treatment modality for multiple, small hepatocellular carcinomas.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 hepatocellular-carcinoma
Started Oct 2005
Typical duration for phase_3 hepatocellular-carcinoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 26, 2006
CompletedFirst Posted
Study publicly available on registry
July 27, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedDecember 4, 2013
December 1, 2013
6.3 years
July 26, 2006
December 2, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall survival rate
5 year
Secondary Outcomes (1)
Disease free survival rate and recurrence rate
5 year
Study Arms (2)
chemotherapy
ACTIVE COMPARATORTransarterial chemoembolization (TACE)
ethanol
ACTIVE COMPARATORPercutaneous ethanol injection therapy (PEIT)
Interventions
lipiodol, adriamycin and/or mitomycin
99% ethanol 2-4cc per one session, two to three sessions per single procedure for one week
Eligibility Criteria
You may qualify if:
- 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.
- \) 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)
You may not qualify if:
- In case of hepatic vein or portal vein invasion radiologically(CT or MRI)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul NUH
Seoul, Chongno-gu, 110-744, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
J H Yoon, Professor
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 26, 2006
First Posted
July 27, 2006
Study Start
October 1, 2005
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
December 4, 2013
Record last verified: 2013-12