Hepatocellular CarcinomaPhase 3NCT00357474
Comparison Study of Transarterial Chemoembolization and Percutaneous Ethanol Injection for Multiple, Small HCCs
A Phase 3 study testing Transarterial chemoembolization and Percutaneous ethanol injection therapy in people with Hepatocellular Carcinoma, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to choose the preferred treatment modality for multiple, small hepatocellular carcinomas. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Transarterial chemoembolization and Percutaneous ethanol injection therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2005to Feb 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- In case of hepatic vein or portal vein invasion radiologically(CT or MRI)
Trial locations and contacts
1 site in 1 country.
About this 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.
The purpose of this study is to choose the preferred treatment modality for multiple, small hepatocellular carcinomas.
Read the detailed description
To compare the below things between PEIT group and TACE group
- Survival
- 5 year overall survival rate
- Disease free survival rate
- Recurrence a. recurrence rate
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Transarterial chemoembolization, Percutaneous ethanol injection therapy
- Keywords
- HCC, TACE, PEIT
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transarterial chemoembolizationProcedure or surgery
Also called TACE
lipiodol, adriamycin and/or mitomycin
Percutaneous ethanol injection therapyProcedure or surgery
Also called PEIT
99% ethanol 2-4cc per one session, two to three sessions per single procedure for one week
| Study group | Role | What they receive |
|---|---|---|
| chemotherapy | Active comparator | Transarterial chemoembolization (TACE) Receives: Procedure: Transarterial chemoembolization |
| ethanol | Active comparator | Percutaneous ethanol injection therapy (PEIT) Receives: Procedure: Percutaneous ethanol injection therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival rate
Measured: 5 year
Secondary outcomes (1)
Disease free survival rate and recurrence rate
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2006 (estimated)
- Study startOct 2005
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung-Hwan Yoon, Seoul National University Hospital
- Investigators
- J H Yoon, Professor, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00357474
- Sponsor's protocol ID
- 07-2006-010
- Status last verified
- Dec 2013
- First submitted
- 26 Jul 2006
- Last updated
- 4 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled Trial of the Effective Therapy for Multiple, Small Hepatocellular Carcinomas: Comparing Transarterial Chemoembolization With Percutaneous Ethanol Injection Therapy.
- ClinicalTrials.gov ID
- NCT00357474
- Acronym / sponsor ID
- 07-2006-010
- Conditions
- Hepatocellular Carcinoma
- Keywords
- HCC, TACE, PEIT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 27 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to choose the preferred treatment modality for multiple, small hepatocellular carcinomas.
Detailed description
To compare the below things between PEIT group and TACE group
- Survival
- 5 year overall survival rate
- Disease free survival rate
- Recurrence a. recurrence rate
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chemotherapy | Active comparator | Procedure: Transarterial chemoembolizationTransarterial chemoembolization (TACE) |
| ethanol | Active comparator | Procedure: Percutaneous ethanol injection therapyPercutaneous ethanol injection therapy (PEIT) |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (1 listed)
- In case of hepatic vein or portal vein invasion radiologically(CT or MRI)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transarterial chemoembolizationAlso: TACElipiodol, adriamycin and/or mitomycin | Procedure or surgery | chemotherapy |
| Percutaneous ethanol injection therapyAlso: PEIT99% ethanol 2-4cc per one session, two to three sessions per single procedure for one week | Procedure or surgery | ethanol |
Primary outcome
overall survival rate
Time frame: 5 year
1 secondary outcome
Disease free survival rate and recurrence rate
Time frame: 5 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J H Yoon, Professor principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Transarterial chemoembolization and Percutaneous ethanol injection therapy in people with Hepatocellular Carcinoma, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival rate (time frame: 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2013.