HepatoCellular CarcinomaSTHNCT03326375
Comparison of SBRTand Repeat TACE for HCC
A study testing SBRT in people with HepatoCellular Carcinoma, run by Gangneung Asan Hospital at 1 site in South Korea.
Trial summary
Comparison of Stereotactic Body Radiation Therapy (SBRT) and repeated transarterial chemoembolization (TACE) for Hepatocellular Carcinoma (HCC)as a Local Salvage Treatment after first incomplete TACE Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- HepatoCellular Carcinoma
- What is being tested?
- SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2017to Mar 2021
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >18 years
- Eastern cooperative oncology group(ECOG) score 0 to 2
- Primary HCC
- HCC (single nodule ≤ 7 cm or max 3 nodules ≤ 3 cm)
- Child-Turgottei-Pugh A or B
- Unresectable lesion or medically contraindicated surgery or a case in which surgery was declined.
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- No evidence of radiologically definable major vascular invasion or extrahepatic disease
- Previously incomplete TACE with radiologically defined residual disease after first TACE
- Informed consent
Who cannot join
- Prior TACE to the target lesion
- Contraindication to receiving radiotherapy or TACE
- Decompensated liver cirrhosis
- Extrahepatic mets
- Pregnancy
- Patients with other cancers
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Gangneung Asan Hospital
Wŏnju, Gangwondo, 25440
Baek Gyu Jun, M.D, 82-10-5674-0712, backyou78@hanmail.net
Gan Jin Cheon, M.D Ph.D., 82-33-610-3018, 1000@gnah.co.kr
About this study
Official title: Comparison of Stereotactic Body Radiation Therapy (SBRT)and Repeat Transarterial Chemoembolization (TACE) for Hepatocellular Carcinoma (HCC) as a Local Salvage Treatment After Incomplete TACE : A Prospective Randomized Trial
Comparison of Stereotactic Body Radiation Therapy (SBRT) and repeated transarterial chemoembolization (TACE) for Hepatocellular Carcinoma (HCC)as a Local Salvage Treatment after first incomplete TACE
Read the detailed description
The aim of this study is to evaluate the effect of SBRT after first incomplete TACE.
In HCC patients with incomplete TACE response, repeated TACE did not showed good response. In this case, SBRT could have better results than TACE.
- Conditions
- HepatoCellular Carcinoma
- Being tested
- SBRT
- Keywords
- TACE, SBRT
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRTRadiation
Also called Stereotactic Body Radiation Therapy
Maximum dose : 60Gray (Gy) Fraction : 2 to 5
| Study group | Role | What they receive |
|---|---|---|
| SBRT (Stereotatic body radiotherapy) | Experimental | Treatment of SBRT in HCC patients who have incomplete response after first TACE Receives: Radiation: SBRT |
| TACE (Transarterial chemoembolization) | No intervention | Treatment of repeated TACE in HCC patients who have incomplete response after first TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local tumor control (efficacy fo SBRT)
To evaluate the effect of SBRT. Local tumor control is defined as the disappearance of any intraarterial enhancement in all target lesions.
Local tumor control will be measured on triphasic Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI). Patient will be asked to visit their study doctor for follow-up exams and imaging (CT or MRI) every 3 months.
Measured: 1 year
Secondary outcomes (3)
progression free-survival
survival from SBRT to recurrence
Measured: 2 year
overall survival
survival from SBRT to death
Measured: 2 year
Radiation induced liver disease (RILD)
Liver toxicities were evaluated using Common Terminology Criteria of Adverse Events (CTCAE).
RILD was defined as elevated liver transaminases more than five times the upper normal limit or a worsening of Child-Pugh (CP) score by 2 within 3 months after SBRT.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start1 Mar 2017
- Primary completionMar 2020 (estimated)
- Study completionMar 2021 (estimated)
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangneung Asan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Soonchunhyang University Hospital
- Responsible party
- Sponsor
- Investigators
- Gab Jin Cheon, M.D, Ph. D, Study director, University of Ulsan College of Medicine, Gangneung Asan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03326375
- Sponsor's protocol ID
- GNH_RT-001
- Acronym
- STH
- Status last verified
- Oct 2017
- First submitted
- 24 Apr 2017
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Stereotactic Body Radiation Therapy (SBRT)and Repeat Transarterial Chemoembolization (TACE) for Hepatocellular Carcinoma (HCC) as a Local Salvage Treatment After Incomplete TACE : A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT03326375
- Acronym / sponsor ID
- STH / GNH_RT-001
- Conditions
- HepatoCellular Carcinoma
- Keywords
- TACE, SBRT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Gangneung Asan HospitalUniversity, hospital or other
- Collaborators
- Soonchunhyang University Hospital
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 31 Oct 2017 (actual)
- 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.
Comparison of Stereotactic Body Radiation Therapy (SBRT) and repeated transarterial chemoembolization (TACE) for Hepatocellular Carcinoma (HCC)as a Local Salvage Treatment after first incomplete TACE
Detailed description
The aim of this study is to evaluate the effect of SBRT after first incomplete TACE.
In HCC patients with incomplete TACE response, repeated TACE did not showed good response. In this case, SBRT could have better results than TACE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SBRT (Stereotatic body radiotherapy) | Experimental | Radiation: SBRTTreatment of SBRT in HCC patients who have incomplete response after first TACE |
| TACE (Transarterial chemoembolization) | No intervention | –Treatment of repeated TACE in HCC patients who have incomplete response after first TACE |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age >18 years
- Eastern cooperative oncology group(ECOG) score 0 to 2
- Primary HCC
- HCC (single nodule ≤ 7 cm or max 3 nodules ≤ 3 cm)
- Child-Turgottei-Pugh A or B
Key exclusion criteria (6 listed)
- Prior TACE to the target lesion
- Contraindication to receiving radiotherapy or TACE
- Decompensated liver cirrhosis
- Extrahepatic mets
- Pregnancy
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 |
|---|---|---|
| SBRTAlso: Stereotactic Body Radiation TherapyMaximum dose : 60Gray (Gy) Fraction : 2 to 5 | Radiation | SBRT (Stereotatic body radiotherapy) |
Primary outcome
Local tumor control (efficacy fo SBRT)
Time frame: 1 year
To evaluate the effect of SBRT. Local tumor control is defined as the disappearance of any intraarterial enhancement in all target lesions. Local tumor control will be measured on triphasic Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI). Patient will be asked to visit their study doctor for follow-up exams and imaging (CT or MRI) every 3 months.
3 secondary outcomes
progression free-survival
Time frame: 2 year
overall survival
Time frame: 2 year
Radiation induced liver disease (RILD)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
- Individual participant dataSharing planned: No
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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.
Gab Jin Cheon, M.D, Ph. D study director
University of Ulsan College of Medicine, Gangneung Asan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SBRT in people with HepatoCellular Carcinoma, run by Gangneung Asan 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 9 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 31 Oct 2017. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Baek Gyu Jun, M.D (+82-10-5764-0712, backyou78@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local tumor control (efficacy fo SBRT) (time frame: 1 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 31 Oct 2017; AzTrials last refreshed its copy on 26 Oct 2026.