Local Control RateNCT04456621
Proton Beam Therapy for Unresectable Liver Metastasis
A study testing PBT in people with Local Control Rate and Side Effect, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The investigators performed the present study to evaluate the role of proton beam therapy for liver metastasis which is unresectable and unsuitable for radiofrequency ablation (RFA) in terms of local control and safety. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Local Control Rate, Side Effect
- What is being tested?
- PBT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2019to 31 Jul 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pathologically diagnosed cancer patient
- confirmed liver metastasis via computed tomography (CT) or magnetic resonance imaging (MRI) or biopsy
- unresectable or unsuitable for RFA
- solitary liver metastasis or less than 3 metastatic lesions if the distance is less than 3 cm between metastatic lesions
- case discussed by surgeon, radiologist, and radiation oncologist
- Eastern cooperative oncology group performance status 0 to 2
Show all 9Show fewer
- optimal liver and renal function (Child-Pugh score 10 or less)
- informed consent
- agree to be contraceptive for the duration of the study and for the next 6 months
Who cannot join
- uncontrolled ascites or hepatorenal syndrome
- status of pregnancy or breast-feeding
- less than 12 weeks of expected survival
- combined disease known to have high radiation side effects
- serious acute illness that is not treated other than liver disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Proton Beam Radiotherapy for Unresectable Liver Metastasis: Prospective Phase II Trial
The investigators performed the present study to evaluate the role of proton beam therapy for liver metastasis which is unresectable and unsuitable for radiofrequency ablation (RFA) in terms of local control and safety.
- Conditions
- Local Control Rate, Side Effect
- Being tested
- PBT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBTRadiation
Proton beam radiotherapy 70 gray relative biological equivalent (GyRBE)/10 fractions (Fx) or 60 GyRBE/5 Fx
| Study group | Role | What they receive |
|---|---|---|
| PBT arm | Experimental | Not described Receives: Radiation: PBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 month local control rate
local control rate (except local progression)
Measured: at the point of 6 month follow-up after proton beam therapy
Secondary outcomes (2)
Overall survival rate
overall survival rate
Measured: at the point of 2 year follow-up after proton beam therapy
6 month side effect
side effect
Measured: at the point of 6 month follow-up after proton beam therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start1 Jan 2019
- Primary completion30 Jun 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local Control RateStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Proton beam radiotherapy : 5 fractions of 12 GyRBE or 10 fractions of 7 GyRBE
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Park Hee Chul, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456621
- Sponsor's protocol ID
- 2018-10-048
- Status last verified
- Nov 2023
- First submitted
- 30 Jun 2020
- Last updated
- 22 Nov 2023
- 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 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proton Beam Radiotherapy for Unresectable Liver Metastasis: Prospective Phase II Trial
- ClinicalTrials.gov ID
- NCT04456621
- Acronym / sponsor ID
- 2018-10-048
- Conditions
- Local Control Rate, Side Effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 2 Jul 2020 (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.
The investigators performed the present study to evaluate the role of proton beam therapy for liver metastasis which is unresectable and unsuitable for radiofrequency ablation (RFA) in terms of local control and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Proton beam radiotherapy : 5 fractions of 12 GyRBE or 10 fractions of 7 GyRBE
| Arm | Type | Receives |
|---|---|---|
| PBT arm | Experimental | Radiation: PBT |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- pathologically diagnosed cancer patient
- confirmed liver metastasis via computed tomography (CT) or magnetic resonance imaging (MRI) or biopsy
- unresectable or unsuitable for RFA
- solitary liver metastasis or less than 3 metastatic lesions if the distance is less than 3 cm between metastatic lesions
- case discussed by surgeon, radiologist, and radiation oncologist
Key exclusion criteria (5 listed)
- uncontrolled ascites or hepatorenal syndrome
- status of pregnancy or breast-feeding
- less than 12 weeks of expected survival
- combined disease known to have high radiation side effects
- serious acute illness that is not treated other than liver disease
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 |
|---|---|---|
| PBTProton beam radiotherapy 70 gray relative biological equivalent (GyRBE)/10 fractions (Fx) or 60 GyRBE/5 Fx | Radiation | PBT arm |
Primary outcome
6 month local control rate
Time frame: at the point of 6 month follow-up after proton beam therapy
local control rate (except local progression)
2 secondary outcomes
Overall survival rate
Time frame: at the point of 2 year follow-up after proton beam therapy
6 month side effect
Time frame: at the point of 6 month follow-up after proton beam therapy
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 22 Nov 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PBT in people with Local Control Rate and Side Effect, run by Samsung Medical Center 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 5 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 22 Nov 2023. 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?
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?
6 month local control rate (time frame: at the point of 6 month follow-up after proton beam therapy). 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 22 Nov 2023.