Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
66 participants
INTERVENTIONAL
2019-01-01
2021-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PBT arm
PBT
Proton beam radiotherapy 70 gray relative biological equivalent (GyRBE)/10 fractions (Fx) or 60 GyRBE/5 Fx
Interventions
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PBT
Proton beam radiotherapy 70 gray relative biological equivalent (GyRBE)/10 fractions (Fx) or 60 GyRBE/5 Fx
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
20 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Park Hee Chul
Professor
Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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2018-10-048
Identifier Type: -
Identifier Source: org_study_id