Status:
COMPLETED
Proton Beam Therapy for Unresectable Liver Metastasis
Lead Sponsor:
Samsung Medical Center
Conditions:
Local Control Rate
Side Effect
Eligibility:
All Genders
20+ years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2021
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT04456621
Start Date
January 1 2019
End Date
July 31 2021
Last Update
November 22 2023
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea, 135-710