Proton Beam Therapy for Unresectable Liver Metastasis

Not Applicable

Completed

• Conditions: Local Control Rate; Side Effect
• Interventions: Radiation: PBT

• Registration Number: NCT04456621
• Lead Sponsor: Samsung Medical Center

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 control and safety.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2020-06-30
• Study First Submitted QC: 2020-06-30
• Study First Posted: 2020-07-02
• Primary Completion: 2021-06-30
• Study Completion: 2021-07-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PBT arm	PBT	-

Primary Outcome Measures

Name	Time	Method
6 month local control rate	at the point of 6 month follow-up after proton beam therapy	local control rate (except local progression)

Secondary Outcome Measures

Name	Time	Method
6 month side effect	at the point of 6 month follow-up after proton beam therapy	side effect
Overall survival rate	at the point of 2 year follow-up after proton beam therapy	overall survival rate

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of