Proton Beam Therapy for Unresectable Liver Metastasis

Proton Beam Radiotherapy for Unresectable Liver Metastasis: Prospective Phase II Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04456621

Enrollment

Registered

2020-07-02

Start date

2019-01-01

Completion date

2021-07-31

Last updated

2023-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Local Control Rate, Side Effect

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.

Interventions

RADIATIONPBT

Proton beam radiotherapy 70 gray relative biological equivalent (GyRBE)/10 fractions (Fx) or 60 GyRBE/5 Fx

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Proton beam radiotherapy : 5 fractions of 12 GyRBE or 10 fractions of 7 GyRBE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026