Proton Beam Therapy for Unresectable Liver Metastasis

Samsung Medical Center

Status: Completed

Conditions: Local Control Rate; Side Effect

Treatments: Radiation: PBT

Study type: Interventional

Funder types: Other

Identifiers

NCT04456621

2018-10-048

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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66 participants in 1 patient group

PBT arm

Experimental group

Treatment:

Radiation: PBT