Proton Beam Therapy for Unresectable Liver Metastasis

Side Effect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04456621
• Other study ID #: 2018-10-048
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: July 31, 2021

Study information

• Verified date: November 2023
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: July 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Local Control Rate
• Neoplasm Metastasis
• Side Effect

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 month local control rate	local control rate (except local progression)	at the point of 6 month follow-up after proton beam therapy
Secondary	Overall survival rate	overall survival rate	at the point of 2 year follow-up after proton beam therapy
Secondary	6 month side effect	side effect	at the point of 6 month follow-up after proton beam therapy