Proton Beam Therapy for Unresectable Liver Metastasis

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

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.

Study Overview

• Status: Completed
• Conditions: Side Effect; Local Control Rate
• Intervention / Treatment: Radiation: PBT

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PBT arm	Radiation: PBT; Proton beam radiotherapy 70 gray relative biological equivalent (GyRBE)/10 fractions (Fx) or 60 GyRBE/5 Fx

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): July 31, 2021

Study Registration Dates

• First Submitted: June 30, 2020
• First Submitted That Met QC Criteria: June 30, 2020
• First Posted (Actual): July 2, 2020

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: 2018-10-048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No