Proton Beam Therapy for Unresectable Liver Metastasis

NCT04456621 | Completed DMC

• 1 other identifier: 2018-10-048
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Local Control Rate; Side Effect

Outcome Measures

Primary Outcomes (1)

• 6 month local control rate

  local control rate (except local progression)

  at the point of 6 month follow-up after proton beam therapy

Secondary Outcomes (2)

• Overall survival rate

  at the point of 2 year follow-up after proton beam therapy

• 6 month side effect

  at the point of 6 month follow-up after proton beam therapy

Study Arms (1)

PBT arm

EXPERIMENTAL

Radiation: PBT

Interventions

PBT RADIATION

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

PBT arm

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 2, 2020
• Study Start: January 1, 2019
• Primary Completion: June 30, 2021
• Study Completion: July 31, 2021
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)