Skip to main content
OpenTrials
Completed

NCT Number: NCT04456621

Proton Beam Therapy for Unresectable Liver Metastasis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Local Control Rate Side Effect

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PBT

Radiation

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

Primary outcomes

  1. 6 month local control rate

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

    local control rate (except local progression)

Secondary outcomes

  1. Overall survival rate

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

    overall survival rate

  2. 6 month side effect

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

    side effect

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 2, 2020
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.