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Proton Beam Therapy for Unresectable Liver Metasatsis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04456621
Recruitment Status : Recruiting
First Posted : July 2, 2020
Last Update Posted : July 9, 2020
Information provided by (Responsible Party):
Park Hee Chul, Samsung Medical Center

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.

Condition or disease Intervention/treatment Phase
Local Control Rate Side Effect Radiation: PBT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Proton beam radiotherapy : 5 fractions of 12 GyRBE or 10 fractions of 7 GyRBE
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Proton Beam Radiotherapy for Unresectable Liver Metastasis: Prospective Phase II Trial
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2021

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

Primary Outcome Measures :
  1. 6 month local control rate [ Time Frame: at the point of 6 month follow-up after PBT ]
    local control rate (except local progression)

Secondary Outcome Measures :
  1. Overall survival rate [ Time Frame: at the point of 2 year follow-up after PBT ]
    overall survival rate

  2. 6 month side effect [ Time Frame: at the point of 6 month follow-up after PBT ]
    side effect

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04456621

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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Hee Chul Park, M.D., Ph.D.    82-2-3410-2612   
Principal Investigator: Hee Chul Park, M.D., Ph.D.         
Sub-Investigator: Jeong Il Yu, M.D., Ph.D.         
Sub-Investigator: Do Hoon Lim, M.D., Ph.D.         
Sub-Investigator: Jae Myoung Noh, M.D., Ph.D.         
Sponsors and Collaborators
Samsung Medical Center
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Responsible Party: Park Hee Chul, Professor, Samsung Medical Center Identifier: NCT04456621    
Other Study ID Numbers: 2018-10-048
First Posted: July 2, 2020    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No