Proton Beam Therapy for Unresectable Liver Metastasis | NCT04456621

Studies
Proton Beam Therapy for Unresectable Liver Metastasis

NCT04456621

Sponsor

Samsung Medical Center

Status

Completed

Last Update Posted

Nov 22, 2023Actual

Enrollment

66Actual

Phase

Not Applicable

Conditions

Local Control Rate
Side Effect

Interventions

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Jun 30, 2021Actual

Completion Date

Jul 31, 2021Actual

First Submitted Date

Jun 30, 2020

First Submission Date that Met QC Criteria

Jun 30, 2020

First Posted Date

Jul 2, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 20, 2023

Last Update Posted Date

Nov 22, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

66Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PBT arm	Experimental		Radiation: PBT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PBT	Radiation	Proton beam radiotherapy 70 gray relative biological equivalent (GyRBE)/10 fractions (Fx) or 60 GyRBE/5 Fx	PBT arm

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center		Seoul		135-710	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided