UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I/II study of transarterial marker placement for particle beam therapy for hilar cholangiocarcinoma
Title of the study (Brief title)	Phase I/II study of transarterial marker placement for particle beam therapy for hilar cholangiocarcinoma
Region	Japan

Condition
Condition	hilar cholangiocarcinoma
Classification by specialty	Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of technical feasibility, effectiveness and safety of transarterial marker placement for particle therapy for hilar cholangiocarcinoma
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase I,II

Assessment
Primary outcomes	The distance between the markers and the edge of GTV
Key secondary outcomes	1. The technical success rate of transarterial marker placement 2. The completion rate of particle therapy using marker 3. The safety of transarterial marker placement

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Pre-particle therapy transcatheter marker placement
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Indication for particle therapy Informed consent
Key exclusion criteria	Allergic reaction to contrast agent
Target sample size	20

Research contact person
Name of lead principal investigator	Kazuki Terashima
Organization	Hyogo Ion Beam Medical Center
Division name	Department of Radiology
Address	1-2-1, Kouto, Tatsuno city, Hyogo
TEL	0791580100
Email	k.terashima@kmyr.jp

Public contact
Name of contact person	Kazuki Terashima
Organization	Hyogo Ion Beam Medical Center
Division name	Department of Radiology
Address	1-2-1, Kouto, Tatsuno city, Hyogo
TEL	0791580100
Homepage URL
Email	k.terashima@kmyr.jp

Sponsor
Institute	Hyogo Ion Beam Medical Center
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 23 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2017 Year 01 Month 18 Day
Anticipated trial start date	2017 Year 02 Month 24 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry	2021 Year 03 Month 31 Day
Date trial data considered complete	2021 Year 08 Month 24 Day
Date analysis concluded	2021 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 02 Month 23 Day
Last modified on	2017 Year 02 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030185