UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026282 |
|---|---|
| Receipt number | R000030186 |
| Scientific Title | Phase I/II study of transarterial marker placement for particle beam therapy for intrahepatic cholangiocarcinoma |
| Date of disclosure of the study information | 2017/02/23 |
| Last modified on | 2017/02/23 19:43:44 |
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Basic information
Public title
Phase I/II study of transarterial marker placement for particle beam therapy for intrahepatic cholangiocarcinoma
Acronym
Phase I/II study of transarterial marker placement for particle beam therapy for intrahepatic cholangiocarcinoma
Scientific Title
Phase I/II study of transarterial marker placement for particle beam therapy for intrahepatic cholangiocarcinoma
Scientific Title:Acronym
Phase I/II study of transarterial marker placement for particle beam therapy for intrahepatic cholangiocarcinoma
Region
| Japan |
Condition
Condition
intrahepatic 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 hepatocellular carcinoma
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
| 1st name | |
| Middle name | |
| Last name | Kazuki Terashima |
Organization
Hyogo Ion Beam Medical Center
Division name
Department of Radiology
Zip code
Address
1-2-1, Kouto, Tatsuno city, Hyogo
TEL
0791580100
k.terashima@kmyr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuki Terashima |
Organization
Hyogo Ion Beam Medical Center
Division name
Department of Radiology
Zip code
Address
1-2-1, Kouto, Tatsuno city, Hyogo
TEL
0791580100
Homepage URL
k.terashima@kmyr.jp
Sponsor or person
Institute
Hyogo Ion Beam Medical Center
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Date of protocol fixation
| 2017 | Year | 01 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 24 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030186
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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