UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009047 |
|---|---|
| Receipt number | R000010622 |
| Scientific Title | Study of a real-time monitoring system for intrafraction patient motion in stereotactic body radiation therapy (Lung and Liver cancers) |
| Date of disclosure of the study information | 2012/10/05 |
| Last modified on | 2014/02/25 17:57:34 |
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Basic information
Public title
Study of a real-time monitoring system for intrafraction patient motion in stereotactic body radiation therapy (Lung and Liver cancers)
Acronym
Study of the effectiveness for the real-time intrafraction patient motion monitoring system in stereotactic body radiation therapy
Scientific Title
Study of a real-time monitoring system for intrafraction patient motion in stereotactic body radiation therapy (Lung and Liver cancers)
Scientific Title:Acronym
Study of the effectiveness for the real-time intrafraction patient motion monitoring system in stereotactic body radiation therapy
Region
| Japan |
Condition
Condition
Lung and Liver cancers
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Assessment of a real-time patient intrafraction motion monitoring system
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Deviation of the landmarks in X-ray radiographs from the beginning to the end of the treatment
Key secondary outcomes
Measurement value of the real-time monitoring system for patient intrafraction motion
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
The real-time intrafraction patient motion monitoring system
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
ECOG PS is equal and less than 2
some small tumors in the lungs or liver
treated with stereotactic body radiotherapy
Key exclusion criteria
None
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichi Kashihara |
Organization
Tokyo Radiation Oncology Clinic
Division name
radiology
Zip code
Address
3-5-7 Ariake Koto Ward, Tokyo
TEL
03-3529-5420
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukihiro Uchida |
Organization
Tokyo Radiation Oncology Clinic
Division name
radiology
Zip code
Address
3-5-7 Ariake Koto Ward, Tokyo
TEL
03-3529-5420
Homepage URL
http://www.troc.jp/
uchida.troc@gmail.com
Sponsor or person
Institute
Tokyo Radiation Oncology Clinic
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
None
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
東京放射線クリニック(東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 05 | Day |
Related information
URL releasing protocol
http://www.troc.jp/
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
Completed
Date of protocol fixation
| 2012 | Year | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2013 | Year | 09 | Month | 13 | Day |
Date of closure to data entry
| 2013 | Year | 09 | Month | 13 | Day |
Date trial data considered complete
| 2013 | Year | 09 | Month | 13 | Day |
Date analysis concluded
| 2013 | Year | 10 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 05 | Day |
Last modified on
| 2014 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010622
