UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017134 |
|---|---|
| Receipt number | R000019863 |
| Scientific Title | Clinical verification of respiratory synchronized irradiation system with high-speed scanning of heavy-ion beam in treatment for mobile target |
| Date of disclosure of the study information | 2015/05/01 |
| Last modified on | 2016/11/01 14:11:33 |
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Basic information
Public title
Clinical verification of respiratory synchronized irradiation system with high-speed scanning of heavy-ion beam in treatment for mobile target
Acronym
Verification of respiratory synchronized scanning irradiation system of heavy-ion beam
Scientific Title
Clinical verification of respiratory synchronized irradiation system with high-speed scanning of heavy-ion beam in treatment for mobile target
Scientific Title:Acronym
Verification of respiratory synchronized scanning irradiation system of heavy-ion beam
Region
| Japan |
Condition
Condition
Malignant tumor located in thorax or abdomen
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify safety and stability of the heavy-ion scanning system in the treatment of tumor with respiratory movement
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Acute toxicity
Key secondary outcomes
Initial response of local tumor
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
Irradiation fo heavy ion beam
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
suitable for heavy-ion therapy, and necessary to apply respiratory synchronized irradiation
Key exclusion criteria
history of previous radiation therapy at the same site
life expectancy <6 months
Performance status >1
Uncontrolled infection at the same site
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsuji Hiroshi |
Organization
National Institute of Radiological Sciences
Division name
Research center for charged particle therapy
Zip code
Address
4-9-1 Anagawa Inage-ku Chiba Japan
TEL
043-206-3350
h_tsuji@nirs.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuji Hiroshi |
Organization
National Institute of Radiological Sciences
Division name
Research center for charged particle therapy
Zip code
Address
4-9-1 Anagawa Inage-ku Chiba Japan
TEL
043-206-3350
Homepage URL
h_tsuji@nirs.go.jp
Sponsor or person
Institute
National Institute of Radiological Sciences
Institute
Department
Personal name
Funding Source
Organization
National Institute of Radiological Sciences
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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
放射線医学総合研究所（千葉県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 01 | 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
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 22 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 14 | Day |
Last modified on
| 2016 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019863
