UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026933 |
|---|---|
| Receipt number | R000030853 |
| Scientific Title | Feasibility study of carbon-ion radiotherapy using the rotating gantry |
| Date of disclosure of the study information | 2017/04/13 |
| Last modified on | 2018/10/02 19:27:13 |
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Basic information
Public title
Feasibility study of carbon-ion radiotherapy using the rotating gantry
Acronym
Carbon-ion radiotherapy using the rotating gantry
Scientific Title
Feasibility study of carbon-ion radiotherapy using the rotating gantry
Scientific Title:Acronym
Carbon-ion radiotherapy using the rotating gantry
Region
| Japan |
Condition
Condition
Head and neck cancer
Prostate cancer
Classification by specialty
| Oto-rhino-laryngology | Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of carbon-ion radiotherapy with the rotating gantry.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Acute adverse reaction (within three months from the beginning of the carbon-ion radiotherapy)
Key secondary outcomes
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
Head and neck cancer: Carbon-ion radiotherapy 57.6-70.4 Gy (RBE)/16frs.
Prostate cancer: Carbon-ion radiotherapy 51.6 Gy (RBE)/12frs.
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
1) Head and neck cancer or prostate cancer which is eligible for carbon-ion radiotherapy as a advanced medical technology A.
2) Performance status: 0 or 1.
3) Patients who can understand and agree to this study by themselves.
Key exclusion criteria
1) Prognosis < 6 months
2) History of the severe complication
3) Active double cancers
4) History of the radiotherapy to the same region
5) Severe infection of the treatment area
6) Severe clinical condition
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi Koto |
Organization
National Institutes for Quantum and Radiological Sciences and Technology
Division name
Hospital of the National Institute of Radiological Sciences
Zip code
Address
Anagawa 4-9-1, Inage-ku 263-8555 Chiba, Japan
TEL
043-206-3360
koto.masashi@qst.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masashi Koto |
Organization
National Institutes for Quantum and Radiological Sciences and Technology
Division name
Hospital of the National Institute of Radiological Sciences
Zip code
Address
Anagawa 4-9-1, Inage-ku 263-8555 Chiba, Japan
TEL
043-206-3360
Homepage URL
koto.masashi@qst.go.jp
Sponsor or person
Institute
Hospital of the National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Sciences and Technology
Institute
Department
Personal name
Funding Source
Organization
Hospital of the National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Sciences and Technology
Organization
Division
Category of Funding Organization
Other
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 | 04 | Month | 13 | 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
| 2017 | Year | 04 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 10 | Day |
Last modified on
| 2018 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030853
