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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026933
Receipt No. 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

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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
Email 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
Email koto.masashi@qst.go.jp

Sponsor
Institute Hospital of the National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Sciences and Technology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030853

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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