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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029201
Receipt No. R000033378
Official scientific title of the study Feasibility study of the respirately gated carbon-ion radiotherapy using the rotating gantry
Date of disclosure of the study information 2017/10/01
Last modified on 2017/09/20

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Basic information
Official scientific title of the study Feasibility study of the respirately gated carbon-ion radiotherapy using the rotating gantry
Title of the study (Brief title) Respirately gated carbon-ion radiotherapy using the rotating gantry
Region
Japan

Condition
Condition malignancy located chest or abdomen
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety of respirately gated carbon-ion radiotherapy using 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 begining 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 Carbon-ion radiotherapy for the tumor located in the chest or abdomen
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)The cancer of chest or abdomen which moves with respiration and 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 Yamamoto Naoyoshi
Organization National Institute of Quantum and Radiological Science and Technology
Division name Hospital of the National Institute of Radilogical Sciences
Address Anagawa 4-9-1, Inage-ku 263-8555 Chiba, Japan
TEL 043-206-3360
Email yamamoto.naoyoshi@qst.go.jp

Public contact
Name of contact person Yamamoto Naoyoshi
Organization National Institute of Quantum and Radiological Science and Technology
Division name Hospital of the National Institute of Radilogical Sciences
Address Anagawa 4-9-1, Inage-ku 263-8555 Chiba, Japan
TEL 043-206-3360
Homepage URL
Email yamamoto.naoyoshi@qst.go.jp

Sponsor
Institute Hospital of the National Institute of Radilogical Sciences, National Institute of Quantum and Radiological Science and Technology
Institute
Department

Funding Source
Organization Hospital of the National Institute of Radilogical Sciences, National Institute of Quantum and Radiological Science and Technology
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 10 Month 01 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2017 Year 09 Month 04 Day
Anticipated trial start date
2017 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2017 Year 09 Month 20 Day
Last modified on
2017 Year 09 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033378

Research Plan
Registered date Registrant File name

Research case data specifications
Registered date Registrant File name

Research case data
Registered date Registrant File name


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