UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility study of carbon-ion radiotherapy using the rotating gantry
Title of the study (Brief title)	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	Masashi Koto
Organization	National Institutes for Quantum and Radiological Sciences and Technology
Division name	Hospital of the National Institute of Radiological Sciences
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	Masashi Koto
Organization	National Institutes for Quantum and Radiological Sciences and Technology
Division name	Hospital of the National Institute of Radiological Sciences
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 04 Month 03 Day
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

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Publication of results	Unpublished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