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Recruitment status Completed
Unique ID issued by UMIN UMIN000017134
Receipt No. R000019863
Official scientific title of the study 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

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Basic information
Official scientific title of the study Clinical verification of respiratory synchronized irradiation system with high-speed scanning of heavy-ion beam in treatment for mobile target
Title of the study (Brief title) 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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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 Tsuji Hiroshi
Organization National Institute of Radiological Sciences
Division name Research center for charged particle therapy
Address 4-9-1 Anagawa Inage-ku Chiba Japan
TEL 043-206-3350
Email h_tsuji@nirs.go.jp

Public contact
Name of contact person Tsuji Hiroshi
Organization National Institute of Radiological Sciences
Division name Research center for charged particle therapy
Address 4-9-1 Anagawa Inage-ku Chiba Japan
TEL 043-206-3350
Homepage URL
Email h_tsuji@nirs.go.jp

Sponsor
Institute National Institute of Radiological Sciences
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 01 Month 22 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019863


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