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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034858
Receipt No. R000039746
Scientific Title Retrospective study of carbon-ion radiotherapy for malignant tumor of sphenoid sinus
Date of disclosure of the study information 2018/11/11
Last modified on 2019/05/20

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Basic information
Public title Retrospective study of carbon-ion radiotherapy for malignant tumor of sphenoid sinus
Acronym Carbon-ion radiotherapy for malignant tumor of sphenoid sinus
Scientific Title Retrospective study of carbon-ion radiotherapy for malignant tumor of sphenoid sinus
Scientific Title:Acronym Carbon-ion radiotherapy for malignant tumor of sphenoid sinus
Region
Japan

Condition
Condition Malignant tumor of sphenoid sinus
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of carbon-ion radiotherapy for malignant tumor of sphenoid sinus
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall survival
Local control
Late toxicity
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Diagnosed as malignant tumor fo sphenoid sinus.
Case of Carbon-ion radiotherapy.
Key exclusion criteria Case of post-operative irradiation.
Case of Carbon-ion radiotherapy for recurrence.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Yasuhito
Middle name
Last name Hagiwara
Organization National Institutes for Quantum and Radiological Sciences and Technology
Division name Hospital of the National Institute of Radiological Sciences
Zip code 263-8555
Address Anagawa 4-9-1, Inage-ku 263-8555 Chiba, Japan
TEL 043-206-3360
Email hagiwara.yasuhito@gmail.com

Public contact
Name of contact person
1st name Yasuhito
Middle name
Last name Hagiwara
Organization National Institutes for Quantum and Radiological Sciences and Technology
Division name Hospital of the National Institute of Radiological Sciences
Zip code 263-8555
Address Anagawa 4-9-1, Inage-ku 263-8555 Chiba, Japan
TEL 043-206-3360
Homepage URL
Email hagiwara.yasuhito@gmail.com

Sponsor
Institute National Institutes for Quantum and Radiological Sciences and Technology
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization National Institutes for Quantum and Radiological Science and Technology Certified Review Board
Address Anagawa 4-9-1, Inage-ku 263-8555 Chiba, Japan
Tel 043-206-4706
Email helsinki@qst.go.jp

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
2018 Year 11 Month 11 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 22
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
2018 Year 10 Month 15 Day
Date of IRB
2018 Year 10 Month 15 Day
Anticipated trial start date
2018 Year 11 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2018 Year 11 Month 11 Day
Last modified on
2019 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039746

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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