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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035960
Receipt No. R000040952
Scientific Title Assessment of risk factors associated with development of oronasal fistula as a late complication after Carbon Ion Radiotherapy for Head and Neck Cancer
Date of disclosure of the study information 2019/02/20
Last modified on 2019/02/20

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Basic information
Public title Assessment of risk factors associated with development of oronasal fistula as a late complication after Carbon Ion Radiotherapy for Head and Neck Cancer
Acronym Assessment of risk factors associated with development of oronasal fistula as a late complication after Carbon Ion Radiotherapy for Head and Neck Cancer
Scientific Title Assessment of risk factors associated with development of oronasal fistula as a late complication after Carbon Ion Radiotherapy for Head and Neck Cancer
Scientific Title:Acronym Assessment of risk factors associated with development of oronasal fistula as a late complication after Carbon Ion Radiotherapy for Head and Neck Cancer
Region
Japan

Condition
Condition sinonasal and oral cavity cancers
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To find out the effect of dose volume relationship and the factors associated with development of oronasal fistula after carbon-ion radiotherapy.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes development of oronasal fistula
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 sinonasal carcinomas and oral cavity cancer patients treated with definitive carbon ion radiotherapy between 2006 - 2011 who were followed up for more than 5 years.
Key exclusion criteria inadequate evaluation for maxilla.
irradiated volume not including maxilla
Target sample size 60

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 043-206-3306
Email koto.masashi@qst.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Office of the hospital
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 043-206-3306
Homepage URL
Email koto.masashi@qst.go.jp

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

Funding Source
Organization National Institutes for Quantum and Radiological Sciences and Technology
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
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
2019 Year 02 Month 20 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 Preinitiation
Date of protocol fixation
2019 Year 02 Month 15 Day
Date of IRB
Anticipated trial start date
2019 Year 02 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2019 Year 02 Month 20 Day
Last modified on
2019 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040952

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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