UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035960 |
|---|---|
| Receipt number | 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 | 2019/12/21 22:53:27 |
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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
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
koto.masashi@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum and Radiological Sciences and Technology
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2019 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 16 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 30 | Day |
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 | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040952
