UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042262 |
|---|---|
| Receipt number | R000048251 |
| Scientific Title | Dosimetric analysis of Eustachian tube dysfunction and otitis media with effusion after carbon-ion radiotherapy for head and neck cancer |
| Date of disclosure of the study information | 2021/01/01 |
| Last modified on | 2021/05/24 16:16:44 |
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Basic information
Public title
Dosimetric analysis of Eustachian tube dysfunction and otitis media with effusion after carbon-ion radiotherapy for head and neck cancer
Acronym
Dosimetric analysis of Eustachian tube dysfunction and otitis media with effusion after carbon-ion radiotherapy for head and neck cancer
Scientific Title
Dosimetric analysis of Eustachian tube dysfunction and otitis media with effusion after carbon-ion radiotherapy for head and neck cancer
Scientific Title:Acronym
Dosimetric analysis of Eustachian tube dysfunction and otitis media with effusion after carbon-ion radiotherapy for head and neck cancer
Region
| Japan |
Condition
Condition
head and neck cancers.
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify predictive factors for Eustachian tube disfunction and OME in patients treated with carbon-ion radiotherapy for head and neck cancers.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence rate of otitis media with effusion after carbon-ion radiotherapy.
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
Patients with head and neck cancers treated with CIRT between October 2013 and December 2018 in our institution.
Key exclusion criteria
(1) parotid or external ear canal cancers; (2) less than 6 months follow-up; (3) the tumor invasion of either Eustachian tube, internal ear, middle ear cavity or external ear canal; (4) identification of mastoid cell opacification before CIRT; (5) less than 10% irradiation dose of the Eustachian tube or mastoid cell; and (6) the history of radiotherapy to the head and neck region.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | takashi |
| Middle name | |
| Last name | kaneko |
Organization
QST hospital
Division name
Department of treatment
Zip code
263-8555
Address
tiba city inage district anagawa 4-9-1
TEL
043-206-3306
kaneko.takashi@qst.go.jp
Public contact
Name of contact person
| 1st name | takashi |
| Middle name | |
| Last name | kaneko |
Organization
QST hospital
Division name
Department of treatment
Zip code
263-8555
Address
tiba city inage district anagawa 4-9-1
TEL
043-206-3306
Homepage URL
kaneko.takashi@qst.go.jp
Sponsor or person
Institute
QST hospital
Institute
Department
Personal name
Funding Source
Organization
none.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
QST hospital
Address
tiba city inage district anagawa 4-9-1
Tel
043-206-3306
kaneko.takashi@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
| 2021 | Year | 01 | Month | 01 | 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
141
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 12 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 31 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | 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
| 2020 | Year | 10 | Month | 27 | Day |
Last modified on
| 2021 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048251
