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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000042262
Receipt No. 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

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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
Email 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
Email kaneko.takashi@qst.go.jp

Sponsor
Institute QST hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048251

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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