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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000013476
Receipt No. R000015733
Scientific Title The effect of multimodality treatment and HPV infection in oropharyngeal squamous cell carcinoma.
Date of disclosure of the study information 2014/06/01
Last modified on 2014/03/21

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Basic information
Public title The effect of multimodality treatment and HPV infection in oropharyngeal squamous cell carcinoma.
Acronym Multimodality treatment and HPV in oropharyngeal cancer
Scientific Title The effect of multimodality treatment and HPV infection in oropharyngeal squamous cell carcinoma.
Scientific Title:Acronym Multimodality treatment and HPV in oropharyngeal cancer
Region
Japan

Condition
Condition Oropharyngeal squamous cell carcinoma
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We study an association between effect on oropharyngeal squamous cell carcinoma and HPV infection of the treatment mainly on the chemoradiotherapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The efficacy of multi modality treatment and HPV detection in cancer cells
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment
Interventions/Control_1 chemotherapy, chemoradiotherapy
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
18 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Squamous cell carcinoma of oropharynx
Stage III/IV
PS 1 OR 2
No prior treatment
Key exclusion criteria Patients with surgical treatment
Distant metastasis
Double cancer
Target sample size 213

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masato Fujii
Organization National Hospital Organization Tokyo Medical Cencter
Division name Otolaryngology
Zip code
Address Meguro TOKYO
TEL 03-3411-0111
Email fujiimasato@kankakuki.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masato Fujii
Organization National Hospital Organization Tokyo Medical Cencter
Division name Otolaryngology
Zip code
Address Meguro TOKYO
TEL 03-3411-0111
Homepage URL
Email fujiimasato@kankakuki.go.jp

Sponsor
Institute The study group of basic research of the head and neck
Institute
Department

Funding Source
Organization National Hospital Organization Tokyo Medical Cencter
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
2014 Year 06 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
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
2014 Year 03 Month 03 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 03 Month 21 Day
Last modified on
2014 Year 03 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015733

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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