UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013476 |
|---|---|
| Receipt number | 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 09:28:23 |
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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
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
fujiimasato@kankakuki.go.jp
Sponsor or person
Institute
The study group of basic research of the head and neck
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015733
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
