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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035093
Receipt No. R000040005
Official scientific title of the study An observational study to optimize first-line treatment for human papilloma virus-related oropharyngeal carcinoma recorded in the Head and Neck Cancer Registry of Japan
Date of disclosure of the study information 2018/12/01
Last modified on 2018/12/01

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Basic information
Official scientific title of the study An observational study to optimize first-line treatment for human papilloma virus-related oropharyngeal carcinoma recorded in the Head and Neck Cancer Registry of Japan
Title of the study (Brief title) An observational study for human papilloma virus-related oropharyngeal carcinoma recorded in the Head and Neck Cancer Registry of Japan
Region
Japan

Condition
Condition HPV related oropharyngeal carcinoma
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Among patients registered in the multicenter cancer registry of Japan, we will investigate the optimal treatment for human papilloma virus (HPV)-related oropharyngeal carcinoma taking into consideration the survival period and quality of life (QOL) according to clinical stages.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall survival period
Key secondary outcomes Local progression-free survival period
Progression-free survival period
Proportion of nutritional support-free survival

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 Presence of primary oropharyngeal neoplasm.
The neoplasm is pathologically confirmed as squamous cell carcinoma (SCC).
Histopathologically confirmed 75 % or more of the cancer tissue is p16-positive by immunostaining, irrespective of the assessment time.
Consent to participate in the present trial is obtained at the time of enrollment.
Patients with oropharyngeal cancer registered after 2011 in the multicenter cancer registry of Japan.
Key exclusion criteria History of treatment for head and neck cancer.
Presence of active double cancer (synchronous double cancer, or metachronous double cancer with disease-free period of less than five years. However, lesions corresponding to carcinoma in situ, and mucosal carcinoma judged as cured by localized treatment will not be included as active double cancer)
When the attending physician judges participation in the present study to be unsuitable.
Target sample size 636

Research contact person
Name of lead principal investigator Katsunari Yane
Organization Nara Hospital Kindai University Faculty of Medicine
Division name Otorhinolaryngology
Address 1248-1 Otoda-cho, Ikoma-shi, Nara prefecture
TEL 0743-77-0880
Email kyane@med.kindai.ac.jp

Public contact
Name of contact person Katsunari Yane
Organization Nara Hospital Kindai University Faculty of Medicine
Division name Otorhinolaryngology
Address 1248-1 Otoda-cho, Ikoma-shi, Nara prefecture
TEL 0743-77-0880
Homepage URL
Email kyane@med.kindai.ac.jp

Sponsor
Institute Japan Society for Head and Neck Cancer
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2018 Year 12 Month 01 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 07 Month 30 Day
Anticipated trial start date
2018 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
2018 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information For the patient background survey, first line treatment details survey, and prognosis survey, we will access the link only available for members on the Japan Society for Head and Neck Cancer's website, and log into the UMIN INDICE enrollment server with the password.

Management information
Registered date
2018 Year 12 Month 01 Day
Last modified on
2018 Year 12 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040005

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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