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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000018108
Receipt No. R000020921
Scientific Title Feasibility study of planned neck dissection based on tumor HPV status in advanced oropharyngeal carcinoma receiving concurrent chemoradiotherapy
Date of disclosure of the study information 2015/06/29
Last modified on 2020/03/24

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Basic information
Public title Feasibility study of planned neck dissection based on tumor HPV status in advanced oropharyngeal carcinoma receiving concurrent chemoradiotherapy
Acronym Planned neck dissection in HPV-negative advanced oropharyngeal carcinoma receiving concurrent chemoradiotherapy
Scientific Title Feasibility study of planned neck dissection based on tumor HPV status in advanced oropharyngeal carcinoma receiving concurrent chemoradiotherapy
Scientific Title:Acronym Planned neck dissection in HPV-negative advanced oropharyngeal carcinoma receiving concurrent chemoradiotherapy
Region
Japan

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

Objectives
Narrative objectives1 Whether infection of human papillomavirus (HPV) can become the determinative in judging the need of planed neck dissection(PND) after concurrent chemoradiotherapy (CCRT) for the advanced oropharyngeal carcinoma with multple neck lymph node metastasis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes neck lymph node recurrence cumulative incidence rate
Key secondary outcomes overall survival
disease specific survival rate
recurrent free survival rate

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 HPV infection(+): planed neck dissection(-)

Interventions/Control_2 HPV infection(-): planed neck dissection(+)
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
20 years-old <
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1. The advanced oropharyngeal cancer patient determined by histopathological or cytologic examination, and has multiple neck lymph metastasis (N2b,N2c,and N3 stage).
2. The patient who agree with detecting HPV infection by p16 immunostaining, the HPV DNA in situ hybridization method, the PCR method.
3. The patient who have a measurable lesion or an evaluable lesion by RECIST.
4. Patient's age is older than 20 years old or younger than 80 years old.
5. The patient who accomplished concurrent chemoradiotherapy as primary treatment.
6. Performance status(ECOG) is 0 or 1.
7. The patient that the function of the main organ (heart, the lungs, the liver, kidney, marrow) maintained normal.
Key exclusion criteria 1. The patient who has severe complications.
2. The patient who has distant metastasis to other organs.
3. The patient who has treated by the radiation therapy to the irradiation part concerned.
4. The patient who have severe drug allergy.
5. The patient who have multiple primary cancer which is impossible to control except head and neck cancer.
6. The woman who has been pregnant or possiblity of pregnancy.
7. The patient who was judged inappropriate target by chief doctor or other doctors concerned with this study.
























































































Target sample size 60

Research contact person
Name of lead principal investigator
1st name Mikio
Middle name
Last name Suzuki
Organization Graduate school of medicine, university of the Ryukyus.
Division name Department of otorhinolaryngology, head and neck surgery
Zip code 903-0215
Address 207, Uehara, Nishihara city, Okinawa
TEL 098-895-1183
Email suzuki@med.u-ryukyu.ac.jp

Public contact
Name of contact person
1st name Hidetoshi
Middle name
Last name Kinjou
Organization University of Ryukyus hospital
Division name Department of otorhiolaryngology, head and neck surgery
Zip code 903-0215
Address 207, Uehara, Nishihara city, Okinawa
TEL 098-895-1183
Homepage URL
Email h111853@med.u-ryukyu.ac.jp

Sponsor
Institute Department of otorhinolaryngology, head and neck surgery,Graduate school of medicine, university of the Ryukyus.
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 ethic Committee of Ryukyu university
Address 207 Uehara,Nishihara-cho,Okinawa,903-0215,Japan
Tel 098-895-8016
Email knknkyu@to.jim.u-ryukyu.ac.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
2015 Year 06 Month 29 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 Open public recruiting
Date of protocol fixation
2015 Year 02 Month 20 Day
Date of IRB
2020 Year 03 Month 13 Day
Anticipated trial start date
2015 Year 06 Month 30 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 06 Month 26 Day
Last modified on
2020 Year 03 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020921

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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