UMIN-CTR Clinical Trial

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