UMIN-CTR Clinical Trial

Basic information
Public title	The study of the response to the chemotherapy using S-1 and CDGP for p16 positive/p53 negative oropharnygeal squamous cell carcinoma
Acronym	Chemotherapy for P16+/p53- OPSCC
Scientific Title	The study of the response to the chemotherapy using S-1 and CDGP for p16 positive/p53 negative oropharnygeal squamous cell carcinoma
Scientific Title:Acronym	Chemotherapy for P16+/p53- OPSCC
Region	Japan

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

Objectives
Narrative objectives1	To prove the effectiveness of de-intensive therapy to HPV related oropharyngeal squamous cell carcinoma by minimized operation after neo-adjuvant chemotherapy using S-1 and nedaplatin (CDGP), maintaining the quality of life of the patient
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Pathological response obtained by operative specimen after 2 cycles of neo-adjuvant chemotherapy
Key secondary outcomes	2-years disease free survival, QOL estimation using EORTC H&N35 score 2 years after the therapy, Response rate of the chemotherapy by RECIST, The relationship between SUV diminishing rate of FDG-PET/CT and pathological response, the relationship between pathological response and 2-years disease free survival

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Vaccine Maneuver
Interventions/Control_1	Chemotherapy S-1 80mg/m2, day1-4 CDGP 80mg/m2, day7 2 cycles with 3 weeks interval transoral surgery with or without neck dissection 3 weeks after 2nd chemotherapy
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	20 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	The patients with p16 positive p53 negative oropharyngeal squamous cell carcinoma (cT1-3, any N) who proved to have squamous cell carcinoma in primary site or cervical lymphnodes
Key exclusion criteria	The patients with any distant metastasis The patients who are pregnant or possibly pregnant The patients who have a history of surgery or radiation in the oropharynx The patients whose general conditions are too poor for chemotherapy The patients with some conditions which may disturb safety transoral surgery, such as under strong anticoagulants, with severe trismus and so on The patients who are judged to be inappropriate for the study
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shogo Shinohara
Organization	Kobe City Medical Center General Hospital
Division name	Department of Head and Neck Surgery
Zip code
Address	Minatojima-mimamimachi 2-1-1, Chuo-ku, Kobe
TEL	078-302-4321
Email	sinosino@kcho.jp

Public contact
Name of contact person	1st name Middle name Last name Shogo Shinohara
Organization	Kobe City Medical Center General Hospital
Division name	Department of Head and Neck Surgery
Zip code
Address	Minatojima-mimamimachi 2-1-1, Chuo-ku, Kobe
TEL	078-302-4321
Homepage URL
Email	sinosino@kcho.jp

Sponsor
Institute	Kobe City Medical Center General Hospital, Head and Neck Department
Institute
Department

Funding Source
Organization	Kobe City Medical Center General Hospital, Head and Neck Department
Organization
Division
Category of Funding Organization	Local Government
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	神戸市立医療センター中央市民病院（兵庫県）、尼崎総合医療センター（兵庫県）

Other administrative information
Date of disclosure of the study information	2016 Year 12 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	Terminated
Date of protocol fixation	2016 Year 10 Month 26 Day
Date of IRB	2016 Year 01 Month 10 Day
Anticipated trial start date	2017 Year 01 Month 01 Day
Last follow-up date	2020 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 11 Month 04 Day
Last modified on	2020 Year 05 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028394