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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024707
Receipt No. R000028394
Scientific Title The study of the response to the chemotherapy using S-1 and CDGP for p16 positive/p53 negative oropharnygeal squamous cell carcinoma
Date of disclosure of the study information 2016/12/01
Last modified on 2016/11/04

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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 Open public recruiting
Date of protocol fixation
2016 Year 10 Month 26 Day
Date of IRB
Anticipated trial start date
2017 Year 01 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
2016 Year 11 Month 04 Day
Last modified on
2016 Year 11 Month 04 Day


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

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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