UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024707 |
|---|---|
| Receipt number | 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 | 2020/05/08 09:10:12 |
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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
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
sinosino@kcho.jp
Sponsor or person
Institute
Kobe City Medical Center General Hospital, Head and Neck Department
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028394
