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 |
The study of the response to the chemotherapy using S-1 and CDGP for p16 positive/p53 negative oropharnygeal squamous cell carcinoma
Chemotherapy for P16+/p53- OPSCC
The study of the response to the chemotherapy using S-1 and CDGP for p16 positive/p53 negative oropharnygeal squamous cell carcinoma
Chemotherapy for P16+/p53- OPSCC
Japan |
oropharyngeal squamous cell carcinoma
Oto-rhino-laryngology |
Malignancy
NO
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
Efficacy
Confirmatory
Pragmatic
Not applicable
Pathological response obtained by operative specimen after 2 cycles of neo-adjuvant chemotherapy
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Vaccine | Maneuver |
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
20 | years-old | <= |
75 | years-old | >= |
Male and Female
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
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
50
1st name | |
Middle name | |
Last name | Shogo Shinohara |
Kobe City Medical Center General Hospital
Department of Head and Neck Surgery
Minatojima-mimamimachi 2-1-1, Chuo-ku, Kobe
078-302-4321
sinosino@kcho.jp
1st name | |
Middle name | |
Last name | Shogo Shinohara |
Kobe City Medical Center General Hospital
Department of Head and Neck Surgery
Minatojima-mimamimachi 2-1-1, Chuo-ku, Kobe
078-302-4321
sinosino@kcho.jp
Kobe City Medical Center General Hospital, Head and Neck Department
Kobe City Medical Center General Hospital, Head and Neck Department
Local Government
NO
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)
2016 | Year | 12 | Month | 01 | Day |
Unpublished
Terminated
2016 | Year | 10 | Month | 26 | Day |
2016 | Year | 01 | Month | 10 | Day |
2017 | Year | 01 | Month | 01 | Day |
2020 | Year | 01 | Month | 01 | Day |
2016 | Year | 11 | Month | 04 | Day |
2020 | Year | 05 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028394