The study of the response to the chemotherapy using S-1 and CDGP for p16 positive/p53 negative oropharnygeal squamous cell carcinoma
Not Applicable
- Conditions
- oropharyngeal squamous cell carcinoma
- Registration Number
- JPRN-UMIN000024707
- Lead Sponsor
- Kobe City Medical Center General Hospital, Head and Neck Department
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pathological response obtained by operative specimen after 2 cycles of neo-adjuvant chemotherapy
- Secondary Outcome Measures
Name Time Method 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