oropharyngeal squamous cell carcinoma
Conditions
Interventions
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
Sponsors
Kobe City Medical Center General Hospital, Head and Neck Department
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological response obtained by operative specimen after 2 cycles of neo-adjuvant chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactShogo Shinohara
Kobe City Medical Center General Hospital Department of Head and Neck Surgery
Outcome results
None listed