locally advanced head &
Conditions
Interventions
Control arm: S-1 40mg po, twice daily, days 1-14
and cisplatin 70mg/m2 div, day 8, every 4 weeks for 2 cycles
Mefenamic acid arm: S-1 40mg po, twice daily, days 1-14
cisplatin 70mg/m2 div, day 8
and Mefenamic acid 750mg daily in 3 divided portions every 4 weeks for 2 cycles
Cilostazol arm: S-1 40mg po, twice daily, days 1-14
and Cilostazol 200mg daily in 2 divided portions every 4 weeks for 2 cycles
Sponsors
Chiba University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Head and neck cancer 2) Squamous cell carcinoma confirmed by histological examination of the primary tumor 3) Biopsy specimen of the primary tumor available 4) Having a measuable disease 5) Resectable locally advanced disease for which induction chemotherapy is indicated 6) No indication of radiotherapy 7) Aadequate organ function 8) Age (years old): 20 or older 9) written informed consent
Exclusion criteria
Exclusion criteria: 1) Gastric ulcer 2) Severe hematological, hepatic, renal or cardiac disorder 3) History of severe hypersensitivity to the ingredients of an agent used in this study 4) Aspirin asthma or its history 5) Uncontrolled hypertension 6) History of diarrhea in the use of mefenamic acid or cilostazol 7) Receiving anticoagulant therapy 8) Bleeding or bleeding tendency 9) Congestive heart failure 10) Pregnant 11) Lactating women 12) Psychotic disorder 13) Receiving systemic steroid therapy 14) Patients with any other conditions whom the doctor determined to be inappropriate for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival time, progression-free survival time, and incidences of adverse events | — |
Countries
Japan
Contacts
Public ContactYuichi Takiguchi
Graduate School of Medicine, Chiba University Department of Medical Oncology
Outcome results
None listed