advanced head and neck squamous cell carcinoma
Conditions
Interventions
Administration of 2 courses (6 weeks) concurrent chemotherapy in which one course consists of S-1 65mg/m2 for 2 weeks administration followed by 1 week rest. A total radiation dose of 70 Gy is planne
Sponsors
Yokohama City University hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. histologically or cytologically confirmed squamous cell carcinoma 2. Primary lesion located in oropharynx, hypopharynx, or larynx diagnosed as stage III, IVA or IVB with no evidence of distant metastases 3. Age of more than 76 years, or who is note eligible for concurrent chemoradiotherapy with TPF regimen 4. measurable or assessable region 5. previously untreated 6. ECOG performance status are 0 or 1. 7. With adequate major organ functions within 14 days before trial entry, as defined below: 1) White blood cell count >= 3,000/mm3, 12,000/mm3 < 2) Neutrophil count >=2,000/ mm3 3) Platelet count >=100,000/ mm3 4) Hemoglobin >=10.0 g/dl 5) AST, ALT: 2.0 times of normal range in each institute 6) ALP: 2 times of normal range of each institute 7) T.bil: 1.5 times of normal range in each institute 8) serum Creatinine <=1.5 mg/dl 9) creatinine clearance >=30ml/min 8. expected more than 3 months survival from drug administration 9. written informed consent 10. Possible oral intake
Exclusion criteria
Exclusion criteria: 1. with active double cancer 2. with sever complications (for example ; malignant hypertension, congested heart failure, coronary insufficiency, myocardial infarction, angina pectoris, or abnormal cardiac rhythm which need to treat within 6 months, cerebrovascular accident within 6 months, cirrhosis, hemorrhagic gastrointestinal ulceration, diabetes that is loss of control, bleeding tendency) 3. with deverop fever and suspected infection 4. with motor palsy, peripheral neuropathy or edema (exclude the disorder which derives from primary disease) 5. with pleural effusion which need to treat or pericardial effusions 6. pregnant or nursing women or women who like be pregnant 7. with interstitial pneumonitis which is revealed from chest X ray or chest CT 8. with a history of mental disorder or treated it at the momen 9. with a history of sever drug allergy 10. with sever allergy to S-1 11. during any treatment with other pyrimidine analogue drug 12. during any treatment with Flucytosine 13. Physician concludes that the patient&#39;s participation in this trial is inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, treatment completion rate, Cause specific survival rate, Overall survival period, Safety | — |
Countries
Japan
Contacts
Public ContactDaisuke Sano
Yokohama City University, school of medicine Department of Otolaryngology - Head and Neck Surgery
Outcome results
None listed