head and neck cancer
Conditions
Interventions
S-1 is administered orally at 60 mg/m2 for 14 consecutive days followed by a 7 days rest. A total radiation dose of 70 Gy is planned with conventional fractionation (1.8-2.0Gy/day). Cycles are repeate
Sponsors
Yokohama City University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)histologically or cytologically confirmed squamous cell carcinoma 2)stage II (T2N0M0) laryngeal, mesopharunx, and hypopharynx cancer with no evidence of distance metastases. 3)age: >=20 and <80 4)with measurable region 5)without prior treatment 6)Performance Statues: 0-1(ECOG) 7)sufficient function of important organs a)WBC: >=4,000/mm3 and <=12,000/mm3 b)Neutrophyl: >=2,000/mm3 c)Platelet: >=100,000/mm3 d)Hemoglobin: >=10g/dl e)GOT, GPT: 2.0 times of normal range in each institute f)ALP: 2.0 times of normal range in each institute g)sT.bil: 2.0 times of normal range in each institute h)sCreatinin: normal range in each institute i)Ccr: >=60 ml/min/body 8)expected more than 3 months survival from drug administration 9)written informed consent 10)with ability of oral intake
Exclusion criteria
Exclusion criteria: 1)with active double cancer 2)with severe complications (congested heart failure, coronary insufficiency, myocardial infarction, angina pectoris or abnormal cardiac rhythm which need to treat, history of cerebrovascular accident, hemorrhagic gastrointestinal ulceration, uncontrolled diabetes, renal failure, active hepatitis, liver cirrhosis) 3)with develop 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 and men with partner willing to get pregnant 7)with interstitial pneumonitis which is revealed from chest X ray and chest CT 8)with history of mental disorder or treating it at the moment 9)with history of severe allergy 10)with severe allergy to S-1 11)patients receiving 5-FU based chemotherapy 12)patients receiving Flucytosine 13)doctor's decision not to be registered to this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| local control rate | — |
Secondary
| Measure | Time frame |
|---|---|
| response rate, treatment completion rate, local control time, progression free time, overall survival, safety | — |
Countries
Japan
Contacts
Public ContactTakahide Taguchi
Yokohama City University Hospital Department of Otorhinolaryngology
Outcome results
None listed