laryngeal, oropharyngeal, and hypopharyngeal cancer
Conditions
Interventions
Docetaxel administration group: Administration of 5 courses (5 weeks) concurrent chemotherapy in which one course consists of docetaxel 12mg/m2 weekly. A total radiation dose of 70 Gy is planned with
Sponsors
study group of chemoradiotherapy of the head and neck cancer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)histologically or cytologically confirmed squamous cell carcinoma 2)stage 3 or 4 with no evidence of distant metastases 3)resectable squamous cell carcinoma 4)measurable or assessable region 5)Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 6)age of 20-85 years 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: >=11.0 g/dl e) AST, ALT: 2.0 times of normal range in each institute f) sT.bil: 1.5 times of normal range in each institute g) ALP: 2 times of normal range of each institute h) sCreatinin: <=1.5 mg/dl l) Ccr: >30ml/min 8)expected more than 3 months survival from drug administration 9)written informed consent
Exclusion criteria
Exclusion criteria: 1)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) 2)with deverop fever and suspected infection 3)with motor palsy, peripheral neuropathy or edema (exclude the disorder which derives from primary disease) 4)with pleural effusion which need to treat or pericardial effusions 5)with active double cancer 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 moment 9)with sever allergy to docetaxel or S-1, or with a history of sever allergy 10)doctor's decision not to be registered to this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| locoregional relapse free survival, survival with primary organ preservation, overall survival, treatment completion rate, incidence and severity of adverse events, economic analysis | — |
Countries
Japan
Contacts
Public ContactTakahide Taguchi
Yokohama City University Graduate School of Medicine Department of Biology and Function in the Head and Neck
Outcome results
None listed