Locally advanced head and neck squamous cell carcinoma
Conditions
Interventions
None listed
Sponsors
Yokohama City University hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Previously untreated patients with measurable lesions. 2. Pathologically confirmed head and neck squamous cell carcinoma (HNSCC). 3. Primary lesion located in maxillary sinus, oral cavity, nasopharynx, oropharynx, hypopharynx, or larynx. 4. Clinical or Pathological stage III, IVA or IVB. 5. Surgically resectable. 6. Age of 20-75 years. 7. ECOG performance status are 0 or 1. 8. 24-h creatinine clearance >=65 ml/min 9. 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 >= 2,500/mm3 3) Platelet count >= 100,000/mm3 4) Hemoglobin >= 9.0 g/dL 5) Total Bilirubin < 1.5 mg/dL 6) AST, ALT <= 100IU/L 7) serum Creatinine < 1.2 mg/dL 10. No severe complications 11. No concurrent malignancies in 3 years before trial entry 12. Written informed consent must be taken by patients
Exclusion criteria
Exclusion criteria: 1. History of the serious hypersensitivity for drugs used in this trial 2. The needs to use phenytoin or warfarin potassium during this trial. 3. 24-h creatinine clearance <65 ml/min 4. Active infection 5. Active digestive tract disorder 6. Evidence of interstinal lung disease, or pulmonary fibrosis 7. Evidence of uncontrolled diabetes mellitus 8. Evidence of uncontrolled cardiovascular disease 9. Severe hepatic dysfunction 10. Severe watery diarrhea 11. Lactating, pregnant or possibly pregnant women, or those willing to become pregnant 12. Physician concludes that the patient&#39;s participation in this trial is inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Locoregional free survival | — |
Countries
Japan
Contacts
Public ContactDaisuke Sano
Yokohama City University, school of medicine Department of Otolaryngology - Head and Neck Surgery
Outcome results
None listed