Head and neck squamous cell carcinoma at stage III and IV
Conditions
Interventions
Concurrent chemoradiotherapy Radiotherapy: 2Gy/fraction/day, 5fractions/week, total dose of 60-70Gy/30-35fractions for non-nasopharyngeal cancer, or 1.8Gy/fraction/day, 5fractions/week, total dose o
Sponsors
Department of Otorhinolaryngology and Head and Neck Surgery, Osaka University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) no tumor-specific pretreatment 2) no prior radiation against the same field as currently scheduled 3) estimable or measurable lesion 4) Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 5) expected survival duration for > 3months after the biginning of the treatment 6) no major impairment of liver, kidney, or bone marrow, fulfilling the condition of AST/ALT <2times the upper limit of normal, BUN <25mg/dl, serum creatinine <1.5mg/dl, creatinine clearance >60ml/min, white blood cell count >4000/mm3, neutrophil count >2000/mm3, and platelet count >100,000/mm3 7) no evidence of active infection or fever >38C 8) written informed consent
Exclusion criteria
Exclusion criteria: 1) interstitial pneumonia or pulmonary fibrosis evidenced by chest X-ray and/or chest CT 2) major heart/lung disorders, or uncontrolled diabetes mellitus 3) distant metastases or second primary cancer except when there has been no evidence of the disease for more than 24 months without any treatment and when the disease is superficial 4) major pulmonary effusion or ascites 5) neuropathy or edema 6) pregnancy or lactation 7) history of major allergy to medicine 8) long use of steroid
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Survival rate, organ preservation rate, safety | — |
Countries
Japan
Contacts
Public ContactHidenori Inohara
Osaka University School of Medicine Department of Otolaryngology
Outcome results
None listed