advanced squamous cell carcinoma of the head and neck
Conditions
Interventions
The chemotherapy regimen consisted of combination of three drugs: docetaxel (50mg/m2, day1), cisplatin (60mg/m2, day1), and weekly cetuximab (week 1, 400mg/m2, subsequent weeks, 250mg/m2). Two cycles
Sponsors
Department of Biology and Function in the Head and Neck, Yokohama City University Graduate School of Medicine
Department of Otorhinolaryngology, Yokohama City University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) histologically or cytologically confirmed squamous cell carcinoma of the head and neck 2) primary site is oral cavity, oropharynx, hypopharynx, or larynx 3) stage III, IVA, or IVB 4) age of 20-70 years 5) Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 resectable or unresectable cases 6) cases with measurable or assessable region (RECICT v1.1) 7) untreated cases with first cancer 8) sufficient function of important organs a) WBC: >=3,000/mm3 b) Neutrophyl: >=1,500/ mm3 c) Platelet: >=100,000/ mm3 d) Hemoglobin: >=9.0 g/dl e) AST, ALT: <=3 times the upper limited of the normal range f) sT.bil: <=2 times the upper limited of the normal range g) Creatinin clearance: <=65 ml/min 9) HBsAg negative 10) written informed consent
Exclusion criteria
Exclusion criteria: 1) with distant metastasis 2) nasopharyngeal cancer 3) post-operative chemoradiotherapy 4) with treatment history of cetuximab or with allergy to taxan, platinum analogue, or cetuximab or with a history of allergy 5) creatinin clearance < 65ml/min 6) with heart disease which is difficult to control 7) with interstitial pneumonitis or pulmonary fibrosis 8) with diabetic, hypertension, or liver dysfunction which is difficult to control 9) with infection which need to treat 10) with severe drug allergy 11) pregnant, women who like be pregnant, or man who doesn't agree to contraception during the treatment 12) doctor's decision not to be registered to this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety acute adverse event (neutropenia) during primary treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| response rate, treatment comprehensive rate, disease-free survival, Overall survival | — |
Countries
Japan
Contacts
Public ContactOridate Nobuhiko
Yokohama City University Graduate School of Medicine Department of Biology and Function in the Head and Neck
Outcome results
None listed