Postoperative Concurrent Chemoradiotherapy With Docetaxel for High-Risk Squamous Cell Carcinoma of Head and Neck

Inclusion criteria

• Histologically confirmed squamous cell carcinoma of the head and neck.Site of tumor origin in the oral cavity, oropharynx, larynx, or hypopharynx (excluding nasopharynx, or sinuses)
• Gross total resection, with pathology demonstrating one or more of the following risk factors:

• Histologic extracapsular nodal extension
• Histologic involvement of ≥ 2 regional lymph nodes
• Invasive cancer seen on microscopic evaluation of the resection margin, with no evidence of gross tumor residual
• No evidence of distant metastases
• No synchronous or concurrent head and neck primary tumors
• Karnofsky score over 60
• Adequate organ function including the following:

• Absolute neutrophil count (ANC) >= 1.5 * 10^9/l
• Platelets count >= 100 * 10^9/l
• Hemoglobin >= 10 g/dl
• AST and ALT <= 2.5 times institutional upper limit of normal (ULN)
• Total bilirubin <= 1.5 times institutional ULN
• Creatinine clearance >= 50 ml/min
• Serum creatine <= 1 times ULN
• Signed written informed consent

Exclusion criteria

• Evidence of distant metastasis
• Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region
• Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma
• Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures
• Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia