Neoadjuvant Erbitux Based Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer

The primary endpoint of this study is the pathological complete response after neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy. The second endpoint of this study is the disease free survival rates (1, 2, 3, 5 years), locoregional control rates (1, 3, 5 years), overall survival rate (3, 5 years), and the safety.

Inclusion criteria

• Written informed consent prior to any study activities
• Age 18-75
• Histological/cytological and iconography confirmed squamous-celled oral/oropharyngeal cancer
• Stage Ⅲ/Ⅳa (T1-2, N1-2, M0 or T3-4, N0-2, M0, AJCC 2010), operable disease
• Karnofsky performance status (KPS) ≥70
• Adequate hematologic function: Neutrophils ≥1,500/mm^3, WBC >4,000/mm^3, Hb > 10 g/dL, platelet count >100,000/mm^3
• Hepatic function: ALAT/ASAT <2.5 times the upper limit of normal (ULN), bilirubin <1.5 x ULN
• Renal function: serum creatinine <1.5 x ULN
• Life expectancy ≥6 months

Exclusion criteria

• Evidence of distant metastatic disease and other oropharyngeal cancers
• Surgical procedure of the primary tumor or lymph nodes (except diagnostic biopsy) before study treatment
• Previous radiotherapy for the primary tumor or lymph nodes
• Previous exposure to epidermal growth factor-targeted therapy
• Prior chemotherapy or immunotherapy for the primary tumor
• Other previous malignancy within 5 years, except non-melanoma skin cancer or pre-invasive carcinoma of the cervix
• Any investigational agent prior to the 1st study medication
• Participation in another clinical study within the 30 days prior to Inclusion in this study.
• Peripheral neuropathy >grade 1
• Known grade 3 or 4 allergic reaction to any of the study treatment
• History of severe pulmonary or cardiac disease
• Creatinine Clearance <30 ml/min
• Know drug abuse /alcohol abuse
• Legal incapacity or limited legal capacity
• Active systemic infection
• Medical or psychiatric illness, which in the investigators' opinions, would not permit the subject to complete or fully and completely understand the risks and potential complications of the study
• Concurrent chronic systemic immune therapy or hormone therapy not indicated in the study protocol
• Pregnancy (confirmed by serum or urine β-HCG) or lactation period
• Severe cardiac disease such as heart failure, clinical relevant cardiac dysrhythmias, coronary artery disease or myocardial infarction within the last 12 months