A Study of Cisplatin Plus Radiotherapy Compared to Cetuximab Plus Radiotherapy in Locally Advanced Head and Neck Cancer.

Exclusion Criteria

• •Previous malignant disease in the head and neck region, with exception for basal cell carcinoma or curatively treated squamous cell carcinoma of the skin with follow-up time of at least 3 years
• •Concomitant or previous malignancies. Exceptions are adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, or in situ carcinoma of the cervix uteri, or other previous malignancy with a disease-free interval of at least 5 years
• •Two or more synchronous primary head and neck squamous cell cancer at time of diagnosis
• •Co-existing disease prejudicing survival (expected survival less than 6 months)
• •Absolute neutrophil count less than 1.5 x 109/L
• •Platelet count less than 100 x 109/L
• •Bilirubin over 1.5 times upper limit of normal
• •Aspartate aminotransferase (ASAT) or Alanine aminotransferase (ALAT) more than 3 times upper limit of normal
• •Pregnancy or lactation
• •Allergy to study drug or to the excipients in their formulation
• •Neuropathy grade 2 or more according to Common terminology criteria for adverse events (CTCAE) v.4.0
• •Severe cardiac illness; myocardial infarction within 6 months prior to randomization, severe congestive heart failure, severe cardiomyopathy, ventricular arrythmia, unstable angina, uncontrolled hypertension