Adjuvant Cetuximab and Chemoradiation in Head and Neck Cancer

Inclusion Criteria:

* Signed written informed consent;
* Males or females between 18 and 70 years of age;
* Surgically resected squamous cell carcinomas of the hypopharynx, oropharynx, larynx and oral cavity with high risk of locoregional recurrence not more than 6-9 weeks (maximum) ago;
* To be categorized as high risk patients have to fulfil at least one of the following criteria:

  * R0 - resection \<5 mm margin
  * R1 - resection
  * Extracapsular nodal extension;
* no previous chemotherapy, radiotherapy;
* Performance status ECOG: 0 - 1;
* Contraception in male and female patients if of childbearing potential, willingness to use effective contraceptive method for the study duration and 2 months post-dosing;
* Adequate renal, liver and hematological functions (within maximum 9 weeks until surgery):

  * Adequate bone marrow function: neutrophils \> 1.5 x 10\^9/L, platelets \> 100 x 10\^9/L, hemoglobin \> 10.0 g/dL
  * Adequate liver function: Bilirubin \< 2.0 mg/dL, AST, ALT, AP, γ-GT \< 3 x ULN
  * Adequate renal function: creatinine clearance \> =60 ml/min
* No distant metastases;

Exclusion Criteria:

* Nasopharyngeal carcinoma;
* R2 resection;
* Invalid informed consent;
* Performance Status \> 1;
* Previous chemotherapy or radiotherapy for carcinoma of the head and neck;
* Prior exposure to EGFR pathway targeting therapy;
* Other serious illness or medical conditions:

  * Unstable cardiac disease despite treatment, congestive heart failure NYHA grade 3 and 4;
  * Clinically significantly abnormal electrocardiogram (ECG) or left ventricular ejection fraction (LVEF) below the institutional range of the normal
  * Significant neurologic or psychiatric disorders including dementia or seizures;
  * Active uncontrolled infection;
  * Active disseminated intravascular coagulation;
  * Other serious underlying medical conditions which could impair the ability of the patient to participate in the study;
* Symptomatic peripheral neuropathy National Cancer Institute-Common Toxicity Criteria (NCI-CTC v3.0) grade 2 or ototoxicity grade 2, except if due to trauma or mechanical impairment due to tumor mass;
* Having participated in another therapeutic clinical trial or any investigational agent in the preceding 30 days;
* Known allergic/hypersensitivity reaction to any of the components of the treatment;
* Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding;
* Known drug abuse;
* Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix;
* Legal incapacity or limited legal capacity;
* Sensitivity and incompatibility against 5-Fluorouracil
* Sensitivity and incompatibility against platinum-compounds
* Known incompatibilities \>grade 3 towards cetuximab
* expected incompliance of patient (e.g. in case of severe alcohol addiction)
* Dental evaluation: Pre treatment dental care before start of radiochemotherapy (approximately 8 to 10 days lapse-time is needed for complete recovery before initiation of radiation therapy).