Induction Chemotherapy Followed by Chemoradiation With Cetuximab in Head and Neck Cancer

Inclusion Criteria:

• Squamous cell carcinoma, histologically proven
• Tumour site: oral cavity, oropharynx, hypopharynx or larynx.
• Locally and/or regionally inoperable tumors (UICC TNM stages IVa or IVb) - - without distant metastases (M0-stage)
• Male or female ≥18 years of age
• Expected survival >6 months
• Presence of at least one bidimensionally measurable index lesion
• Effective contraception for both male and female subjects if risk of conception exists
• WHO performance status 0-2
• Laboratory parameters:

hemoglobin ≥100 g/L leukocyte count > 3.5x109/L, absolute neutrophil count ≥ 1.5x109/L platelet count > 100x109/L total bilirubin < 1.25x upper normal limit transaminases (ALT, AST) < 5x upper normal limit creatinine clearance ≥ 55 mls/minute

• Signed written informed consent

Exclusion Criteria:

• Metastatic disease
• Squamous cell carcinoma of the nasopharynx and nasal cavity and paranasal sinuses
• ChT or XRT ineligibility:

Unstable cardiac disease or any other medical condition likely to compromise the safe delivery of ChT or XRT; Clinically evident hearing impairment; Pre-existing motor or sensory neurotoxicity grade ≥ 2 according to the CTCAE v3.0;

• Any kind of previous therapy for SCCHN (excluding diagnostic biopsy)
• Previous administration of EGFR pathway-targeting therapy
• Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy which is not part of the study protocol
• Participation in another clinical trial within 30 days prior to study entry
• Pregnancy or breast feeding
• History of severe acute pulmonary disease
• Any investigational agent within past 30 days
• Other previous malignancy within 5 years, with exception of a history of a previously adequately treated basal cell carcinoma of the skin or pre- invasive carcinoma of the cervix
• Known drug abuse / severe alcohol abuse
• Legal incapacity or limited legal capacity
• Medical or psychological condition which in the opinion of the investigator would not permit the subject to complete the study or sign meaningful informed consent
• Active, uncontrolled infection
• Other medical condition or other therapy that in the opinion of the investigator precludes the safe administration of the planned ChT and XRT