Cetuximab Compared to Mitomycin-C and 5-Fluorouracil for Locally Advanced Squamous Cell Carcinomas of the Head and Neck

Inclusion Criteria: * must have a non-resectable cancer of head and neck * must have a pathologically proven squamous cell carcinoma arising in the oropharynx, oral cavity, hypopharynx, or larynx or cancer of unknown primary site * must have a stage III or IV disease with an expected survival time of ≥ 12 months with node status of N0-N2 * must be medically suitable to withstand a course of definitive radiation therapy and concomitant chemotherapy or antibody-therapy * must have a Karnofsky performance status (KPS) of ≥ 70 at the time of screening * must be between ≥18 and ≤80 years of age * must have the following laboratory values: Analysis/International System of Units (SI units) Neutrophil count/≥ 1.5 G/l Platelet count/≥ 100 G/l Serum glutamate oxaloacetate transaminase (SGOT)/≤ 2 x the upper limit of normal Serum glutamate pyruvate transaminase (SGPT)/≤ 2 x the upper limit of normal Serum creatinine or estimated creatinine clearance/≤ 1.5mg/dl or Epidermal growth factor receptor (eGFR)≥ 50 ml/min/1.73m² Serum calcium/Within normal limits * must be disease free from a previously treated malignancy for more than three years * must provide a signed and dated written informed consent * Female subject of childbearing potential must: * Understand that the study medication could have an expected teratogenic risk * Agree to use, and be able to comply with, effective contraception without interruption, 4 weeks before starting study drug, throughout study drug therapy (including dose interruptions) and for 3 months after the end of study drug therapy, even if she has amenorrhoea. This applies unless the subject commits to absolute and continued abstinence confirmed on a monthly basis. The following are effective methods of contraception\* Implant Levonorgestrel-releasing intrauterine system (IUS) Medroxyprogesterone acetate depot Tubal sterilisation Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses Ovulation inhibitory progesterone-only pills (i.e., desogestrel) \* Combined oral contraceptive pills are not recommended. If a subject was using combined oral contraception, she must switch to one of the methods above. The increased risk of venous thromboembolism (VTE) continues for 4 to 6 weeks after stopping combined oral contraception. * Agree to have a medically supervised pregnancy test with a minimum sensitivity of 25 milli-International units (mIU)/ml not more than 3 days before the start of study medication once the subject has been on effective contraception for at least 4 weeks. This requirement also applies to women of childbearing potential who practice complete and continued abstinence. * Agree to have a medically supervised pregnancy test every 4 weeks including 3 months after the end of study treatment, except in the case of confirmed tubal sterilization. These tests should be performed not more than 3 days before the start of next treatment. This requirement also applies to women of childbearing potential who practice complete and continued abstinence * Male subject must: * Agree to use condoms throughout study drug therapy, during any dose interruption and for up to 3 months after cessation of study therapy if his partner is of childbearing potential and has no contraception. * Agree not to donate semen during study drug therapy and for one week after end of study drug therapy. Exclusion Criteria: * Evidence of distant metastatic disease * Prior systemic chemotherapy within the last three years * Previous surgery for the tumor under study, other than biopsy and debulking of squamous cell carcinoma arising in the larynx * Prior radiation therapy to the head and neck * Receiving radiation therapy as part of a postoperative regimen following primary surgical resection * Pregnancy or breastfeeding * Patient received prior Cetuximab or murine monoclonal antibody therapy * Patient received prior Mitomycin-C and 5-Fluorouracil * Actual hemorrhages * Stomatitis, ulcerations in the mouth and the gastrointestinal tract * Actual severe diarrhea * Severe infectious diseases (Hepatitis A, B, C, D HIV) * Coagulation disorders * Active vaccination * Patient has a medical or psychological condition that would not permit the patient to complete the trial or sign the informed consent * Active participation in another clinical trial