TPF Plus Cisplatin and Radiotherapy vs TPF Plus Cetuximab and Radiotherapy to Treat Head and Neck Cancer.

This study is being sponsored by a cooperative medical group.

Inclusion criteria

• Before the beginning of protocol's specific procedures, the informed consent has to be obtained.
• Locally advanced cancer of head and neck (oral cavity, oropharynx, larynx and hypopharynx) stage III-IV, without evidence of metastasis.
• The tumor must be considered to be non-operable according to the criteria of the Northern California Oncology Group. The reason of non-surgical resection will be annotated in the CRF.

Criteria of non-surgical resection according to the NCOG:

3.1.Technically not resectable (includes: evidence of mediastinal dissemination; fixed tumor to the clavicle, base of the cranium or cervical vertebrae; affectation of the nasopharynx).

3.2.Medical criteria based on a low surgical curability. 3.3.Medical contraindication for the surgery.

• Epidermoid carcinoma histologically demonstrated
• Measurable disease according to the RECIST criteria .
• Men or women with age between 18 and 70 years, both inclusive.
• Functional condition index according to ECOG scale:0-1
• Patients in medical conditions to be able to receive treatment with TPF induction followed by normofractionated radiotherapy with cetuximab or cisplatin.
• Patients with adequate hematologic function: neutrophils superior or equal to 2 x 109, platelets superior or equal to 100 x 109, hemoglobin superior or equal to 10 g/dl.
• Adequate hepatic function: bilirubin lower or equal to 1 x top normal Limit, GOT and GPT lower or equal to 2,5 Top Normal Limit , alkaline phosphatase < 5 Top Normal Limit.
• Adequate renal function: creatinin <1,4 mg/dl (120 µmol/l); if the values are > 1,4 mg/dl, the clearance of creatinin will have to be > 60 ml/min (real or calculated for Cockcroft-Gault's method).
• Calcium lower or equal to 1,25 x top normal limit.
• Adequate nutritional condition: loss of weight <20% with relation to the theoretical weight and albumin superior or equal to 35 g/L.
• Patients must be accessible for the treatment and the follow-up.

Exclusion criteria

• Metastatic disease
• Surgical treatment, previous radiotherapy and/or chemotherapy for the study disease.
• Other tumor locations in head and neck that are not oral cavity, oropharynx, larynx, hypopharynx.
• Other stages that are not III or IVM0.
• Other previous and / or synchronic squamous carcinoma.
• Diagnosis of another neoplasia in the last 5 years, excepting carcinoma in situ of uterine neck and/or a cutaneous carcinoma basocellular properly treated.
• Active infection(at needs endovenous antibiotics), including active tuberculosis and diagnosed HIV.
• Not controlled hypertension defined as arterial systolic tension superior or equal to 180 mm Hg and / or diastolic arterial tension superior or equal to 130 mm Hg baseline.
• Pregnancy(absence must be confirmed with the test of beta-HCG) or period of lactation.
• Immunity systemic treatment, chronic and concomitant, or hormonal treatment of the cancer.
• Other antineoplastic concomitant treatments.
• Coronary clinically significant arteriopathy or precedents of myocardial infarction in the last 12 months or high risk of not controlled arrhythmia or cardiac not controlled insufficiency.
• Pulmonary obstructive chronic disease that had needed 3 or more hospitalizations in the last 12 months.
• Active non controlled peptic ulcer.
• Presence of a psychological or medical disease that could prevent to accomplish the study by the patient or to grant his/her signature in the informed consent form.
• Known drugs abuse (with the exception of excessive consumption of alcohol)
• Known allergic reaction to some of the components of the treatment of the study.
• Previous treatment with monoclonal antibodies or other transduction of the sign inhibitors or treatment directed against the EGFR.
• Any experimental treatment in 30 days before the entry in the study.