Study of Combination Docetaxel and Radiotherapy With or Without Cisplatin to Treat Local Advanced Head and Neck Cancer

Inclusion criteria

• Patients with locally advanced head and neck cancer (T3 and T4 tumors), epidermoid, histologically proven without metastasis; the primitive site of which is the oral cavity, the oropharynx, the hypopharynx or the larynx.
• Locally advanced tumors which are inoperable, or operable but the patient refuses surgery.
• Age ≥ 18 years and ≤ 70 years.
• PS < 2.
• Satisfactory hematological, hepatic and renal functions: (PN ≥ 2000/mm3, platelet count ≥ 100,000/mm3, hemoglobin ≥ 10g/dl, serum creatinine ≤ 120 µmol/l or creatinine clearance ≥ 60 ml/mn, normal total bilirubin, AST (SGOT) and ALT (SGPT) ≤ 2.5 x the upper limit of normal (ULN) of each center, PAL ≤ 5 x LNS; patients with AST or ALT > 1.5 x LNS combined with PAL > 2.5 x LNS will not be eligible for this trial.

Exclusion criteria

• Any metastases (other than cervical ganglia).
• Cancer of the cavum and the facial structure.
• Any previous chemotherapy or radiotherapy, irrespective of the reason.
• Any surgery for epidermoid carcinoma in the upper aerodigestive tracts.
• Weight loss ≥10% of total body weight during the last 3 months.
• Any other previous cancer excepting in situ or cutaneous cervical cancer (spinocellular or basocellular).
• Pregnant or nursing women; women of childbearing potential must use an appropriate method of contraception.
• Poorly controlled progressive infection.
• Peripheral neuropathy with NCI grade ≥ 2.
• Neurological or psychiatric disease (dementia, seizures, etc.) that is not compatible with good understanding and sufficient compliance with treatment.
• Any other poorly controlled progressive disease, such as heart failure, symptomatic cardiac rhythm disorders, progressive angina pectoris, or respiratory impairment.
• Any other concomitant investigational treatment.
• Any other concomitant anticancer treatment.
• Allergy to polysorbate 80.
• Definitive formal contraindication to corticosteroids.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.