Trial Comparing Two Protocols of re Irradiation in an Irradiated Area for Carcinoma of the Upper Aerodigestive Tract

Inclusion criteria

• Recurrent or second upper aerodigestive tract carcinoma in an area previously irradiated at a dose of >= 50 Gy
• Squamous cell carcinoma
• No grade III or IV sequels linked to the first radiation therapy (excepted radiation sequels of salivary glands)
• Relapse or second carcinoma (clinically invasive and/or lymph node recurrence >= 3 cm and/or the association of a local and lymph node recurrence
• Oral cavity, pharynx, larynx (if rT4), cervical region (if >3cm)
• No distant metastases confirmed by chest CT scan, abdominal ultrasound (or CT scan) in case of abnormal liver function, and bone scintigraphy in case of local symptoms
• Surgery in the previously irradiated region allowing a macroscopically adequate resection
• Surgery and vascular protection with a myocutaneous or free flap
• Interval > = 6 months between the end of the first radiation treatment and surgery in the previously irradiated area
• Wound healing allowing reirradiation within an interval of 8 weeks after surgery in the previouly irradiated area.
• No participation in a clinical trial during the 30 days preceding inclusion
• Age between 18 et 70 years.
• Performance Status 0 or 1 according to WHO criteria.
• Hematological function : neutrophils * 2 x 106/l, platelets : * 100 x 106/l, hemoglobin : * 10 g/dl (or 6.2 mmol/l)
• Liver function : total bilirubin (normal) ; ASAT (SGOT) and ALAT (SGPT) * 2.5 * upper limit of normal (ULN) in each centre ; alkaline phosphatases * 5 * ULN. Patients whose ASAT or ALAT levels > 1.5 * ULN associated with alkaline phosphatases * 2.5 * ULN are not eligible for the trial
• Renal function : serum creatinine * 120 *mol/l (1.4 mg/dl) ; if creatinine level is > 120 *mol/l, creatinine clearance should be * 60 ml/min.
• Written consent of participants

Exclusion criteria

• Superficial recurrence not associated with a lymph node relapse, isolated lymph node recurrence measuring less than 3 cm
• Distant metastases
• Grade 3 or 4 sequels of first radiation therapy (excepted salivary gland sequels)
• Macroscopically inadequate surgery
• Delay in wound healing obliging reirradiation to be postponed beyond 8 weeks.
• > Grade 3 Toxicity induced by chemotherapy administered during a previous treatment
• Hypersensitivity to Erbitux
• Concomitant severe comorbidities (non exhaustive list)
• Unstable cardiac comorbidity in spite of treatment.
• Neurological or psychiatric history such as dementia, convulsions.
• Severe uncontrolled infection
• Obstructive bronchopneumopathy which required hospitalisation during the year preceding inclusion.
• Factors (psychological, familial, social or geographic) likely to hinder patient compliance with the study protocol and follow-up are considered exclusion criteria. These factors should be discussed with the patient before enrollment in the trial
• Women who are pregnant, breast-feeding or of birthgiving age without effective contraception