Randomized Phase 2 Trial Evaluating the Acute Toxicity of Two Protocols of Reirradiation After Surgery in an Irradiated Area for Carcinoma of the Upper Aerodigestive Tract - Single-fraction Radiotherapy With Concomitant 5FU and Hydrea Administered Every Other Week - Continuous Hyperfractionated Radiotherapy With Concomitant Cetuximab
- 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
- 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
- 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
- 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