Patients will be randomised after surgery, provided surgery is macroscopically adequate, that there is a flap of tissue protecting the vascular axis and that wound healing allows reirradiation to begin less than 8 weeks after surgery.Reirradiation will begin in the two arms less than 8 weeks after surgery in the irradiated area. The reirradiated volume : tumour bed + a safety margin of \< 2 cm with immediate protection of bone marrow. This volume should be jointly defined by the radiotherapist and the surgeon. During reirradiation, 60 Gy will be delivered in the two arms but will last 11 weeks in the reference arm and 5 weeks in the investigational arm.Acute toxicity (NCI-CTCAE) will be evaluated at the end of reirradiation and at 6 months from randomization (first follow-up consultation)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
single-fraction radiotherapy with concomitant 5FU and Hydrea
hyperfractionated radiotherapy with concomitant Cetuximab
Institut Gustave Roussy
Villejuif, France
Acute toxicity requiring an interruption of radiotherapy for more than 2 weeks
Time frame: 6 months
Overall survival at 3 years and loco-regional control at 3 years
Time frame: 3 years
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