The purpose of this study is to demonstrate that induction chemotherapy followed by radiation therapy plus Cetuximab will give better results than the validated treatment (chemoradiotherapy), for treatment of locoregional advanced head and neck cancers.
Concurrent chemoradiotherapy (radiotherapy+ carboplatin + 5FU) is a validated treatment for patients with locoregional advanced head and neck cancers. This study evaluates the outcome of induction chemotherapy (docetaxel, cisplatin, 5 FU) followed by radiation therapy + Erbitux for patients with head and neck carcinoma with almost one measurable lesion by RMI or CT scan. We hope we can improve the progression free survival of 14% at two years .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
370
70 mg per m2 and per day for four days. day 1; day 22; day 43
600mg per m2 per day for four days. 3 cycles day 1; day 22; day 43
total dose: 70 grays. The patient receives 2 grays per day; five days a week during 7 weeks
GIRARD CALAIS Marie-Helene
Tours, France
Complete response rate of the treatment
measure of the tumor
Time frame: by CT scan or MRI and endoscopy 2 years after the end of treatment
The second focus of this study is to compare Overall survival between the two arms . It is defined as the time from the date of randomization to the date of death from any cause.
Aftercare every six months
Time frame: Date of death
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