A Phase III Randomized Multicenter Study,Comparing an Induction Chemotherapy Followed by Irradiation and Concurrent Erbitux Versus Chemoradiotherapy for Patients With 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 .
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete response rate of the treatment
measure of the tumor
by CT scan or MRI and endoscopy 2 years after the end of treatment
No
Lionnel GEOFFROIS, oncologist
Study Director
Centre Alexis Vautrin NANCY France
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
GORTEC 2007-02
NCT01233843
May 2009
May 2015
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