Randomized Study Comparing Induction Chemotherapy With Docetaxel, Cisplatin, 5FU Versus Cisplatin, 5 FU in Patients With T3 and T4 Larynx and Hypopharynx Carcinoma
The purpose of the study is to compare two regimen of induction chemotherapy for patients
with T3 and T4 larynx or hypopharynx carcinoma that would be treated with total
laryngectomy. The aim of the study is to compare the standard regimen (Cisplatin + 5FU)
versus the TPF regimen (Taxotere + Cisplatin + 5FU). Responders to the induction treatment
are treated with radiation with a purpose of larynx preservation. Non responders patients
will be treated with total laryngectomy followed by postoperative radiation.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
3-years larynx preservation rate
Gilles Calais, MD
Principal Investigator
CHU Bretonneau
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
GORTEC 2000-01
NCT00169182
December 2000
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