Randomized Phase III Trial Comparing Induction Chemotherapy Followed by Radiotherapy to Concomitant Chemoradiotherapy for Laryngeal Preservation in T3MO Pyriform Sinus Carcinoma
Objectives: To compare conventional radiotherapy with concurrent cisplatin to induction
chemotherapy with cisplatin fluorouracil followed by conventional radiotherapy. The primary
end point was the preservation of the larynx. The secondary end points included toxicity,
causes of death and survival rates.
Design: Multicenter prospective randomized phase III trial. Setting: Academic tertiary care
center. Patients: Seventy one adult patients with biopsy-proven previously untreated
resectable T3 with fixed cord involvement squamous cell carcinoma of the pyriform sinus.
Main Outcomes Measures: Patients were evaluated for toxic reactions, and organ preservation
and survival rates. Statistical analysis of overall survival and event free survival was
performed using the Kaplan Meier method.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary end point was to compare the two treatment arms to define the best schedule of preservation of an intact larynx.
Jean-Michel PRADES, Pr
CHU de SAINT-ETIENNE
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)