Phase III Trial of Intensity-modulated Radiotherapy Plus Cisplatin Versus Conventional Radiotherapy Plus Cisplatin in Patients With Stage III-IV Head and Neck Squamous Cell Carcinoma
This is a multicentric randomized phase III trial comparing intensity-modulated radiotherapy
plus concomitant cisplatin versus conventional radiotherapy plus concomitant cisplatin in
patients with stage III-IV squamous cell carcinoma of oral cavity, oropharynx or
hypopharynx. The main end points are the rate of locoregional control and the rate of
xerostomia at 2 years.
The IMRT total dose is 75 Gy (50 Gy to PTV1 and T0 + 25 Gy (10 fractions) to PTV2). The
conventional radiotherapy total dose is 70 Gy (50 Gy to PTV1 + 20 Gy (10 fractions) to
PTV2). In both arms, the cervical nodes will receive 50 Gy (65 Gy in case of Np) by
conventional radiotherapy (IMRT is allowed in the IRMT arm). In the two arms, patients will
receive concomitant cisplatin (100 mg/m² D1, D21, D42).
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Loco regional control
Jean Bourhis, PhD
Gustave Roussy, Cancer Campus, Grand Paris
France: Ministry of Health