Carcinomas of sinuses and salivary glands are rare and heterogeneous in terms of anatomical sites and histology subtypes. For these reasons and because of the absence of prospective study results, their treatment is still largely extrapolated from data of frequent carcinomas of the upper digestive tract. Treatment is based on surgery and radiotherapy (proof level grade C). Despite the advances, the 5-year overall survival does not exceed 65%, mainly due to locoregional recurrence. In this context, chemotherapy administered concomitantly with radiotherapy could increase the efficacy of locoregional treatment by radiosensitization, regardless of the histology.
The GORTEC launched a multicenter, phase III randomized, open-label, study evaluating in case of high-risk of locoregional relapse, the impact of the addition after surgery of cisplatin 100 mg/m2 (every 3 weeks; 3 cycles) to radiotherapy. The population is defined as patients with radioresistant histologies (e.g. cystic adenoids carcinomas) or patients with unfavorable histoprognostic critera (e.g. incomplete resection, T4 tumor, malignant lymph node(s) with capsular rupture, presence of emboli, …). The primary endpoint is the progression free survival. Secondary outcomes are: overall survival, quality of life, time to progression (locoregional and distant) and toxicities. Two hundred and sixty patients will be enrolled in 5 years. Eligible patients are adults, with a performance status ≤ 2 and an adequate hematological and renal function for cisplatin treatment. Recruitment is ongoing in France. The study comprises a quality insurance program in radiotherapy and surgery. Coordinating investigators are Drs Ferrand and Thariat.
Clinical trial identification
Legal entity responsible for the study
GORTEC (Groupe Oncologie Radiothérapie Tête et Cou)
All authors have declared no conflicts of interest.