SGCs are rare and heterogenous tumors (
In this multicenter, randomized, phase II intergroup study a total of 76 treatment naïve patients (Cohort A) are planned to be randomized to receive ADT or platinum-based chemotherapy. Previously treated patients will be enrolled in a separate Cohort B to receive ADT. Patients from Cohort A randomized to chemotherapy can also enter Cohort B at disease progression. The primary endpoint is PFS for Cohort A and best overall response for Cohort B. Central testing of AR expression is based on staining intensity (0 = negative to 3 = strong) and percentage of positive nuclear stained cells (0 = ≤10% to 3 = ≥70%). AR overexpression requires a maximum score of 3 on both scales. Mechanisms of AR activation and resistance will be studied. This study is led by EORTC Head and Neck Cancer Group with UNICANCER/REFCOR, International Rare Cancer Initiative UK Salivary Gland Cancer Group and RARECARENet. It will run in 35 sites in 10 countries: Austria, Belgium, France, Germany, Greece, Hungary, Italy, Portugal, The Netherlands, and United Kingdom. Sites from the EURACAN European Reference Network are participating. Currently, 36 patients are registered; 20 have AR overexpression, of which 16 have been randomized in Cohort A. Identification of AR as a treatment target in SGC can be practice changing.
Clinical trial identification
EORTC 1206 HNCG http://clinicaltrials.gov/ct/show/NCT01969578
Legal entity responsible for the study
European Organization for Research and Treatment of Cancer
EORTC ICR RARECAREnet Fondazione IRCCS Istituto Nazionale dei Tumori
All authors have declared no conflicts of interest.