 Patients who meet inclusion and exclusion criteria will be randomized to one of two study treatments. Patient assignment to treatment is performed based on the randomization list, and by allocating the first and lowest randomization code available. The randomization list will be generated by the Pharmacy - Investigational Drug Service - of the coordinating center and the relevant part thereof will be sent to the investigational sites The information relating to the randomization list are is strictly confidential and may be accessed only by authorized persons and the data concerning the study will be entered into the database at the time of the follow-up visits. An interim assessment of global survival is foreseen to occur once 50 of patients and the data relating to their first follow-up visit have been included into the database. 