100
Participants
Start Date
May 31, 2013
Primary Completion Date
January 28, 2021
Study Completion Date
January 13, 2022
Docetaxel
75 mg/m² on day 1 of 21-days cycle
Cisplatin
75 mg/m² on day 1 of 21-days cycle
5-fluorouracil
750 mg/m² day 1 to 5 during 24 hours of 21-days cycle
Cetuximab Induction
weekly, starting with 400 mg/m² during 120 min.(saturation) then continuing with 250 mg/m²; duration 3 cycles with 21 days
Cetuximab Radioimmunotherapy
weekly, starting with 400 mg/m² during 120 min.(saturation only arm A) then continuing with 250 mg/m²; duration 7 weeks
Boost irradiation
First 18 irradiations once daily with single dose of 1,8 Gy for 5 days per week. In addition by day 19 a second irradiation boost will be applied for further 12 days(1,5 Gy per day with at least 5 hours interval to 1,8 Gy dose. This results in total clinical target dose of 72 Gy and total subclinical target dose of 54 Gy. Duration of irradiation: 6 weeks
Hanusch Krankenhaus Wien, Vienna
PMU Salzburg, Salzburg
Landeskrankenhaus Feldkirch, Feldkirch
Landesklinikum Krems, Krems
Krankenhaus d. Barmherzigen Schwestern Linz, Linz
Kepler Universitätsklinikum, Med Campus III. Klinik für Interne 3 - Schwerpunkt Hämatologie u. Onkologie, Linz
Universität f. Strahlentherape, AKH Wien, Vienna
Klinikum Kreuzschwestern Wels GmbH, Wels
Arbeitsgemeinschaft medikamentoese Tumortherapie
OTHER