This multicentre, randomised Phase II Pilot Study evaluates the efficacy of docetaxel, cisplatin and 5-fluorouracil or Cetuximab, followed by Cetuximab with radiotherapy.
It will be evaluated whether 5-FU can be replaced by immunotherapy with cetuximab within a taxane/cisplatin-containing induction-chemotherapy scheme for advanced carcinoma of the head and neck. As 5-FU causes severe mucosal toxicities which are added to known toxicities of cisplatin, a combination-therapy with reduced toxicities and same efficacy would be a acceptable alternative to patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
75 mg/m² on day 1 of 21-days cycle
75 mg/m² on day 1 of 21-days cycle
750 mg/m² day 1 to 5 during 24 hours of 21-days cycle
weekly, starting with 400 mg/m² during 120 min.(saturation) then continuing with 250 mg/m²; duration 3 cycles with 21 days
weekly, starting with 400 mg/m² during 120 min.(saturation only arm A) then continuing with 250 mg/m²; duration 7 weeks
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
Landeskrankenhaus Feldkirch
Feldkirch, Austria
Landesklinikum Krems
Krems, Austria
Krankenhaus d. Barmherzigen Schwestern Linz
Linz, Austria
Kepler Universitätsklinikum, Med Campus III. Klinik für Interne 3 - Schwerpunkt Hämatologie u. Onkologie
Linz, Austria
PMU Salzburg
Salzburg, Austria
Hanusch Krankenhaus Wien
Vienna, Austria
Universität f. Strahlentherape, AKH Wien
Vienna, Austria
Klinikum Kreuzschwestern Wels GmbH
Wels, Austria
Response Rate (CR, PR)
RECIST criteria
Time frame: 3 months after end of therapy
Overall Response Rate (CR, PR, PD, SD)
RECIST
Time frame: until 3 months after therapy
Locoregionally monitoring
Time frame: after one year
Progression Free Survival (PFS)
Time frame: 1, 2 and 5 years after start of therapy
Adverse reactions
Information about acute toxicity (grade, relation to study drug) during study treatment and until 3 months after end of radiotherapy will be collected for each patient using CTCAE 3.0 criteria list. Information about late toxicity (grade) will be collected after 3 months of radiotherapy and until 60 months after radiotherapy using RTOG/EORTC toxicity criteria. Kind and number of toxicities will be described according to grade. The highest grade of each patient and toxicity will be analysed.
Time frame: During treatment and until 60 months after end of radiotherapy
Overall-Survival
Time frame: 1, 2 and 5 years after start of therapy
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