The purpose of the trial is to determine the feasibility of an induction chemotherapy with radio-immunotherapy in patients with head and neck cancer stage III/IV
3 Cycles of: Docetaxel 75 mg/m2 on d1, Cisplatin 75 mg/m2 on d1, 5-FU 750 mg/m2 on days 1-5 as continuous i.v. infusion, Duration of 1 cycle: 21 days; Followed by Cetuximab 400 mg/m2, Start of radiotherapy: 1 week after the first application of Cetuximab, During radiotherapy (35 x 2 Gy): Cetuximab 250 mg/m2 weekly, Up to 8 applications of Cetuximab.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
51
75mg/m² day 1
75mg/m² day 1
750mg/m²/day day 1-5
LKH Feldkirch, Dept. of Radiooncology
Feldkirch, Austria
Medical University of Graz, Dept. of Radiooncology
Graz, Austria
LKH Leoben Dept. of Hemato-Oncology
Leoben, Austria
UK Salzburg, LKH: Universitätsklinik für Innere Medizin III
Salzburg, Austria
Locoregional tumour control
Time without progression of locoregional disease, locoregional recurrence of disease or death from any cause after one year.
Time frame: 12 months
Response rate
PET-CT or CT, RECIST criteria
Time frame: 24 months
Progression free survival
PFS is calculated from start of therapy until disease progression or death from any cause.
Time frame: 24 months
Overall survival
OS is calculated from start of therapy to death from any cause.
Time frame: 24 months
Toxicities
The highest grade of a toxicity per patient is included in the analysis
Time frame: 24 months
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standard fraction up to a total dose of 70Gy/35 fractions/7weeks or accelerated regimen, up to a total dose of 72Gy/42 fractions over 6 weeks
250mg/m²/week after an initial loading dose of 400mg/m²
Medical University of Vienna, Dept. of Medicine I
Vienna, Austria