The purpose of this trial is to compare two different treatments for fit patients with head and neck cancer: All patients are given induction-chemotherapy (docetaxel, cisplatin, 5-FU). Subsequently patients are being randomised into two groups: - The first group receives neo-adjuvant chemotherapy ('high' dose cisplatin) and conventional radiotherapy - The second group receives neo-adjuvant chemotherapy ('low' dose cisplatin) and accelerated radiotherapy.
Induction Chemotherapy TPF(arm A and B) : Docetaxel 75 mg/m2 iv on day 1, Cisplatin 75 mg/ m2 iv on day 1, 5-FU 750 mg/ m2/day iv continuous infusion (in Hickman or port a cath) on days 1-5; prophylactic G-CSF This cycle will be repeated every 21 days for a maximum of 4 cycles. Clinical evaluation after each cycle and radiological evaluation after 2 cycles will take place. In case of PD or SD (after 2 cycles) with no minor response (no decrease in measurable disease from baseline) concomitant chemoradiotherapy will started per protocol. Surgery The investigators in each centre can decide neck surgery for residual tumor
| Condition | Head and Neck Cancer |
|---|---|
| Treatment | conventional radiotherapy with 'high' dose cisplatin, accelerated radiotherapy with 'low' dose cisplatin |
| Clinical Study Identifier | NCT00774319 |
| Sponsor | Radboud University |
| Last Modified on | 22 January 2022 |
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