Last updated on April 2012

TPF Induction With Concomitant Chemoradiation to Treat Patients With Head and Neck Cancer

Brief description of study

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.

Detailed Study Description

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

Clinical Study Identifier: NCT00774319

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