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

  • STATUS
    Recruiting
  • participants needed
    70
  • sponsor
    Radboud University
Updated on 7 November 2020
measurable disease
fluorouracil
dental caries
chemoradiotherapy
docetaxel
squamous cell carcinoma of head and neck
immunomodulator

Summary

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.

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

Details
Condition head and neck cancer
Treatment conventional radiotherapy with 'high' dose cisplatin, accelerated radiotherapy with 'low' dose cisplatin
Clinical Study IdentifierNCT00774319
SponsorRadboud University
Last Modified on7 November 2020

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