Clinical Trial Details


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A randomized phase III multicenter trial of neoadjuvant docetaxel (Taxotere) plus cisplatin plus 5-fluorouracil versus neoadjuvant cisplatin plus 5-fluorouracil in patients with locally advanced inoperable squamous cell carcinoma of the head and neck

Study documentation

Trial Status LT-FU ongoing
Dates Date of activation: 13-Apr-1999
Date Step1 close: 15-Mar-2002
Data management at EORTC Yes
Design Phase 3
Randomized open label
Targeted Sample size EORTC Groups: 348
Treatment Radiotherapy, Drug
Study Staff Catherine Fortpied (Statistician) , EORTC Headquarters, Brussels
Type of cancer Head and Neck
Participating groups EORTC Head and Neck Cancer Group
Centers to be activated Athens University - Attikon University General Hospital (Athens, Greece)
CHU de Nimes - Hopital Caremeau (Nimes, France)
Hospital General De Jerez (Jerez, Spain)
IRCCS - Istituto Nazionale dei Tumori (Milano, Italy)
Institut Jules Bordet-Hopital Universitaire ULB (Brussels, Belgium)
Institut du Cancer de Montpellier (Montpellier, France)
Medical University of Graz (Graz, Austria)
Radboud University Medical Center Nijmegen (Nijmegen, Netherlands)
Universitair Ziekenhuis Antwerpen (Edegem, Belgium)
Wiener Gesundheidsverbund - Klinik Favoriten (Vienna, Austria)
Protocol summary
NCT number NCT00003888
Financial Support Academic Fund