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

Inclusion Criteria: Histology and staging disease * Histologically or cytologically proven non-metastatic locally advanced HNSCC, stage III or IV, for which concomitant chemo-radiotherapy would be the standard therapy * Patients can be included either with irresectable disease or for which the concomitant chemoradiotherapy was chosen for organ preservation * Measurable disease * Primary site: oral cavity, oropharynx, hypopharynx and larynx General conditions * Written informed consent * Age \>18 years and ≤ 65 years * WHO performance status 0-1 * Adequate bone marrow function (WBC \> 3.0 x 109/L, platelets \> 100 x 109/L, Hb \> 6 mmol/L) * Adequate hepatic function: total bilirubin \< 1. 5 x upper normal limit, ASAT and ALAT \< 2.5 x upper normal limits * Adequate renal function: calculated creatinin clearance \> 60ml/min. (Cockcroft-Gault formula) Other * Expected adequacy of follow-up. Exclusion Criteria: General conditions * Active alcohol addiction * Admission for COPD in the last 12 months * Weight loss \> 10% in 3 months before entry * Pregnancy or lactation * Patients (M/F) with reproductive potential not implementing adequate contraceptives measures Prior or current history * Prior surgery, radiotherapy or chemotherapy for this tumor * Serious concomitant diseases preventing the safe administration of chemotherapy and/or radiotherapy or likely to interfere with the study assessments * Serious active infections * Other malignancies in the past 5 years with the exception of adequately treated carcinoma in situ of the cervix, or squamous or basal cell carcinoma of the skin Concomitant treatments * Concomitant (or within 4 weeks before randomisation) administration of any other experimental drug under investigation * Concurrent treatment with any other anti-cancer therapy