Induction Docetaxel Platinum 5-Fu (Tpf) Followed By Cetuximab-Radiotherapy (Cetux-Rt) Versus Concurrent Chemo-Radiotherapy (Ct/Rt) In Patients With N2b/C-N3 Non Operated Stage Iii-Iv Squamous Cell Cancer Of The Head And Neck (Scchn): Results Of The Gortec 2007-02 Phase Iii Randomized Trial.

6000Background: Both CT/RT, and cetux-RT have been established as standard treatments in non-operated locally advanced SCCHN. Taxotere-Platinum-5FU (TPF) is a reference induction regimen in this type of cancer and it is not known whether the addition of induction TPF followed by cetux-RT could improve the outcome of patients with locally advanced SCCHN, as compared to standard CT/RT. Methods: GORTEC 2007-02 trial was restricted to patients (pts) with palpable cervical nodes (N2b/c-N3) and was run in parallel with GORTEC 2007-01 randomized trial testing the addition of concurrent chemotherapy (CT) to cetux-RT in pts with N0-N2a disease. Selection criteria were pts fit for receiving CT with non-metastatic, non-operated stage III-IV SCC of oral cavity, oro/hypopharynx and larynx, regardless of HPV status. Pts were randomized to receive concurrent CT/RT (arm A) or induction TPF plus cetux-RT (arm B). RT was 70 Gy (2 Gy per day, 5 days per week). Concurrent CT was: 3 cycles of carboplatin 70mg/m²/d + 5FU 600mg...