Randomized phase III trial of induction chemotherapy (ICT) with docetaxel-cisplatin-5fluorouracil (DCF) followed by cisplatin-radiotherapy (CRT) or cetuximab-radiotherapy (CetRT) in patients (pts) with locally advanced unresectable head and neck cancer (LAUHNC).

6001Background: CetRT has not been compared with CRT after ICT in phase III. Objective: To compare the impact on overall survival of CRT vs. CetRT after ICT in a Phase III randomized controlled clinical trial with a non-inferiority design of CetRT compared to CRT. Response Rate (RR), loco-regional control (LRC) and toxicity in both arms were considered secondary objectives. Methods: Pts with LAUHNC, ECOG 0-1, 18-72 years old, measurable disease, and with adequate renal and liver function, received standard DCF with G-CSF. After at least 2 cycles (range 2-3), pts with objective response or stable disease were randomized (stratified by tumor location, 1:1) between cisplatin 100 mg/m2 days 1, 22, 43) plus radiotherapy (dose 68-72 Gy, in 35 fractions) (arm A) or cetuximab (400mg d1, 250mg/m2 weekly concurrent with RT) plus the same radiotherapy scheme (arm B). Non-inferiority will be assumed if the upper limit of the one-sided 95% CI of the hazard ratio for OS (CetRT/CRT) is below 1.3. Analyses were done by i...