Comparison of Standard to Split-Dose TPF Induction Chemotherapy followed by Bio-radiation for LASCC of the Head and Neck: Results of the ICRAT randomized Phase II Study.

e17042 Background: TPF induction chemotherapy (IC) is a reasonable treatment option for locally advanced (LA) squamous cell carcinoma (SCC) of the head and neck (HN). However, substantial toxicity may compromise compliance and thereby also treatment efficacy. ICRAT is a randomized 3-arm phase 2 trial evaluating efficacy and safety of two TPF-IC regimens followed by bio-radiation (BRT) vs. concurrent PF chemoradiation (CRT) for chemo-/radiation-naive LASCCHN. Methods: Stage IV oro-/hypopharynx/oral cavity LASCC were randomly assigned to either 3 cycles of standard TPF-IC (arm A) with TP (75 mg/m2, each day 1) and F (750 mg/m2/24h days 1-4) or split-course TPF-IC (arm B) with TP (40 mg/m2, each days 1 and 8) and F (1500 mg/m2/24h days 1 and 8) vs. PF-CRT alone (arm C). Progression after first cycle of TPF-IC in arm A or B led to cross over to BRT with 72 Gy. Responders (complete: CR; partial: PR) and stable disease patients received 3 cycles of TPF-IC followed by weekly cetuximab (250 mg/m2, initial loading...