A randomized phase III trial (RTOG 0522) of concurrent accelerated radiation plus cisplatin with or without cetuximab for stage III-IV head and neck squamous cell carcinomas (HNC).

5500 Background: The concurrent use of cisplatin (CDDP) or cetuximab (CET) with radiation (RT) has been shown to improve survival of patients with stage III-IV HNC. Since CET enhances the response of metastatic HNC to platinum-containing regimens and survival, the RTOG launched a phase III trial to test the hypothesis that adding CET to the RT-CDDP platform for frontline therapy of stage III-IV HNC improves progression free survival. Methods: Patients with stage III-IV carcinoma of the oropharynx, larynx, and hypopharynx, having Zubrod performance of 0-1, and meeting predefined blood chemistry criteria were enrolled after providing consent. The experimental regimen (Arm A) consisted of a loading dose and 6-7 weekly doses of CET given in conjunction with the control arm (B) of 70-72 Gy (6 weeks) + 2 cycles of CDDP (q3 weeks). Results: From 11/’05 to 3/’09, 940 patients were enrolled. Of the 895 evaluable patients, 447 randomized to Arm A and 448 to Arm B. Over 90% of patients received 2 CDDP cycles in both...