Site for Randomized Phase II/III Trial of Surgery and Postoperative Radiation Delivered with Concurrent Cisplatin Versus Docetaxel Versus Docetaxel and Cetuximab for High-Risk Squamous Cell Cancer of the Head and Neck

Brief description of study

This study will therefore address the question whether docetaxel alone is as active as docetaxel and cetuximab combination and whether either taxane-based regimen is better than cisplatin monotherapy given to this high-risk group of patients with concurrent radiation. The less toxic weekly cisplatin regimen is selected to enhance compliance in the control arm and to parallel to weekly regimen proposed for the 2 experimental arms. If positive, this study will provide a new standard of care with a non-cisplatin regimen for patients with high-risk head and neck squamous cell carcinoma in the postop setting.


Clinical Study Identifier: s16-01709
ClinicalTrials.gov Identifier: NCT01810913
Principal Investigator: Kenneth S Hu.
Other Investigators: Joshua K Sabari, Tuyet-Phuong N Tran, Nora Russo, Thomas B. Daniels, Elaine Shum, Lindsey E Moses, Adam S Jacobson, Christoph Maier, Danny Perlaza, Marissa Rybstein, Colin Hill, Moses M Tam, Caitlin Elizabeth Ryan, Kenneth Csehak, Zujun Li, Ruth A White.


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