Postoperative Bio-Chemoradiotherapy Using Cetuximab and Docetaxel in Patients With Cis-Platinum–Intolerant Core High-Risk Head and Neck Cancer: Protocol of a Phase 2 Nonrandomized Clinical Trial

Goshi Nishimura, Hiromitsu Hatakeyama, Osamu Shiono, Masataka Taguri, Masanori Komatsu, Daisuke Sano, Naoko Sakuma, Kenichiro Yabuki, Yasuhiro Arai, Kunihiko Shibata, Yoshihiro Chiba, Teruhiko Tanabe (+1 others)
2018 JMIR Research Protocols  
We confirmed the safety of postoperative bio-chemoradiotherapy using cetuximab and docetaxel in a small number of patients with cis-platinum-intolerant core high-risk head and neck cancer. Objective: To assess treatment efficacy, we planned a phase 2 study of postoperative bio-chemoradiotherapy for patients with cis-platinum-intolerant core high-risk head and neck cancer and will compare the results to those of previously collected radiotherapy data. Methods: Patients who underwent definitive
more » ... rgery for oral cavity, laryngeal, oropharyngeal, or hypopharyngeal advanced cancer, whose postoperative pathological results indicated core high risk for recurrence (eg, positive margin in the primary site or extranodal extension) and who were cis-platinum-intolerant, will undergo postoperative bio-chemoradiotherapy. The primary end point is 2-year disease-free survival. Results: The expected 2-year disease-free survival is set at 55%, and the calculated sample size is 35 patients, according to a statistical analysis based on previous reports. Conclusions: This treatment method is expected to improve the survival rate of patients with severe head and neck cancer.
doi:10.2196/11003 pmid:30139721 fatcat:ovjjlvbpjrbyxgwzcveqoal5hu