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Futoshi Kunieda, Naomi Kiyota, Makoto Tahara, Takeshi Kodaira, Ryuichi Hayashi, Satoshi Ishikura, Junki Mizusawa, Kenichi Nakamura, Haruhiko Fukuda, Masato Fujii, Head and Neck Cancer Study Group of the Japan Clinical Oncology Group, Randomized Phase II/III Trial of Post-operative Chemoradiotherapy Comparing 3-Weekly Cisplatin with Weekly Cisplatin in High-risk Patients with Squamous Cell Carcinoma of Head and Neck: Japan Clinical Oncology Group Study (JCOG1008), Japanese Journal of Clinical Oncology, Volume 44, Issue 8, August 2014, Pages 770–774, https://doi.org/10.1093/jjco/hyu067
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Abstract
A randomized Phase II/III study was launched in Japan to evaluate the non-inferiority of concurrent chemoradiotherapy with weekly cisplatin (40 mg/m2) compared with concurrent chemoradiotherapy with 3-weekly cisplatin (100 mg/m2) for post-operative high-risk patients with locally advanced squamous cell carcinoma of head and neck. This study began in October 2012, and a total of 260 patients will be accrued from 18 institutions within 5 years. The primary endpoint of the Phase II part is proportion of treatment completion and that of the Phase III part is overall survival. The secondary endpoints are relapse-free survival, local relapse-free survival, nutrition-support-free survival, non-hospitalized treatment period during permissible treatment period and adverse events. This trial was registered at the UMIN Clinical Trials Registry as UMIN 000009125 [http://www.umin.ac.jp/ctr/].