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Jpn J Clin Oncol. 2014 Aug;44(8):770-4. doi: 10.1093/jjco/hyu067. Epub 2014 May 19.

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).

Author information

  • 1Japan Clinical Oncology Group Data Center/Operations Office, Multi-institutional Clinical Trial Support Center, National Cancer Center, Tokyo.
  • 2Department of Medical Oncology and Hematology, Kobe University Hospital, Hyogo
  • 3Department of Head and Neck Medical Oncology, National Cancer Center Hospital East, Chiba.
  • 4Department of Radiation Oncology, Aichi Cancer Center Hospital, Aichi.
  • 5Department of Head and Neck Surgery, National Cancer Center Hospital East, Chiba.
  • 6Department of Radiation Oncology, Juntendo University, Tokyo.
  • 7Department of Otolaryngology, National Hospital Organization Tokyo Medical Center, Tokyo, Japan.


A randomized Phase II/III study was launched in Japan to evaluate the non-inferiority of concurrent chemoradiotherapy with weekly cisplatin (40 mg/m(2)) compared with concurrent chemoradiotherapy with 3-weekly cisplatin (100 mg/m(2)) 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 [].

© The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please email:


Phase II/III; clinical trials; head and neck cancer; high-risk patients; post-operative chemoradiotherapy

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