Journal
JAPANESE JOURNAL OF CLINICAL ONCOLOGY
Volume 44, Issue 8, Pages 770-774Publisher
OXFORD UNIV PRESS
DOI: 10.1093/jjco/hyu067
Keywords
head and neck cancer; post-operative chemoradiotherapy; high-risk patients; clinical trials; Phase II/III
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Funding
- National Cancer Center Research and Development Funds [23-A-16, 23-A-21]
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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 [http://www.umin.ac.jp/ctr/].
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