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).
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/].
Japan Clinical Oncology Group Data Center/Operations Office, Multi-institutional Clinical Trial Support Center, National Cancer Center, Tokyo.
Futoshi
F
Kunieda
Department of Medical Oncology and Hematology, Kobe University Hospital, Hyogo nkiyota@med.kobe-u.ac.jp.
Naomi
N
Kiyota
Department of Head and Neck Medical Oncology, National Cancer Center Hospital East, Chiba.
Makoto
M
Tahara
Department of Radiation Oncology, Aichi Cancer Center Hospital, Aichi.
Takeshi
T
Kodaira
Department of Head and Neck Surgery, National Cancer Center Hospital East, Chiba.
Ryuichi
R
Hayashi
Department of Radiation Oncology, Juntendo University, Tokyo.
Satoshi
S
Ishikura
Japan Clinical Oncology Group Data Center/Operations Office, Multi-institutional Clinical Trial Support Center, National Cancer Center, Tokyo.
Junki
J
Mizusawa
Japan Clinical Oncology Group Data Center/Operations Office, Multi-institutional Clinical Trial Support Center, National Cancer Center, Tokyo.
Kenichi
K
Nakamura
Japan Clinical Oncology Group Data Center/Operations Office, Multi-institutional Clinical Trial Support Center, National Cancer Center, Tokyo.
Haruhiko
H
Fukuda
Department of Otolaryngology, National Hospital Organization Tokyo Medical Center, Tokyo, Japan.
Masato
M
Fujii
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy; D002945:Cisplatin / Q000008:administration & dosage*; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy; D006801:Humans; D007564:Japan; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D011184:Postoperative Period; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D002945:Cisplatin
Phase II/III; clinical trials; head and neck cancer; high-risk patients; post-operative chemoradiotherapy