480
Participants
Start Date
October 31, 2009
Primary Completion Date
May 31, 2016
Study Completion Date
August 31, 2016
Nimotuzumab
"Nimotuzumab:(200mg/w,weekly, 7-8 weeks, one week before radiotherapy)~Radiotherapy:~IMRT: Nasopharynx: GTV 66-78. 2Gy,CTV1 60-64Gy,CTV2 54-60Gy.30-34 times, 2.20-2.30Gy/time,once a day, 5 days/w, 6-7 weeks. Neck: lymph node positive, GTVn 60-70Gy, once a day, 5 days/w, 6-7weeks; lymph node negative, CTVn50-55Gy, once a day, 5 days/w, 6-7 weeks.~CRT: Nasopharynx, 70-(76-80)Gy, 35-(38-40)times, 2Gy/time, once a day, 5 days/w, 6-8weeks. If disease residual when radiotherapy finished could increase the dose appropriate. Neck: lymph node positive, 64-70 Gy, 32-35 times, 2 Gy/time, once a day, 5 days/w, 6-7 weeks; lymph node negative, 50-56 Gy, 25-28 times,2 Gy/time, once a day, 5 days/w, 5-6weeks cisplatin~Chemotherapy:~Cisplatin (100 mg/m2,1 time/21d, 3 times，on days 2, 23, 44 during the radiotherapy)"
placebo plus chemoradiotherapy
"Placebo treatment:4 bottles/w,weekly, 7-8 weeks, one week before radiotherapy~Radiotherapy:~IMRT: Nasopharynx: GTV 66-78. 2Gy,CTV1 60-64Gy,CTV2 54-60Gy.30-34 times, 2.20-2.30Gy/time,once a day, 5 days/w, 6-7 weeks. Neck: lymph node positive, GTVn 60-70Gy, once a day, 5 days/w, 6-7weeks; lymph node negative, CTVn50-55Gy, once a day, 5 days/w, 6-7 weeks.~CRT: Nasopharynx, 70-(76-80)Gy, 35-(38-40)times, 2Gy/time, once a day, 5 days/w, 6-8weeks. If disease residual when radiotherapy finished could increase the dose appropriate. Neck: lymph node positive, 64-70 Gy, 32-35 times, 2 Gy/time, once a day, 5 days/w, 6-7 weeks; lymph node negative, 50-56 Gy, 25-28 times,2 Gy/time, once a day, 5 days/w, 5-6weeks cisplatin~Chemotherapy: Cisplatin (100 mg/m2,1 time/21d, 3 times，on days 2, 23, 44 during the radiotherapy)"
Cancer Institute & Hospital.Chinese Academy of Medical Sciences, Beijing
Peking Union Medical College Hospital, Beijing
Beijing Cancer Hospital, Beijing
The General Hospital of the People's Liberation Army, Beijing
Shengjing Hospital of China Medical University, Shenyang
Liaoning Province Cancer Hospital, Shenyang
The Affiliated Cancer Hospital of Haerbin Medical University, Haerbin
The Affiliated Renji Hosptial of ShanghaiJiao Tong University, Shanghai
Shandong Caner Hospital, Jinan
Tianjin Cancer Hospital, Tianjin
Zhejiang Cancer Hospital, Hangzhou
Fujian Medical University Union Hospital, Fuzhou
Xiamen First Hospital, Xiamen
Hubei Province Caner Hospital, Wuhan
Henan Cancer Hospital, Zhengzhou
The Affiliated Cancer Hospital of Guangzhou Medical Hospital, Guangzhou
Affiliated Tumor Hospital of Guangxi Medical University, Xining Shequ
Fujian Provincial Cancer Hospital, Fuzhou
The First Affiliated Hospital of Guangxi Medical University, Nanning
Wuhan Union Hospital, Wuhan
Sichuan Province Cancer Hospital, Chengdu
West China School of Medicine/West China Hospital of Sichuan University (WCSM/WCH), Chengdu
Fudan University Shanghai Cancer Center, Shanghai
The Fourth Hebei Province Hospital, Shijiazhuang
Lead Sponsor
Biotech Pharmaceutical Co., Ltd.
OTHER