144
Participants
Start Date
September 30, 2010
Primary Completion Date
October 31, 2015
Study Completion Date
January 31, 2016
Nimotuzumab
200mg (4 bottles), once a week for 7 weeks during irradiation (week 1, week 2, week 3, week 4, week 5, week 6 and week 7). After irradiation 200mg (4 bottles), once every 4 weeks for 2 cycles (week 9 and week 13)
Placebo
4 bottles placebo, once a week for 7 weeks during irradiation (week 1, week 2, week 3, week 4, week 5, week 6 and week 7). After irradiation 200mg (4 bottles), once every 4 weeks for 2 cycles (week 9 and week 13)
cisplatin
cisplatin 25 mg/m2/d, d1-3, once every 4 weeks for 4 cycles (week 1, week 5, week 9 and week 13); 5-FU 600 mg/m2/d, d1-3, continuously infusion for 72 hrs,once every 4 weeks for 4 cycles (week 1, week 5, week 9 and week 13).
Radiotherapy
"A total dose of 61.2 Gy will be delivered in 34 fractions at 1.8 Gy/fraction, 5 fractions per week in 6.8 weeks.~Placebo: 4 bottles placebo, once a week for 7 weeks during irradiation (week 1, week 2, week 3, week 4, week 5, week 6 and week 7). After irradiation 200mg (4 bottles), once every 4 weeks for 2 cycles (week 9 and week 13)"
Fudan University Shanghai Cancer Center, Shanghai
Shanghai Chest Hospital, Shanghai
Shanghai First People's Hospital, Shanghai
Cancer Hospital of Jiangsu Province, Nanjing
The First Affiliated Hospital of Soochow University,Suzhou First People's Hospital, Suzhou
Northern Jiangsu People's Hospital, Yangzhou
Chinese Academy of Medical Sciences Cancer Hospital, Beijing
Affiliated Hospital of Qingdao University Medical College, Qingdao
Tianjin Cancer Hospital, Tianjin
Zhejiang Cancer Hospital, Hangzhou
The First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou
Fujian Provincial Tumor Hospital, Fuzhou
Huazhong University of Science and Technology, Union Hospital, Tongji Medical College, Wuhan
First Affiliated Hospital of Zhengzhou University, Zhengzhou
Cancer Center of Sun Yat-sen, Guangzhou
Fourth Military Medical University Xijing Hospital, Xian
The first bethune hospital of Jilin university, Changchun
Lead Sponsor
Biotech Pharmaceutical Co., Ltd.
OTHER