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Brief Title: Cetuximab With Radiotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck in Chinese Subjects
Official Title: Open-label, Single-arm, Multicenter, Phase III Trial to Assess the Antitumor Activity and Safety of Cetuximab When Given in Combination With Radiotherapy for the Treatment of Locally Advanced Squamous Cell Carcinoma of the Head and Neck in Chinese Subjects
Study ID: NCT01012258
Brief Summary: Primary objective: to assess the antitumor activity and safety profile of cetuximab when given in combination with radiotherapy (RT) for the treatment of locally advanced squamous cell carcinoma of the head and neck (SCCHN) in Chinese subjects. Secondary objective: to assess the pharmacokinetic (PK) profile and immunogenicity of cetuximab in Chinese subjects. Further objective: to identify for cetuximab potential predictive biomarkers of response and safety.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Fujian Provincial Tumor Hospital, Fuzhou, Fujian, China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, , China
Xiangya Hospital of Central South University, Changsha, Hunan, , China
Sun Yat-sen University Cancer Center, Guangzhou, , China
Zhejiang Provincial Cancer Hospital, Hangzhou, , China
Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, , China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, , China
Zhongnan Hospital of Wuhan University, Wuhan, Hubei, , China
Name: Li Gao
Affiliation: Radiotherapy Department, Cancer Institute & Hospital, Chinese Academy of Medical Science, Beijing, China
Role: PRINCIPAL_INVESTIGATOR
Name: Junliang Cai
Affiliation: Merck Serono (Beijing) Pharmaceutical R&D Co., Ltd., an Affiliate of Merck KGaA, Darmstadt, Germany
Role: STUDY_DIRECTOR
Name: Guozhen Xu
Affiliation: Radiotherapy Department, Cancer Institute & Hospital, Chinese Academy of Medical Science, Beijing, China
Role: PRINCIPAL_INVESTIGATOR