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Spots Global Cancer Trial Database for Cetuximab With Radiotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck in Chinese Subjects

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Trial Identification

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

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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