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Brief Title: A Trial to Compare Oxaliplatin, Folinic Acid (FA) and 5-Fluorouracil (5FU) Combination Chemotherapy (FOLFOX-4) With or Without Cetuximab in the 1st Line Treatment of Metastatic Colorectal Cancer (mCRC) in Chinese Rat Sarcoma Viral Oncogene Homolog (RAS) Wild-type Patients
Official Title: An Open-label, Randomized, Controlled, Multicenter Phase III Trial to Compare Cetuximab in Combination With FOLFOX-4 Versus FOLFOX-4 Alone in the First Line Treatment of Metastatic Colorectal Cancer in Chinese Subjects With RAS Wild-type Status
Study ID: NCT01228734
Brief Summary: The purpose of this study was to assess whether the progression free survival (PFS) time with FOLFOX-4 plus cetuximab is longer than that with FOLFOX-4 alone as first-line treatment for mCRC in Chinese subjects with RAS wild-type tumors.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Fujian Province Cancer Hospital, Fuzhou, Fujian, China
Fuzhou General Hospital, Fuzhou, Fujian, China
First Hospital Affiliated to Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China
Nanfang Hospital, Guangzhou, Guangdong, China
The Tumor Hospital of Harbin Medical University, Harbin, Heilongjiang, China
Union Hospital of Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China
Jilin Cancer Hospital, Changchun, Jilin, China
First Affiliated Hospital of Jilin University, Changchun, Jilin, China
The Affiliated Hospital of Medical College Qingdao University, Qingdao, Shandong, China
The First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China
307 Hospital of PLA, Beijing, , China
The General Hospital of the People's Liberation Army, Beijing, , China
Affiliated Hospital of Bengbu Medical College, Bengbu, , China
The Xiangya 2nd Hospital of Central South University, Changsha, Hunan, , China
Southwest Hospital, Chongqing, , China
Yunnan Provincial Tumor Hospital, KunMing, Yunnan, , China
The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, , China
Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, , China
Fudan University Shanghai Cancer Center, Shanghai, , China
Shanghai First People's Hospital, Shanghai, , China
Fudan University Zhongshan Hospital, Shanghai, , China
The First Affiliated Hospital of Soochow University, Shuzhou, Jiangsu, , China
Tianjin People's Hospital, Tianjin, , China
Xijing Hospital the 4th Military Medical University of PLA, Xi'an, , China
Name: Medical Responsible
Affiliation: Merck Serono Co., Ltd., Beijing, an affiliate of Merck KGaA, Darmstadt, Germany
Role: STUDY_DIRECTOR