Spots Global Cancer Trial Database for Nimotuzumab in Combination With Chemoradiation for Nasopharyngeal Cancer
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Trial Identification
Brief Title: Nimotuzumab in Combination With Chemoradiation for Nasopharyngeal Cancer
Official Title: A Prospective,Randomized,Double-Blind,Controlled,Multicenter,Phase III Study of Nimotuzumab in Combination With Chemotherapy and Radiotherapy for Patients With Local Advanced Nasopharyngeal Cancer
Study ID: NCT01074021
Conditions
Study Description
Brief Summary: Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical trials are ongoing globally to evaluate nimotuzumab in different indications. Nimotuzumab has been granted approval for use in squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal cancer in different countries. The Clinical efficacy has been shown in adult with head and neck cancer. The study assessed the clinical efficacy, and safety of the combination of Nimotuzumab administered concomitantly with chemotherapy and radiotherapy in patients with advanced nasopharyngeal cancer.
Detailed Description: Patients with advanced nasopharyngeal cancer will be randomized to 2 arms. The patients in experimental arm will be treated with Nimotuzumab which will be used concurrently with radiotherapy and chemotherapy. The chemotherapy regimen were Cisplatin monotherapy. The active comparator arm will be administered chemotherapy and radiotherapy only. The dose and regimen were the same with experiment arm. The patients'hematopoietic , hepatic and renal function tests will be monitored weekly, a physical exam and reassessment of the tumor will be performed at the first and the fourth month, and followup every six months to evaluate the survival index in three years after the study.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Fujian Medical University Union Hospital, Fuzhou, Fujian, China
Fujian Provincial Cancer Hospital, Fuzhou, Fujian, China
Xiamen First Hospital, Xiamen, Fujian, China
The Affiliated Cancer Hospital of Guangzhou Medical Hospital, Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China
Affiliated Tumor Hospital of Guangxi Medical University, Xining, Guangxi, China
The Fourth Hebei Province Hospital, Shijiazhuang, Hebei, China
The Affiliated Cancer Hospital of Haerbin Medical University, Haerbin, Heilongjiang, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Hubei Province Caner Hospital, Wuhan, Hubei, China
Wuhan Union Hospital, Wuhan, Hubei, China
Shengjing Hospital of China Medical University, Shenyang, Liaoning, China
Liaoning Province Cancer Hospital, Shenyang, Liaoning, China
Shandong Caner Hospital, Jinan, Shandong, China
Sichuan Province Cancer Hospital, Chengdu, Sichuan, China
West China School of Medicine/West China Hospital of Sichuan University (WCSM/WCH), Chengdu, Sichuan, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Cancer Institute & Hospital.Chinese Academy of Medical Sciences, Beijing, , China
Peking Union Medical College Hospital, Beijing, , China
Beijing Cancer Hospital, Beijing, , China
The General Hospital of the People's Liberation Army, Beijing, , China
The Affiliated Renji Hosptial of ShanghaiJiao Tong University, Shanghai, , China
Fudan University Shanghai Cancer Center, ShangHai, , China
Tianjin Cancer Hospital, Tianjin, , China
Contact Details
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