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Brief Title: A Study of the Efficacy and Safety of Bevacizumab in Chinese Women With Newly Diagnosed, Previously Untreated Stage III or Stage IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Official Title: A Phase III Trial of Carboplatin and Paclitaxel Plus Placebo Versus Carboplatin Paclitaxel Plus Concurrent and Extended Bevacizumab in Chinese Women With Newly Diagnosed, Previously Untreated, Stage III or Stage IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Study ID: NCT03635489
Brief Summary: This multicenter, double-blind, 2-arm, randomized study will evaluate the efficacy and safety of bevacizumab plus paclitaxel and caboplatin compared with placebo plus paclitaxel and caboplatin in Chinese participants with newly diagnosed, previously untreated Stage III or Stage IV epithelial ovarian, fallopian tube, or primary peritoneal cancer. Participants whose disease has not progressed after six cycles of paclitaxel and carboplatin with either bevacizumab or placebo will continue treatment with either bevacizumab or placebo until disease progression, unacceptable toxicity, or a maximum of 22 cycles, whichever occurs first.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing City, , China
the First Hospital of Jilin University, Changchun, , China
Jilin Cancer Hospital, Changchun, , China
Xiangya Hospital Central South University, Changsha City, , China
West China Second University Hospital, Chengdu City, , China
Fujian Cancer Hospital, Fuzhou, , China
Sun Yet-sen University Cancer Center, Guangzhou City, , China
Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department, Hangzhou City, , China
Harbin Medical University Cancer Hospital, Harbin, , China
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, Nanjing City, , China
Guangxi Cancer Hospital of Guangxi Medical University, Nanning, , China
Nantong Tumor Hospital, Nantong City, , China
Fudan University Shanghai Cancer Center, Shanghai City, , China
Tianjin Medical University General Hospital, Tianjin, , China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University, Xi'an, , China
Henan Cancer Hospital, Zhengzhou, , China
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR