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Brief Title: Efficacy of HIPEC in the Treatment of Advanced-Stage Epithelial Ovarian Cancer After Cytoreductive Surgery
Official Title: A Phase III Multicenter Prospective Randomized Controlled Clinical Trial of Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Advanced-Stage Epithelial Ovarian Cancer After Cytoreductive Surgery
Study ID: NCT03373058
Brief Summary: This project is a multi-center, prospective, randomized controlled clinical observation the safety and efficacy of hyperthermic intraperitoneal chemotherapy in the treatment of advanced-stage epithelial ovarian cancer after cytoreductive surgery. Median recurrence-free survival is the primary end points of this project.
Detailed Description: The current standard treatment for epithelial ovarian cancer, tubal cancer, and primary peritoneal cancer is maximal cytoreductive surgery followed by intravenous chemotherapy with or without intraperitoneal chemotherapy (IP). Recently, the organizations of SGO and ASCO recommended that women with Fagotti score by laparoscopic exploration \< 6 would benefit from primary cytoreductive surgery followed by postoperative chemotherapy, and are likely to attain optimal cytoreduction (residual lesion ≤ 1 cm). Hyperthermia promotes chemotherapy to penetrate deeper into the cancer tissue. Therefore, hyperthermic intraperitoneal chemotherapy (HIPEC) as newly postoperative chemotherapy after primary cytoreductive surgery in the treatment of ovarian cancer could lead to higher response rate and better survival outcomes.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Affiliated Tumor Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital,Sun Yat-sen University, Guanzhou, Guangdong, China
Beijing Cancer Hospital, Beijing, , China
Chongqing Cancer Hospital, Chongqing, , China
The First Affiliated Hospital of Chongqing Medical University, Chongqing, , China
Hubei General Hospital, Wuhan, , China
Henan Cancer Hospital, Zhengzhou, , China
Name: Shuzhong Cui, M.D
Affiliation: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Role: STUDY_DIRECTOR
Name: Zhongqiu Lin, M.D
Affiliation: Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Role: STUDY_DIRECTOR