Spots Global Cancer Trial Database for Efficacy of HIPEC as NACT and Postoperative Chemotherapy in the Treatment of Advanced-Stage Epithelial Ovarian Cancer
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Trial Identification
Brief Title: Efficacy of HIPEC as NACT and Postoperative Chemotherapy in the Treatment of Advanced-Stage Epithelial Ovarian Cancer
Official Title: A Phase III Multicenter Prospective Randomized Controlled Clinical Trial of HIPEC as NACT and Postoperative Chemotherapy After Interval Debulking Surgery in the Treatment of Advanced-Stage Epithelial Ovarian Cancer
Study ID: NCT03180177
Study Description
Brief Summary: This project is a multi-center, prospective, randomized controlled clinical observation the safety and efficacy of hyperthermic intraperitoneal chemotherapy as neoadjuvant chemotherapy(NACT) and postoperative chemotherapy after interval debulking surgery (IDS) for advanced-stage epithelial ovarian cancer . PR/SD rate, percentage of optimal debulking surgery and 3-year disease-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 a high perioperative risk profile or a low likelihood of achieving cytoreduction to \< 1 cm of residual disease (ideally to novisible disease) should receive neoadjuvant chemotherapy. Hyperthermia promotes chemotherapy to penetrate deeper into the cancer tissue. Therefore, hyperthermic intraperitoneal chemotherapy (HIPEC) as neoadjuvant chemotherapy and postoperative chemotherapy after interval debulking surgery in the treatment of ovarian cancer could lead to higher response rate and better survival outcomes.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Department of Abdominal Surgery (Section 2), Affiliated Tumor Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China
Contact Details
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
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