Efficacy of HIPEC in the Treatment of Advanced-Stage Epithelial Ovarian Cancer After Cytoreductive Surgery
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
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.
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.
Median recurrence-free survival
Median overall survival
Epithelial Ovarian Cancer
Hyperthermic Intraperitoneal Chemotherapy
Study Arms / Comparison Groups
Description: Cytoreductive surgery Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Docetaxel 75 mg/m^2 and cisplatin 75 mg/m^2 intraperitoneally in succession 6 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour(Docetaxel 75 mg/m^2, if paclitaxel is not available.)+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
October 15, 2019
July 1, 2023
Primary Completion Date
July 1, 2021
Inclusion Criteria: - Disease status primary epithelial ovarian cancer, tubal cancer, and primary peritoneal cancer (Stage III ) - Fagotti score by laparoscopic exploration < 6 - Residual tumor < 1cm after completion of cytoreductive surgery - 18 < Age < 70 year old - Expected survival > 3 months - Performance status: ECOG 0-1 - Adequate bone marrow function Hb ≥8 g/dl (After correction in case of iron deficient anemia) WBC ≥ 3,000/mm3, Platelet ≥ 100,000/mm3 - Adequate renal function Creatinine ≤ 1.5 mg/dl, and adequate hepatic function Bilirubin ≤ 1.5 mg/dl and AST and ALT ≤ 80 IU/L - Voluntary participation after getting written informed consent. Exclusion Criteria: - Fagotti score by laparoscopic exploration >= 6 - Suboptimal debulking (residual tumor > 1cm) - Extensive adhesion in peritoneal cavity - Previous History of other malignancies (except excision of skin cancer, thyroid cancer) - Poorly controlled disease e.g. atrial fibrillation, stenocardia, cardiac insufficiency, persistent hypertension despite medicinal treatment, ejection fraction<50% - Receiving other chemotherapy, radiotherapy or immunotherapy - Patients who are unsuitable candidates by doctor's decision - Without given written informed consent
18 Years - 70 Years
Accepts Healthy Volunteers
Shuzhong Cui, M.D, 0086-138-0251-3800, [email protected]
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Shuzhong Cui, M.D, Study Director, Affiliated Cancer Hospital & Institute of Guangzhou Medical University