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
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Median recurrence-free survival
Secondary Outcome
Median overall survival
Condition
Epithelial Ovarian Cancer
Intervention
Hyperthermic Intraperitoneal Chemotherapy
Study Arms / Comparison Groups
Experimental group
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
310
Start Date
October 15, 2019
Completion Date
July 1, 2023
Primary Completion Date
July 1, 2021
Eligibility Criteria
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
Gender
Female
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
Shuzhong Cui, M.D, 0086-138-0251-3800, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03373058
Organization ID
HIPEC-03
Responsible Party
Sponsor
Study Sponsor
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Sponsor
Shuzhong Cui, M.D, Study Director, Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Verification Date
November 2019