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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
310
HIPEC is performed as postoperative chemotherapy after cytoreductive surgery for advanced-stage epithelial ovarian cancer. The first HIPEC is conducted within 48h after cytoreductive surgery: Paclitaxel 175 mg/m\^2, 43°C, 90min. The second HIPEC is performed after 48 hours of the first HIPEC. The HIPEC regimens are Docetaxel 75 mg/m\^2 and cisplatin 75 mg/m\^2, respectively, 43°C, 90min.
Cytoreductive surgery (CRS) is performed when Faggoti value is less than 6 via laparoscopic exploration.
Systemic chemotherapy regimens after HIPEC treatment are paclitaxel 175 mg/m\^2 IV\>3 hour+ carboplatin AUC = 5-6 IV\>1 hour, every 3 weeks for 2 cycles in experimental group. Systemic chemotherapy regimens after IDS are paclitaxel 175 mg/m\^2 IV\>3 hour+ carboplatin AUC = 5-6 IV\>1 hour, every 3 weeks for 3 cycles in control group.
Affiliated Tumor Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGSun Yat-sen Memorial Hospital,Sun Yat-sen University
Guanzhou, Guangdong, China
RECRUITINGBeijing Cancer Hospital
Beijing, China
Median recurrence-free survival
assess median recurrence-free survival during 3 years in both study arms
Time frame: 3 years
Median overall survival
assess median overall survival during 3 years in both study arms
Time frame: 3 years
Median progression-free survival
assess median progression-free survival during 3 years in both study arms
Time frame: 3 years
Risk factors for morbidity and mortality
The early complication and mortality are defined as the event observed within 30 days after intervention, while the time frame for late complication is the period beyond 30 days after intervention to the end of 3 years. Complications are ranked from grade 0-5 according to CTCAE V4.0
Time frame: 30 days; 3 years
Quality of life for ovarian cancer
Evaluated according to European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Ovarian Cancer Module (QLQ-OV28)
Time frame: 3 years
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Chongqing Cancer Hospital
Chongqing, China
RECRUITINGThe First Affiliated Hospital of Chongqing Medical University
Chongqing, China
RECRUITINGHubei General Hospital
Wuhan, China
RECRUITINGHenan Cancer Hospital
Zhengzhou, China
RECRUITING