NCT03373058

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 310 (estimated)
• Sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epithelial Ovarian Cancer
• Fallopian Tube Cancer
• Primary Peritoneal Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Hyperthermic Intraperitoneal Chemotherapy	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.
PROCEDURE	cytoreductive surgery	Cytoreductive surgery (CRS) is performed when Faggoti value is less than 6 via laparoscopic exploration.
DRUG	adjuvant chemotherapy	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.

Timeline

• Start date: 2019-10-15
• Primary completion: 2021-07-01
• Completion: 2023-07-01
• First posted: 2017-12-14
• Last updated: 2019-11-06

Locations

7 sites across 1 country: China