NCT03398512

HIPEC and Systemic Chemotherapy in Unresectable Peritoneal Metastases From Colorectal Cancer

A Study of Conversion Therapy Using Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) and Systemic Oxaliplatin/Capecitabine Chemotherapy in Unresectable Peritoneal Metastases From Colorectal Cancer

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Wuhan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The prognosis of patients with unresectable peritoneal metastases from colorectal cancer is poor. These patients may obtain survival benefit from radical colorectal resection and cytoreductive surgery (CRS). The response rates of previous conversion therapy are low. Hyperthermic intraperitoneal chemoperfusion (HIPEC) and systemic chemotherapy are effective methods of reducing peritoneal cancer index (PCI) levels. The purpose of this study is to investigate the efficacy and safety of HIPEC and systemic chemotherapy in the conversion therapy of peritoneal metastases from colorectal cancer.

Detailed description

To determine the efficacy and safety of HIPEC and systemic chemotherapy in the conversion therapy of peritoneal metastases from colorectal cancer, patients undergo HIPEC with Raltitrexed at the time of fist surgery and twice repeat within one week after the surgery, following 3 cycles of 3-week Oxaliplatin/Capecitabine chemotherapy. The second surgery, exploratory laparoscopy or laparotomy, is carried out one week later after the series of systemic chemotherapy.

Conditions

• Peritoneal Metastases From Colorectal Cancer

Interventions

Type	Name	Description
PROCEDURE	exploratory laparoscopy or laparotomy	Exploratory laparoscopy or laparotomy, for PCI score or radical colorectal resection and cytoreductive surgery
PROCEDURE	HIPEC	Normal saline 3000ml-4000ml, Raltitrexed 4mg, 43°C, 60min.
DRUG	Systemic chemotherapy	Oxaliplatin: 130mg/m2, day 1. Capecitabine: 1500mg, twice daily for two weeks, and then suspend for one week

Timeline

• Start date: 2018-02-01
• Primary completion: 2020-03-20
• Completion: 2020-03-20
• First posted: 2018-01-12
• Last updated: 2020-03-24

Locations

1 site across 1 country: China