HIPEC and Systemic Chemotherapy in Unresectable Peritoneal Metastases From Colorectal Cancer

Not Applicable

Terminated

• Conditions: Peritoneal Metastases From Colorectal Cancer
• Interventions: Procedure: exploratory laparoscopy or laparotomy; Procedure: HIPEC; Drug: Systemic chemotherapy

• Registration Number: NCT03398512
• Lead Sponsor: Wuhan University

Brief 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.

Study Timeline

• Study First Submitted: 2018-01-04
• Study First Submitted QC: 2018-01-07
• Study First Posted: 2018-01-12
• Study Start: 2018-02-01
• Status Verified: 2020-03
• Primary Completion: 2020-03-20
• Study Completion: 2020-03-20
• Last Update Submitted: 2020-03-22
• Last Update Posted: 2020-03-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Histological proved diagnosis of colorectal cancer.
• Unresectable peritoneal metastases and primary tumor proved at surgery.
• No evidence of distant metastases.
• Have not received radiotherapy, chemotherapy or immunotherapy.
• ECOG score: 0~2.
• Written informed consent is obtained prior to commencement of trial treatment.

Exclusion Criteria

• Existence of distant metastasis outside the abdomen.
• Any previous radiotherapy, chemotherapy or immunotherapy.
• Active systemic infections.
• Inadequate cardiac function, renal function, liver function or bone marrow function at the beginning of the trial.
• Female patients who are pregnant or breast feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	exploratory laparoscopy or laparotomy	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.
Experimental	HIPEC	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.
Experimental	Systemic chemotherapy	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.

Primary Outcome Measures

Name	Time	Method
radical resection rate	3 months	The rate between the number of patients with radically resectable peritoneal metastases and those with unresectable peritoneal metastases

Secondary Outcome Measures

Name	Time	Method
overall survival	3 years	The overall survival time
complication rate	3 years	The rate of adverse complication
the Peritoneal Cancer Index score	3 months	The score range from 0 to 39, higher values represent a worse outcome

Trial Locations

Locations (1)

Wuhan University; 🇨🇳 Wuhan, Hubei, China