HIPEC and Systemic Chemotherapy in Unresectable Peritoneal Metastases From Colorectal Cancer

Peritoneal Metastases From Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03398512
• Other study ID #: WuhanU_Peritoneal M_colon
• Status: Terminated
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: March 20, 2020

Study information

• Verified date: March 2020
• Source: Wuhan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: March 20, 2020
• Est. primary completion date: March 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Neoplasm Metastasis
• Peritoneal Metastases From Colorectal Cancer

Intervention

Procedure:
• exploratory laparoscopy or laparotomy
Exploratory laparoscopy or laparotomy, for PCI score or radical colorectal resection and cytoreductive surgery
• 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

Locations

Country	Name	City	State
China	Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	radical resection rate	The rate between the number of patients with radically resectable peritoneal metastases and those with unresectable peritoneal metastases	3 months
Secondary	the Peritoneal Cancer Index score	The score range from 0 to 39, higher values represent a worse outcome	3 months
Secondary	overall survival	The overall survival time	3 years
Secondary	complication rate	The rate of adverse complication	3 years