HIPEC and Systemic Chemotherapy in Unresectable Peritoneal Metastases From Colorectal Cancer

Study Overview
=================
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.

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

Conditions
-----------------
Peritoneal Metastases From Colorectal Cancer

Intervention / Treatment
-----------------
* Procedure: exploratory laparoscopy or laparotomy
* Procedure: HIPEC
* Drug: Systemic chemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>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. | Procedure: exploratory laparoscopy or laparotomy<br>* Exploratory laparoscopy or laparotomy, for PCI score or radical colorectal resection and cytoreductive surgery<br>Procedure: HIPEC<br>* Normal saline 3000ml-4000ml, Raltitrexed 4mg, 43°C, 60min.<br>Drug: Systemic chemotherapy<br>* Oxaliplatin: 130mg/m2, day 1. Capecitabine: 1500mg, twice daily for two weeks, and then suspend for one week<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| radical resection rate | The rate between the number of patients with radically resectable peritoneal metastases and those with unresectable peritoneal metastases | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Peritoneal Cancer Index score | The score range from 0 to 39, higher values represent a worse outcome | 3 months | 
| overall survival | The overall survival time | 3 years | 
| complication rate | The rate of adverse complication | 3 years |