HIPEC and Systemic Chemotherapy in Unresectable Peritoneal Metastases From Colorectal Cancer

Wuhan University15 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Peritoneal Metastases From Colorectal Cancer

Interventions

exploratory laparoscopy or laparotomyPROCEDURE

Exploratory laparoscopy or laparotomy, for PCI score or radical colorectal resection and cytoreductive surgery

HIPECPROCEDURE

Normal saline 3000ml-4000ml, Raltitrexed 4mg, 43°C, 60min.

Systemic chemotherapyDRUG

Oxaliplatin: 130mg/m2, day 1. Capecitabine: 1500mg, twice daily for two weeks, and then suspend for one week

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

radical resection rate

The rate between the number of patients with radically resectable peritoneal metastases and those with unresectable peritoneal metastases

Time frame: 3 months

Secondary Outcomes

the Peritoneal Cancer Index score

The score range from 0 to 39, higher values represent a worse outcome

Time frame: 3 months

overall survival

The overall survival time

Time frame: 3 years

complication rate

The rate of adverse complication