HIPEC and Systemic Chemotherapy in Unresectable Peritoneal Metastases From Colorectal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2020-03-20

Brief Summary

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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.

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Detailed Description

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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

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Peritoneal Metastases From Colorectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental

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.

Group Type EXPERIMENTAL

exploratory laparoscopy or laparotomy

Intervention Type PROCEDURE

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

HIPEC

Intervention Type PROCEDURE

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

Systemic chemotherapy

Intervention Type DRUG

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

Interventions

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exploratory laparoscopy or laparotomy

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

Intervention Type PROCEDURE

HIPEC

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

Intervention Type PROCEDURE

Systemic chemotherapy

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No