HIPEC and Systemic Chemotherapy in Unresectable Peritoneal Metastases From Colorectal Cancer

Wuhan University

Status: Terminated

Conditions: Peritoneal Metastases From Colorectal Cancer

Treatments: Procedure: HIPEC; Procedure: exploratory laparoscopy or laparotomy; Drug: Systemic chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03398512

WuhanU_Peritoneal M_colon

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Experimental

Experimental group

Description:

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.

Treatment:

Procedure: exploratory laparoscopy or laparotomy

Procedure: HIPEC

Drug: Systemic chemotherapy