HIPEC and Systemic Chemotherapy in Unresectable Peritoneal Metastases From Colorectal Cancer

NCT03398512 | Terminated DMC

• 1 other identifier: WuhanU_Peritoneal M_colon
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Peritoneal Metastases From Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• radical resection rate

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

  3 months

Secondary Outcomes (3)

• the Peritoneal Cancer Index score

  3 months

• overall survival

  3 years

• complication rate

  3 years

Study Arms (1)

Experimental

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.

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

Interventions

exploratory laparoscopy or laparotomy PROCEDURE

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

Experimental

HIPEC PROCEDURE

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

Experimental

Systemic chemotherapy DRUG

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

Experimental

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wuhan University: lead

Study Sites (1)

Wuhan University

Wuhan, Hubei, China

Location

MeSH Terms

Interventions

Laparotomy; Hyperthermic Intraperitoneal Chemotherapy; Neoadjuvant Therapy

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Zhongnan Hospital

Study Record Dates

• First Submitted: January 4, 2018
• First Posted: January 12, 2018
• Study Start: February 1, 2018
• Primary Completion: March 20, 2020
• Study Completion: March 20, 2020
• Last Updated: March 24, 2020

Record last verified: 2020-03

Locations

CN (1)