An interventional study of exploratory laparoscopy or laparotomy and HIPEC in Peritoneal Metastases From Colorectal Cancer, sponsored by Wuhan University. Terminated at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-03-24.
Sponsored by Wuhan University · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
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
Exploratory laparoscopy or laparotomy, for PCI score or radical colorectal resection and cytoreductive surgery
Normal saline 3000ml-4000ml, Raltitrexed 4mg, 43°C, 60min.
Oxaliplatin: 130mg/m2, day 1. Capecitabine: 1500mg, twice daily for two weeks, and then suspend for one week
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
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
Time frame: 3 years
This study is terminated, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Wuhan University