Peritoneal Metastases From Colorectal Cancer
Conditions
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.
Detailed 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.
Interventions
Exploratory laparoscopy or laparotomy, for PCI score or radical colorectal resection and cytoreductive surgery
PROCEDUREHIPEC
Normal saline 3000ml-4000ml, Raltitrexed 4mg, 43°C, 60min.
DRUGSystemic chemotherapy
Oxaliplatin: 130mg/m2, day 1. Capecitabine: 1500mg, twice daily for two weeks, and then suspend for one week
Sponsors
Wuhan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| radical resection rate | 3 months | The rate between the number of patients with radically resectable peritoneal metastases and those with unresectable peritoneal metastases |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the Peritoneal Cancer Index score | 3 months | The score range from 0 to 39, higher values represent a worse outcome |
| overall survival | 3 years | The overall survival time |
| complication rate | 3 years | The rate of adverse complication |
Countries
China
Outcome results
None listed