Ignite Creation Date:
2024-05-06 @ 10:18 AM
Last Modification Date:
2024-10-26 @ 12:28 PM
Study NCT ID:
NCT03221608
Status:
UNKNOWN
Last Update Posted:
2017-07-18
First Post:
2017-07-17
Brief Title:
Clinical Analysis of HIPEC for T4 Colorectal Cancer After Surgery
Sponsor:
Sixth Affiliated Hospital Sun Yat-sen University
Organization:
Sixth Affiliated Hospital Sun Yat-sen University
Study Overview
Official Title:
Clinical Study of the Impact of Hyperthermic Intraperitoneal Chemotherapy on Peritoneal Recurrence and Prognosis of Patients With Stage T4 Colorectal Cancer After Radical Surgery A Multicentre Randomised Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2017-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This multicentric study aims to determine if hyperthermic intraperitoneal chemotherapy HIPEC will help to prevent the development of peritoneal carcinomatosis in addition to the standard adjuvant systemic treatment after surgery
Detailed Description:
Background
Colorectal cancer CRC is the third most common malignancy worldwide nearly 14 million new cases every year for about 694000 deaths Surgery is the primary treatment and results in a cure rate of approximately 50 of the patients However recurrence following surgery is a major problem the second most common site of recurrence was peritoneum which was as a result of the intraperitioneal free cancer cells FCC and microscopic cancer MC The remaining free cancers and microscopic cancer in abdominal cavity can not be killed completely because of the peritoneal-plasma barrier and non-sufficient drug concentration in abdominal cavity by systemic venous chemotherapy In recent years hyperthermic intraperitioneal chemotherapyHIPEC has already been shown to be effective in improving the 5 year survival rate of colorectal cancer However lots of clinically studies for patients with colorectal cancer are advanced it is not sure yet whether surgery combined with HIPEC is effective on decreasing the rate of peritoneal carcinomatosis in T4 stage colorectal cancer The efficacy tend to be magnified when stage T4 patients account for less confusing HIPEC for treatment of patients with advanced colorectal cancer Therefore the aim of this study is to investigate the clinical efficacy of HIPEC in T4 stage patients ruling out the effects of different T stages on curative effect The results of this study will hopefully provide the clinical basis for improving the prognosis of patients with advanced colorectal cancer
Study design This is a multicenter study in which 300 patients with T4 colorectal cancer will be randomized to surveillance alone control group or HIPEC experimental group after resection of the primary tumor either by laparoscopy or open approach Subsequently all patients started mfolfox6 chemotherapy after operation in a month Adverse reaction of chemotherapy during chemotherapy and post chemotherapy period will be recorded
Study population
The patients with colorectal cancer T4N0-2M0 will undergo a curative resection by laparoscopy or open approach
Intervention
HIPEC equipment used in the perfusion fluid Lobaplatin of 50mg completely dissolved in 3000ml saline solution is headed to 43 Then it is injected into the peritoneal cavity by flow velocity of 200-400mlmin for 60 minutes
Outcomes
Primary endpoint is incidence of endoperitoneal recurrence at 36 months Secondary endpoints are disease-free survival overall survival incidence of peritoneal carcinomatosis at end of follow-up with or without concomitant liverlung metastases quality of life and morbidity rate
Colorectal cancer CRC is the third most common malignancy worldwide nearly 14 million new cases every year for about 694000 deaths Surgery is the primary treatment and results in a cure rate of approximately 50 of the patients However recurrence following surgery is a major problem the second most common site of recurrence was peritoneum which was as a result of the intraperitioneal free cancer cells FCC and microscopic cancer MC The remaining free cancers and microscopic cancer in abdominal cavity can not be killed completely because of the peritoneal-plasma barrier and non-sufficient drug concentration in abdominal cavity by systemic venous chemotherapy In recent years hyperthermic intraperitioneal chemotherapyHIPEC has already been shown to be effective in improving the 5 year survival rate of colorectal cancer However lots of clinically studies for patients with colorectal cancer are advanced it is not sure yet whether surgery combined with HIPEC is effective on decreasing the rate of peritoneal carcinomatosis in T4 stage colorectal cancer The efficacy tend to be magnified when stage T4 patients account for less confusing HIPEC for treatment of patients with advanced colorectal cancer Therefore the aim of this study is to investigate the clinical efficacy of HIPEC in T4 stage patients ruling out the effects of different T stages on curative effect The results of this study will hopefully provide the clinical basis for improving the prognosis of patients with advanced colorectal cancer
Study design This is a multicenter study in which 300 patients with T4 colorectal cancer will be randomized to surveillance alone control group or HIPEC experimental group after resection of the primary tumor either by laparoscopy or open approach Subsequently all patients started mfolfox6 chemotherapy after operation in a month Adverse reaction of chemotherapy during chemotherapy and post chemotherapy period will be recorded
Study population
The patients with colorectal cancer T4N0-2M0 will undergo a curative resection by laparoscopy or open approach
Intervention
HIPEC equipment used in the perfusion fluid Lobaplatin of 50mg completely dissolved in 3000ml saline solution is headed to 43 Then it is injected into the peritoneal cavity by flow velocity of 200-400mlmin for 60 minutes
Outcomes
Primary endpoint is incidence of endoperitoneal recurrence at 36 months Secondary endpoints are disease-free survival overall survival incidence of peritoneal carcinomatosis at end of follow-up with or without concomitant liverlung metastases quality of life and morbidity rate
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None