Ignite Creation Date:
2024-05-06 @ 2:58 AM
Last Modification Date:
2024-10-26 @ 11:26 AM
Study NCT ID:
NCT02179489
Status:
COMPLETED
Last Update Posted:
2022-06-27
First Post:
2014-06-21
Brief Title:
Surgery With HIPEC in Treating Patients With a High Risk of Developing Colorectal Peritoneal Carcinomatosis
Sponsor:
Zhejiang University
Organization:
Zhejiang University
Study Overview
Official Title:
Randomized Multicentric Phase III Trial Comparing Simple Surgery to Surgery Plus HIPEC Hyperthermic Intraperitoneal Chemotherapy With MMC in Colorectal Patients Who Have a High Risk of Developing Colorectal Peritoneal Carcinomatosis
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
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:
Multicentric randomised trial The goal of this clinical research study is to learn if hyperthermic intraperitoneal chemotherapy HIPEC will help to decrease the rate of peritoneal carcinomatosisPC in patients with high risk of developing PC of colorectal cancer The safety of this treatment will also be studied
Detailed Description:
Hyperthermic intraperitoneal chemotherapyHIPEC is a recently validated option for the treatment of peritoneal carcinomatosis from colorectal or ovarian origin This therapeutic program demonstrated a significant improvement of overall survival of the disease It is not yet known whether surgery followed by HIPEC is effective on decreasing the rate of peritoneal carcinomatosisPC in patients with high risk of developing PC of colorectal cancerPatients with a high risk of developing colorectal Peritoneal Carcinomatosis PC defined by Colorectal Cancer With a Resected Minimal Synchronous PC or Ovarian Metastases or identified T4 by intraoperative pathological diagnosis or Tumour Rupture in the Abdominal Cavity If patients with a high risk of developing PC identified by preoperative examination they will be informed and will sign the consent After complete resection of their tumor they will be randomised to surveillance alone control group or HIPEC experimental group All patients will receive the current standard postoperative adjuvant treatment 6 months of systemic chemotherapy currently including FOLFOX4 mFOLFOX6 CapeOx or Capecitabine regimen which could be modified if the standard is modified Then a work-up is done to find recurrence If the recurrence occurs the patient will be treated with the best known treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None