Clinical Trial: Trial Comparing Simple Follow-up to Exploratory Laparotomy Plus "in Principle" (Hyperthermic Intraperitoneal Chemotherapy) HIPEC in Colorectal Patients

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Multicentric Phase III Trial Comparing Simple Follow-up to Exploratory Laparotomy Plus "in Principle" HIPEC (Hyperthermic Intraperitoneal Chemotherapy) in Colorectal Patients Initially Treat

Brief Summary: Multicentric randomised trial. Patients with a high risk of developing colorectal Peritoneal Carcinomatosis (PC) after resection of their primary will be informed, will sign the consent and will be pre-registered. All patients will receive the current standard adjuvant treatment : 6 months of systemic chemotherapy (currently the Folfox-4 regimen which could be modified if the standard is modified). Then a work-up is done to exclude recurrence. The likelihood of a recurrence is low but if this occurs, the patient will not be randomised and will be treated with the best known treatment. If the work-up is negative, patients will be randomised to surveillance alone (control group) or exploratory laparotomy + HIPEC (experimental group).

Detailed Summary:
Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Current Primary Outcome: To increase the 3-year disease-free survival [ Time Frame: 3 years ]

3-year disease-free survival


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 3 year overall survival [ Time Frame: 3 years ]
  • Peritoneal disease-free survival [ Time Frame: 3 years ]
  • 5 year overall survival [ Time Frame: 5 years ]


Original Secondary Outcome:

  • 3- and 5-year overall survival [ Time Frame: 3 and 5 years ]
  • Peritoneal disease-free survival [ Time Frame: 3 years ]


Information By: Gustave Roussy, Cancer Campus, Grand Paris

Dates:
Date Received: October 20, 2010
Date Started: April 2010
Date Completion: June 2019
Last Updated: January 25, 2017
Last Verified: January 2017