Trial Comparing Simple Follow-up to Exploratory Laparotomy Plus "in Principle" (Hyperthermic Intraperitoneal Chemotherapy) HIPEC in Colorectal Patients
NCT01226394
Interventional
Phase 3
Unknown status
ProphyloCHIP
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).
Apr 30,2010
All
18 Years
70 Years
18 Years
70 Years
130