The surgical strategy for the treatment of synchronous colorectal cancer liver metastases has not still been defined. The purpose of this study is to compare two treatment strategies in which liver resection is performed either during, or 12 to 14 weeks after the primary resection. Endpoints include the rate of severe complications and survival.
In France, 35 000 colorectal cancers are diagnosed each year, 15 to 25% of which with hepatic metastases. It is nowadays admitted that the complete resection of these hepatic metastases represents the only treatment that has been shown to increase survival. The aim of this study is to evaluate the efficacy/safety ratio of the liver surgery when performed simultaneously or at distance of the primitive tumour ablation. Patients are randomized to undergo liver surgery either during, or 12 to 14 weeks after the primary resection. The primary endpoint is the rate of patients with at least one severe complication within 60 days after surgery. Secondary endpoints evaluate long-term clinical outcomes, in particular recurrence-free survival.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
105
Simultaneous surgery of colorectal cancer and synchronous liver metastases
Sequential surgeries of colorectal cancer and synchronous liver metastases: the metastases surgery will be programmed 12 to 14 weeks after the primary tumour exeresis.
Chirurgie générale viscérale et digestive - Hôpital Nord
Amiens, France
Service de Chirurgie viscérale, digestive et cancérologie - Hôpital Jean Mingoz
Besançon, France
Rate of patients with at least one postoperative severe complication within 60 days after each surgery
Time frame: 60 days after each surgery
Death rate during hospitalization or within 60 days after each surgery
Time frame: 60 days after each surgery
Rate and number of severe general, digestive or hepatic complications
Time frame: 2 years after the first surgery
Rate of unachieved hepatic resection
Time frame: Day of the hepatic surgery
Global survival distribution and 2 years global survival rate
Time frame: 2 years after the first surgery
Recurrence-free survival distribution and 2 years recurrence-free survival rate
Time frame: 2 years
Two years recurrence rate
Time frame: 2 years
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Chirurgie digestive, thoracique et cancérologie
Dijon, France
Département de Chirurgie - CRLCC Léon Bérard
Lyon, France
Clinique Chirurgicale A - Hôtel Dieu
Nantes, France
Clinique Chirurgicale I - Hôpital Nord
Nantes, France
Centre de Chirurgie et Réanimation Digestives - Hôpital Saint Antoine
Paris, France
Service de Chirurgie hépato-biliaire et Transplantation Hépatique- Paris Saint Antoine
Paris, France
Service de Chirurgie - Hôpital Jean Bernard
Poitiers, France
Service d'Oncologie Digestive- CRLCC Eugène Marquis
Rennes, France
...and 4 more locations