Evaluation of 2 Resection Strategies of Synchronous Colorectal Cancer Metastases (METASYNC)

• Death rate during hospitalization or within 60 days after each surgery [ Time Frame: 60 days after each surgery ] [ Designated as safety issue: Yes ]
• Rate and number of severe general, digestive or hepatic complications [ Time Frame: 2 years after the first surgery ] [ Designated as safety issue: Yes ]
• Rate of unachieved hepatic resection [ Time Frame: Day of the hepatic surgery ] [ Designated as safety issue: No ]
• Global survival distribution and 2 years global survival rate [ Time Frame: 2 years after the first surgery ] [ Designated as safety issue: Yes ]
• Recurrence-free survival distribution and 2 years recurrence-free survival rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
• Two years recurrence rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

• - Death rate during hospitalization or within 60 days after each surgery
• - Rate and number of severe general, digestive or hepatic complications
• - Rate of unachieved hepatic resection
• - Global survival distribution and 2 years global survival rate
• - Recurrence-free survival distribution and 2 years recurrence-free survival rate
• - Two years recurrence rate

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.

• Colorectal Cancer
• Hepatic Metastases

• Procedure: Simultaneous surgery
  Simultaneous surgery of colorectal cancer and synchronous liver metastases
• Procedure: Sequential surgery
  Sequential surgeries of colorectal cancer and synchronous liver metastases: the metastases surgery will be programmed 12 to 14 weeks after the primary tumour exeresis.

• 1
  Simultaneous surgery of colorectal cancer and synchronous liver metastases
  Intervention: Procedure: Simultaneous surgery
• 2
  Sequential surgeries of colorectal cancer and synchronous liver metastases
  Intervention: Procedure: Sequential surgery

• Martin R, Paty P, Fong Y, Grace A, Cohen A, DeMatteo R, Jarnagin W, Blumgart L. Simultaneous liver and colorectal resections are safe for synchronous colorectal liver metastasis. J Am Coll Surg. 2003 Aug;197(2):233-41; discussion 241-2.
• Weber JC, Bachellier P, Oussoultzoglou E, Jaeck D. Simultaneous resection of colorectal primary tumour and synchronous liver metastases. Br J Surg. 2003 Aug;90(8):956-62.

Inclusion Criteria:

• Male and female adults over 18 years old
• At least one adenocarcinoma of colon and/or rectum, histologically proven.
• No local complication at the time of surgery (no occlusion, no sub-occlusion, no massive hemorrhage, no abscesses or local invasion)
• At least one hepatic metastasis which R0 resection is possible through a conventional simple resection
• Informed written consent.

Non inclusion criteria:

• Heart, Respiratory or Renal failure
• Physical or psychological dependence
• Chronic liver disease
• Extra-hepatic metastases

Exclusion Criteria (at time of surgery)

• Localized or diffuse peritoneal carcinomatosis
• Non resectable lymph node metastases
• Colorectal or hepatic tumour extension towards abdominal wall and/or adjacent organ making liver R0 resection impossible immediately
• Other hepatic lesions diagnosed with ultrasound making liver R0 resection impossible immediately