Official Title: “Prospective Randomized Study Comparing the Morbidity and Mortality After Liver Resection for Synchronous Colorectal Cancer Metastases When Performed Either During or 12 to 14 Weeks After the Primary Resection”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: October 2009

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.

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

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

Primary Measures

• Rate of patients with at least one postoperative severe complication within 60 days after each surgery
  • Time Frame: 60 days after each surgery
    Safety Issue?: Yes

Secondary Measures

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

Inclusion Criteria:

• At least one adenocarcinoma of colon and/or rectum, histologically proven.
• No local complication
• At least one hepatic metastasis which resection is considered as class I: Possible through a conventional simple liver resection and with a residual liver volume/total liver volume rate > 40% as measured by CT scan
• Informed written consent.

Non inclusion criteria:

• Heart, Respiratory or Renal failure
• Physical or psychological dependence
• Chronic liver disease
• Extra-hepatic metastases
• Preoperative chemotherapy (except for adjuvant treatment of rectum cancer)
• 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 leading to modify the class of the liver resection
• Other hepatic lesions diagnosed with ultrasound modifying the class of the liver resection

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Rennes University Hospital

Overall Clinical Trial Officials and Contacts

Karim Boudjema, MD, PhD Principal Investigator CHU Rennes  

Overall Contact: Karim Boudjema, MD, PhD 33-2-9928-4265 karim.boudjema@chu-rennes.fr

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00264979

Study ID Number: DGS 2005/0193

ClinicalTrials.gov Identifier: NCT00264979

Health Authority: France: Direction Générale de la Santé