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

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 Overview

• Status: Terminated
• Conditions: Colorectal Cancer; Hepatic Metastases
• Intervention / Treatment: Procedure: Simultaneous surgery; Procedure: Sequential surgery

Detailed Description

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
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80080
    • Chirurgie générale viscérale et digestive - Hôpital Nord
  • Besancon, France, 25000
    • Service de Chirurgie viscérale, digestive et cancérologie - Hôpital Jean Mingoz
  • Dijon, France, 21000
    • Chirurgie digestive, thoracique et cancérologie
  • Lyon, France, 69008
    • Département de Chirurgie - CRLCC Léon Bérard
  • Nantes, France, 44093
    • Clinique Chirurgicale A - Hôtel Dieu
  • Nantes, France, 44093
    • Clinique Chirurgicale I - Hôpital Nord
  • Paris, France, 75570
    • Centre de Chirurgie et Réanimation Digestives - Hôpital Saint Antoine
  • Paris, France
    • Service de Chirurgie hépato-biliaire et Transplantation Hépatique- Paris Saint Antoine
  • Poitiers, France, 86021
    • Service de Chirurgie - Hôpital Jean Bernard
  • Rennes, France, 35000
    • Service d'Oncologie Digestive- CRLCC Eugène Marquis
  • Rennes, France, 35033
    • Département de Chirurgie Viscérale - Hôpital Pontchaillou
  • Strasbourg, France, 67098
    • Centre de Chirurgie Viscérale et de Transplantation - CHU de Hautepierre
  • Vannes, France, 70555
    • Chirurgie Viscérale Digestive - CH Chubert
  • Villejuif, France
    • Centre Hépato-biliaire - Hôpital Paul Brousse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 1; Simultaneous surgery of colorectal cancer and synchronous liver metastases	Procedure: Simultaneous surgery; Simultaneous surgery of colorectal cancer and synchronous liver metastases
Other: 2; Sequential surgeries 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of patients with at least one postoperative severe complication within 60 days after each surgery	60 days after each surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Karim Boudjema, MD, PhD, CHU Rennes; Principal Investigator: Jean-Luc Raoul, MD, Centre Eugène Marquis - CRLCC Rennes

Publications and helpful links

General Publications

• 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. doi: 10.1016/S1072-7515(03)00390-9.
• 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. doi: 10.1002/bjs.4132.

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2006
• Primary Completion (Actual): December 11, 2017
• Study Completion (Actual): December 11, 2017

Study Registration Dates

• First Submitted: December 12, 2005
• First Submitted That Met QC Criteria: December 12, 2005
• First Posted (Estimate): December 13, 2005

Study Record Updates

• Last Update Posted (Actual): March 11, 2019
• Last Update Submitted That Met QC Criteria: March 8, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Colorectal cancer; Sequential or simultaneous surgery; Synchronous hepatic metastases
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Processes; Colorectal Neoplasms; Neoplasm Metastasis
• Other Study ID Numbers: DGS 2005/0193; PHRC/04-01; CIC0203/030

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No