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

This study has been terminated.
(Stop recommended following the last sequential analysis)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00264979
First Posted: December 13, 2005
Last Update Posted: August 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Rennes University Hospital
  Purpose
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.

Condition Intervention
Colorectal Cancer Hepatic Metastases Procedure: Simultaneous surgery Procedure: Sequential surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • Rate of patients with at least one postoperative severe complication within 60 days after each surgery [ Time Frame: 60 days after each surgery ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 105
Study Start Date: December 2005
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Simultaneous surgery of colorectal cancer and synchronous liver metastases
Procedure: Simultaneous surgery
Simultaneous surgery of colorectal cancer and synchronous liver metastases
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.

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.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00264979


Locations
France
Chirurgie générale viscérale et digestive - Hôpital Nord
Amiens, France, 80080
Service de Chirurgie viscérale, digestive et cancérologie - Hôpital Jean Mingoz
Besancon, France, 25000
Chirurgie digestive, thoracique et cancérologie
Dijon, France, 21000
Département de Chirurgie - CRLCC Léon Bérard
Lyon, France, 69008
Clinique Chirurgicale A - Hôtel Dieu
Nantes, France, 44093
Clinique Chirurgicale I - Hôpital Nord
Nantes, France, 44093
Centre de Chirurgie et Réanimation Digestives - Hôpital Saint Antoine
Paris, France, 75570
Service de Chirurgie hépato-biliaire et Transplantation Hépatique- Paris Saint Antoine
Paris, France
Service de Chirurgie - Hôpital Jean Bernard
Poitiers, France, 86021
Service d'Oncologie Digestive- CRLCC Eugène Marquis
Rennes, France, 35000
Département de Chirurgie Viscérale - Hôpital Pontchaillou
Rennes, France, 35033
Centre de Chirurgie Viscérale et de Transplantation - CHU de Hautepierre
Strasbourg, France, 67098
Chirurgie Viscérale Digestive - CH Chubert
Vannes, France, 70555
Centre Hépato-biliaire - Hôpital Paul Brousse
Villejuif, France
Sponsors and Collaborators
Rennes University Hospital
Ministry of Health, France
Investigators
Principal Investigator: Karim Boudjema, MD, PhD CHU Rennes
Principal Investigator: Jean-Luc Raoul, MD Centre Eugène Marquis - CRLCC Rennes
Study Chair: Eric Bellissant, MD, PhD CHU Rennes
  More Information

Publications:
Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT00264979     History of Changes
Other Study ID Numbers: DGS 2005/0193
PHRC/04-01
CIC0203/030
First Submitted: December 12, 2005
First Posted: December 13, 2005
Last Update Posted: August 22, 2017
Last Verified: August 2017

Keywords provided by Rennes University Hospital:
Colorectal cancer
Sequential or simultaneous surgery
Synchronous hepatic metastases

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases