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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Rennes University Hospital
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT00264979
First received: December 12, 2005
Last updated: July 23, 2014
Last verified: July 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 222
Study Start Date: December 2005
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00264979

Contacts
Contact: Karim Boudjema, MD, PhD 33-2-9928-4265 karim.boudjema@chu-rennes.fr
Contact: Jean-Luc Raoul, MD 33-2-9925-3172 raoul@rennes.fnclcc.fr

Locations
France
Chirurgie générale viscérale et digestive - Hôpital Nord Recruiting
Amiens, France, 80080
Principal Investigator: Regimbeau Jean-Marc, MD         
Chirurgie Viscérale - CHU Angers Suspended
Angers, France, 49033
Service de Chirurgie viscérale, digestive et cancérologie - Hôpital Jean Mingoz Recruiting
Besancon, France, 25000
Contact: Georges Mantion, MD    33-3-8166-8243    georges.mantion@ufc-chu.univ-fcompte.fr   
Principal Investigator: Georges Mantion, MD         
Sub-Investigator: Bruno Heyd, MD         
Chirurgie Digestive - Hôpital Saint André Suspended
Bordeaux, France, 33075
Chirurgie Générale et Digestive - Hôpital Ambroise Paré Suspended
Boulogne-Billancourt, France, 92100
Chirurgie Générale - CHU La Cavale Blanche Suspended
Brest, France, 29609
Service de Chirurgie Digestive - Hôpital de la Côte de Nacre Suspended
Caen, France, 14033
Chirurgie Digestive - Hôtel Dieu Suspended
Clermont-Ferrand, France, 63058
Service d'Hépatogastroentérologie - Hôpital Beaujon Suspended
Clichy, France, 92110
Service de Chirurgie Digestive - Hôpital Henri Mondor Suspended
Créteil, France, 94010
Chirurgie digestive, thoracique et cancérologie Recruiting
Dijon, France, 21000
Contact: Jean Pierre Favre, MD    00-3-8029-3401    jean-pierre.favre@chu-dijon.fr   
Principal Investigator: Jean-Pierre Favre, MD         
Sub-Investigator: Patrick Rat, MD         
Département de Chirurgie Digestive et de l'Urgence - Hôpital Michallon Suspended
Grenoble, France, 38043
Fédération médico-chirurgicale des maladies de l'appareil digestif Suspended
Laval, France, 53015
Service de Chirurgie Viscérale et Transplantations - Hôpital Dupuytren Suspended
Limoges, France, 87042
Chirurgie Générale et Digestive - Hôpital de La Croix Rousse Suspended
Lyon, France, 69317
Département de Chirurgie - CRLCC Léon Bérard Suspended
Lyon, France, 69008
Chirurgie I - Institut Paoli Calmettes Suspended
Marseille, France, 13273
Chirurgie Digestive - Hôpital Saint Eloi Suspended
Montpellier, France, 34295
Clinique Chirurgicale I - Hôpital Nord Recruiting
Nantes, France, 44093
Contact: Jacques Paineau, MD    33-2-4016-5055    jacques.paineau@chu-nantes.fr   
Principal Investigator: Jacques Paineau, MD         
Clinique Chirurgicale A - Hôtel Dieu Recruiting
Nantes, France, 44093
Contact: Jean-Claude Le Neel, MD    33-2-4008-3041    jeanclaude.leneel@chu-nantes.fr   
Principal Investigator: Jean-Claude Le Neel, MD         
Sub-Investigator: Paul-Antoine Lehur, MD         
Chirurgie Générale - Hôpital Archet II Suspended
Nice, France, 06202
Service de Chirurgie hépato-biliaire et Transplantation Hépatique- Paris Saint Antoine Suspended
Paris, France
Département de Chirurgie - Hôpital Lariboisière Suspended
Paris, France, 75475
Centre de Chirurgie et Réanimation Digestives - Hôpital Saint Antoine Suspended
Paris, France, 75570
Service de Chirurgie - Hôpital Jean Bernard Suspended
Poitiers, France, 86021
Chirurgie Digestive, Centre Hospitalier de Cornouailles Suspended
Quimper, France, 29107
Département de Chirurgie Viscérale - Hôpital Pontchaillou Recruiting
Rennes, France, 35033
Contact: Karim Boudjema, MD, PhD    33-2-9928-4265    karim.boudjema@chu-rennes.fr   
Principal Investigator: Karim Boudjema, MD, PhD         
Sub-Investigator: Jean-Pierre Campion, MD         
Sub-Investigator: Bernard Meunier, MD         
Service d'Oncologie Digestive- CRLCC Eugène Marquis Recruiting
Rennes, France, 35000
Contact: Jean-Luc Raoul, MD    33-2-9925-3172    raoul@rennes.fnclcc.fr   
Principal Investigator: Jean-Luc Raoul, MD         
Chirurgie Digestive - CH La Beauchée Suspended
Saint Brieuc, France, 22023
Chirurgie Viscérale - CH Saint Malo Suspended
Saint Malo, France, 35400
Centre de Chirurgie Viscérale et de Transplantation - CHU de Hautepierre Recruiting
Strasbourg, France, 67098
Contact: Daniel Jaeck, MD    33-3-8812-7256    daniel.jaeck@chru-strasbourg.fr   
Principal Investigator: Daniel Jaeck, MD         
Sub-Investigator: Elie Oussoultzoglou, MD         
Chirurgie Digestive et Endocrinienne - Hôpital de Trousseau Suspended
Tours, France, 37044
Chirurgie Viscérale Digestive - CH Chubert Suspended
Vannes, France, 70555
Département de Chirurgie - Institut Gustave Roussy Suspended
Villejuif, France, 94805
Centre Hépato-biliaire - Hôpital Paul Brousse Suspended
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
Study First Received: December 12, 2005
Last Updated: July 23, 2014
Health Authority: France: Direction Générale de la Santé

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

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

ClinicalTrials.gov processed this record on September 16, 2014