Evaluation of 2 Resection Strategies of Synchronous Colorectal Cancer Metastases - Full Text View

Sponsor:	Rennes University Hospital
Collaborator:	Ministry of Health, France
Information provided by:	Rennes University Hospital
ClinicalTrials.gov Identifier:	NCT00264979

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

MedlinePlus related topics: Cancer Colorectal Cancer Surgery

U.S. FDA Resources

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 Primary Completion Date:	October 2009 (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.

Contacts and Locations

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
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 Viscérale - CHU Angers	Recruiting
Angers, France, 49033
Contact: Jean-Pierre Arnaud, MD 33-2-4135-3618 Jparnaud@chu-angers.fr
Principal Investigator: Jean-Pierre Arnaud, MD
Service de Chirurgie viscérale, digestive et cancérologie - Hôpital Jean Mingoz	Recruiting
Besancon, France, 25000
Contact: Georges Mancion, MD 33-3-8166-8243 georges.mancion@ufc-chu.univ-fcompte.fr
Principal Investigator: Georges Mancion, MD
Sub-Investigator: Bruno Heyd, MD
Chirurgie Digestive - Hôpital Saint André	Recruiting
Bordeaux, France, 33075
Contact: Jean Saric, MD 33-5-5679-5810 jean.saric@chu-bordeaux.fr
Principal Investigator: Jean Saric, MD
Sub-Investigator: Christophe Laurent, MD
Chirurgie Générale - CHU La Cavale Blanche	Recruiting
Brest, France, 29609
Contact: Patrick Lozach, MD 33-2-9834-7224 patrick.lozach@wanadoo.fr
Principal Investigator: Patrick Lozach, MD
Service de Chirurgie Digestive - Hôpital de la Côte de Nacre	Recruiting
Caen, France, 14033
Contact: Philippe Segol, MD 33-2-3106-5020 segol.ph@chu-caen.fr
Principal Investigator: Philippe Segol, MD
Sub-Investigator: Laurence Chiche, MD
Chirurgie Digestive - Hôtel Dieu	Recruiting
Clermont-Ferrand, France, 63058
Contact: Philippe Chipponi, MD 33-4-7375-0494 jchipponi@chu-clermontferrand.fr
Principal Investigator: Philippe Chipponi, MD
Sub-Investigator: Karem Slim, MD
Service d'Hépatogastroentérologie - Hôpital Beaujon	Recruiting
Clichy, France, 92110
Contact: Jacques Belghiti, MD 33-1-4087-5895 j.belghiti@bjn.aphp.fr
Principal Investigator: Jacques Belghiti, MD
Sub-Investigator: Alain Sauvanet, MD
Service de Chirurgie Digestive - Hôpital Henri Mondor	Recruiting
Créteil, France, 94010
Contact: Daniel Cherqui, MD 33-1-4981-2548 daniel.cherqui@hmn.aphp.fr
Principal Investigator: Daniel Cherqui, MD
Département de Chirurgie Digestive et de l'Urgence - Hôpital Michallon	Recruiting
Grenoble, France, 38043
Contact: Christian Letoublon, MD 33-4-7676-9279 Cletoublon@chu-grenoble.fr
Principal Investigator: Christian Letoublon, MD
Service de Chirurgie Viscérale et Transplantations - Hôpital Dupuytren	Recruiting
Limoges, France, 87042
Contact: Bernard Descottes, MD 33-5-5505-6680 bernard.descottes@unilim.fr
Principal Investigator: Bernard Descottes, MD
Sub-Investigator: Franck Maisonnette, MD
Chirurgie Générale et Digestive - Hôpital de La Croix Rousse	Recruiting
Lyon, France, 69317
Contact: Jacques Beaulieu, MD 33-4-7207-1627 jacques.beaulieu@chu-lyon.fr
Principal Investigator: Jacques Beaulieu, MD
Département de Chirurgie - CRLCC Léon Bérard	Recruiting
Lyon, France, 69008
Contact: Michel Rivoire, MD 33-4-7878-2639 rivoire@lyon.fnclcc.fr
Principal Investigator: Michel Rivoire, MD
Chirurgie I - Institut Paoli Calmettes	Recruiting
Marseille, France, 13273
Contact: Jean-Robert Delpero, MD 33-4-9122-3660 delperojr@marseille.fnclcc.fr
Principal Investigator: Jean-Robert Delpero, MD
Chirurgie Digestive - Hôpital Saint Eloi	Recruiting
Montpellier, France, 34295
Contact: Jean-Michel Fabre, MD 33-4-6733-7097 jm-fabre@chu-montpellier.fr
Principal Investigator: Jean-Michel Fabre, MD
Sub-Investigator: Francis Navarro, MD
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
Chirurgie Viscérale Digestive - CH Chubert	Recruiting
Vannes, France, 70555
Contact: Marc Leclerc du Sablon, MD 33-2-9701-4206 marc.leclerc@ch-bretagne-atlantique.fr
Principal Investigator: Marc Leclerc du Sablon, MD
Chirurgie Générale - Hôpital Archet II	Recruiting
Nice, France, 06202
Contact: André Bourgeon, MD 33-4-9203-6519 bourgeon.a@chu-nice.fr
Principal Investigator: André Bourgeon, MD
Sub-Investigator: Daniel Benchimol, MD
Département de Chirurgie - Hôpital Lariboisière	Recruiting
Paris, France, 75475
Contact: Patrice Valleur, MD 33-1-4995-8257 patrice.valleur@lrb.aphp.fr
Principal Investigator: Patrice Valleur, MD
Sub-Investigator: Yves Panis, MD
Service de Chirurgie Générale et Digestive - Hôpital Cochin	Recruiting
Paris, France, 75679
Contact: Olivier Soubrane, MD 33-1-5841-1723 olivier.soubrane@cch.aphp.fr
Principal Investigator: Olivier Soubrane, MD
Service de Chirurgie - Hôpital Jean Bernard	Recruiting
Poitiers, France, 86021
Contact: Jean-Pierre Richer, MD 33-5-4944-4444 jean-pierre.richer@chu-poitiers.fr
Principal Investigator: Jean-Pierre Richer, MD
Chirurgie Digestive - CH La Beauchée	Recruiting
Saint Brieuc, France, 22023
Contact: Hervé Ollivier, MD 33-2-9601-7032 herve.ollivier@ch-stbrieuc.fr
Principal Investigator: Hervé Ollivier, MD
Sub-Investigator: Agnès Audebert, MD
Sub-Investigator: Serge Hannoun, MD
Sub-Investigator: David Lechaux, MD
Chirurgie Viscérale - CH Saint Malo	Recruiting
Saint Malo, France, 35400
Contact: Alexis Damamme, MD 33-2-9921-2182 a.damamme@ch-stmalo.fr
Principal Investigator: Alexis Damamme, MD
Sub-Investigator: Philippe Thevenet, MD
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
Centre Hépato-biliaire - Hôpital Paul Brousse	Recruiting
Villejuif, France
Contact: René Adam, MD 33-1-4559-3288 rené.adam@pbr.aphp.fr
Principal Investigator: René Adam, MD
Département de Chirurgie - Institut Gustave Roussy	Recruiting
Villejuif, France, 94805
Contact: Dominique Elias, MD 33-1-4211-4045 elias@igr.fr
Principal Investigator: Dominique Elias, MD
Chirurgie Générale et Digestive - Hôpital Ambroise Paré	Recruiting
Boulogne-Billancourt, France, 92100
Contact: Bernard Nordlinger, MD 33-1-4909-5586 bernard.nordlinger@apr.aphp.fr
Principal Investigator: Bernard Nordlinger, MD
Sub-Investigator: Christophe Penna, MD
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
Fédération médico-chirurgicale des maladies de l'appareil digestif	Recruiting
Laval, France, 53015
Contact: Claire Stampfli, MD claire.stampfli@chlaval.fr
Principal Investigator: Claire Stampfli, MD
Centre de Chirurgie et Réanimation Digestives - Hôpital Saint Antoine	Recruiting
Paris, France, 75570
Contact: Rolland Parc, MD 00-1-4928-2545 rolland.parc@sat.aphp.fr
Principal Investigator: Rolland Parc, MD
Sub-Investigator: Mickael Lesurtel, MD
Chirurgie Digestive, Centre Hospitalier de Cornouailles	Recruiting
Quimper, France, 29107
Contact: Jean-Pierre Le Toquart, MD
Principal Investigator: Jean-Pierre Le Toquart, MD
Chirurgie Digestive et Endocrinienne - Hôpital de Trousseau	Recruiting
Tours, France, 37044
Contact: Loïk de Calan, MD 00-2-4747-8614 decalan@med.univ-tours.fr
Principal Investigator: Loïk de Calan, MD
Sub-Investigator: Pascal Bourlier, 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

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Responsible Party:	Rennes University Hospital ( Direction of Clinical Research )
Study ID Numbers:	DGS 2005/0193, PHRC/04-01, CIC0203/030
Study First Received:	December 12, 2005
Last Updated:	August 19, 2009
ClinicalTrials.gov Identifier:	NCT00264979 History of Changes
Health Authority:	France: Direction Générale de la Santé