Evaluation of 2 Resection Strategies of Synchronous Colorectal Cancer Metastases

Condition(s) targeted: Colorectal Cancer; Hepatic Metastases

Intervention: Simultaneous surgery (Procedure); Sequential surgery (Procedure)

Phase: N/A

Status: Recruiting

Sponsored by: Rennes University Hospital

Official(s) and/or principal investigator(s):
Karim Boudjema, MD, PhD, Principal Investigator, Affiliation: CHU Rennes
Jean-Luc Raoul, MD, Principal Investigator, Affiliation: Centre Eugène Marquis - CRLCC Rennes
Eric Bellissant, MD, PhD, Study Chair, Affiliation: CHU Rennes

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

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.

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

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

Primary outcome: Rate of patients with at least one postoperative severe complication within 60 days after each surgery

Secondary outcome:

Death rate during hospitalization or within 60 days after each surgery

Rate and number of severe general, digestive or hepatic complications

Rate of unachieved hepatic resection

Global survival distribution and 2 years global survival rate

Recurrence-free survival distribution and 2 years recurrence-free survival rate

Two years recurrence rate

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

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

Département de Chirurgie Viscérale - Hôpital Pontchaillou, Rennes 35033, France; Recruiting
Karim Boudjema, MD, PhD, Phone: 33-2-9928-4265, Email: karim.boudjema@chu-rennes.fr
Karim Boudjema, MD, PhD, Principal Investigator
Jean-Pierre Campion, MD, Sub-Investigator
Bernard Meunier, MD, Sub-Investigator

Service d'Oncologie Digestive- CRLCC Eugène Marquis, Rennes 35000, France; Recruiting
Jean-Luc Raoul, MD, Phone: 33-2-9925-3172, Email: raoul@rennes.fnclcc.fr
Jean-Luc Raoul, MD, Principal Investigator

Chirurgie Viscérale - CHU Angers, Angers 49033, France; Recruiting
Jean-Pierre Arnaud, MD, Phone: 33-2-4135-3618, Email: Jparnaud@chu-angers.fr
Jean-Pierre Arnaud, MD, Principal Investigator

Service de Chirurgie viscérale, digestive et cancérologie - Hôpital Jean Mingoz, Besancon 25000, France; Recruiting
Georges Mancion, MD, Phone: 33-3-8166-8243, Email: georges.mancion@ufc-chu.univ-fcompte.fr
Georges Mancion, MD, Principal Investigator
Bruno Heyd, MD, Sub-Investigator

Chirurgie Digestive - Hôpital Saint André, Bordeaux 33075, France; Recruiting
Jean Saric, MD, Phone: 33-5-5679-5810, Email: jean.saric@chu-bordeaux.fr
Jean Saric, MD, Principal Investigator
Christophe Laurent, MD, Sub-Investigator

Chirurgie Générale - CHU La Cavale Blanche, Brest 29609, France; Recruiting
Patrick Lozach, MD, Phone: 33-2-9834-7224, Email: patrick.lozach@wanadoo.fr
Patrick Lozach, MD, Principal Investigator

Service de Chirurgie Digestive - Hôpital de la Côte de Nacre, Caen 14033, France; Recruiting
Philippe Segol, MD, Phone: 33-2-3106-5020, Email: segol.ph@chu-caen.fr
Philippe Segol, MD, Principal Investigator
Laurence Chiche, MD, Sub-Investigator

Chirurgie Digestive - Hôtel Dieu, Clermont-Ferrand 63058, France; Recruiting
Philippe Chipponi, MD, Phone: 33-4-7375-0494, Email: jchipponi@chu-clermontferrand.fr
Philippe Chipponi, MD, Principal Investigator
Karem Slim, MD, Sub-Investigator

Service d'Hépatogastroentérologie - Hôpital Beaujon, Clichy 92110, France; Recruiting
Jacques Belghiti, MD, Phone: 33-1-4087-5895, Email: j.belghiti@bjn.aphp.fr
Jacques Belghiti, MD, Principal Investigator
Alain Sauvanet, MD, Sub-Investigator

Service de Chirurgie Digestive - Hôpital Henri Mondor, Créteil 94010, France; Recruiting
Daniel Cherqui, MD, Phone: 33-1-4981-2548, Email: daniel.cherqui@hmn.aphp.fr
Daniel Cherqui, MD, Principal Investigator

Département de Chirurgie Digestive et de l'Urgence - Hôpital Michallon, Grenoble 38043, France; Recruiting
Christian Letoublon, MD, Phone: 33-4-7676-9279, Email: Cletoublon@chu-grenoble.fr
Christian Letoublon, MD, Principal Investigator

Service de Chirurgie Viscérale et Transplantations - Hôpital Dupuytren, Limoges 87042, France; Recruiting
Bernard Descottes, MD, Phone: 33-5-5505-6680, Email: bernard.descottes@unilim.fr
Bernard Descottes, MD, Principal Investigator
Franck Maisonnette, MD, Sub-Investigator

Chirurgie Générale et Digestive - Hôpital de La Croix Rousse, Lyon 69317, France; Recruiting
Jacques Beaulieu, MD, Phone: 33-4-7207-1627, Email: jacques.beaulieu@chu-lyon.fr
Jacques Beaulieu, MD, Principal Investigator

Département de Chirurgie - CRLCC Léon Bérard, Lyon 69008, France; Recruiting
Michel Rivoire, MD, Phone: 33-4-7878-2639, Email: rivoire@lyon.fnclcc.fr
Michel Rivoire, MD, Principal Investigator

Chirurgie I - Institut Paoli Calmettes, Marseille 13273, France; Recruiting
Jean-Robert Delpero, MD, Phone: 33-4-9122-3660, Email: delperojr@marseille.fnclcc.fr
Jean-Robert Delpero, MD, Principal Investigator

Chirurgie Digestive - Hôpital Saint Eloi, Montpellier 34295, France; Recruiting
Jean-Michel Fabre, MD, Phone: 33-4-6733-7097, Email: jm-fabre@chu-montpellier.fr
Jean-Michel Fabre, MD, Principal Investigator
Francis Navarro, MD, Sub-Investigator

Clinique Chirurgicale I - Hôpital Nord, Nantes 44093, France; Recruiting
Jacques Paineau, MD, Phone: 33-2-4016-5055, Email: jacques.paineau@chu-nantes.fr
Jacques Paineau, MD, Principal Investigator

Clinique Chirurgicale A - Hôtel Dieu, Nantes 44093, France; Recruiting
Jean-Claude Le Neel, MD, Phone: 33-2-4008-3041, Email: jeanclaude.leneel@chu-nantes.fr
Jean-Claude Le Neel, MD, Principal Investigator
Paul-Antoine Lehur, MD, Sub-Investigator

Chirurgie Générale - Hôpital Archet II, Nice 06202, France; Recruiting
André Bourgeon, MD, Phone: 33-4-9203-6519, Email: bourgeon.a@chu-nice.fr
André Bourgeon, MD, Principal Investigator
Daniel Benchimol, MD, Sub-Investigator

Département de Chirurgie - Hôpital Lariboisière, Paris 75475, France; Recruiting
Patrice Valleur, MD, Phone: 33-1-4995-8257, Email: patrice.valleur@lrb.aphp.fr
Patrice Valleur, MD, Principal Investigator
Yves Panis, MD, Sub-Investigator

Service de Chirurgie Générale et Digestive - Hôpital Cochin, Paris 75679, France; Recruiting
Olivier Soubrane, MD, Phone: 33-1-5841-1723, Email: olivier.soubrane@cch.aphp.fr
Olivier Soubrane, MD, Principal Investigator

Service de Chirurgie - Hôpital Jean Bernard, Poitiers 86021, France; Recruiting
Jean-Pierre Richer, MD, Phone: 33-5-4944-4444, Email: jean-pierre.richer@chu-poitiers.fr
Jean-Pierre Richer, MD, Principal Investigator

Chirurgie Digestive - CH La Beauchée, Saint Brieuc 22023, France; Recruiting
Hervé Ollivier, MD, Phone: 33-2-9601-7032, Email: herve.ollivier@ch-stbrieuc.fr
Hervé Ollivier, MD, Principal Investigator
Agnès Audebert, MD, Sub-Investigator
Serge Hannoun, MD, Sub-Investigator
David Lechaux, MD, Sub-Investigator

Chirurgie Viscérale - CH Saint Malo, Saint Malo 35400, France; Recruiting
Alexis Damamme, MD, Phone: 33-2-9921-2182, Email: a.damamme@ch-stmalo.fr
Alexis Damamme, MD, Principal Investigator
Philippe Thevenet, MD, Sub-Investigator

Centre de Chirurgie Viscérale et de Transplantation - CHU de Hautepierre, Strasbourg 67098, France; Recruiting
Daniel Jaeck, MD, Phone: 33-3-8812-7256, Email: daniel.jaeck@chru-strasbourg.fr
Daniel Jaeck, MD, Principal Investigator
Elie Oussoultzoglou, MD, Sub-Investigator

Centre Hépato-biliaire - Hôpital Paul Brousse, Villejuif, France; Recruiting
René Adam, MD, Phone: 33-1-4559-3288, Email: rené.adam@pbr.aphp.fr
René Adam, MD, Principal Investigator

Département de Chirurgie - Institut Gustave Roussy, Villejuif 94805, France; Recruiting
Dominique Elias, MD, Phone: 33-1-4211-4045, Email: elias@igr.fr
Dominique Elias, MD, Principal Investigator

Chirurgie Générale et Digestive - Hôpital Ambroise Paré, Boulogne-Billancourt 92100, France; Recruiting
Bernard Nordlinger, MD, Phone: 33-1-4909-5586, Email: bernard.nordlinger@apr.aphp.fr
Bernard Nordlinger, MD, Principal Investigator
Christophe Penna, MD, Sub-Investigator

Chirurgie digestive, thoracique et cancérologie, Dijon 21000, France; Recruiting
Jean Pierre Favre, MD, Phone: 00-3-8029-3401, Email: jean-pierre.favre@chu-dijon.fr
Jean-Pierre Favre, MD, Principal Investigator
Patrick Rat, MD, Sub-Investigator

Fédération médico-chirurgicale des maladies de l'appareil digestif, Laval 53015, France; Recruiting
Claire Stampfli, MD, Email: claire.stampfli@chlaval.fr
Claire Stampfli, MD, Principal Investigator

Centre de Chirurgie et Réanimation Digestives - Hôpital Saint Antoine, Paris 75570, France; Recruiting
Rolland Parc, MD, Phone: 00-1-4928-2545, Email: rolland.parc@sat.aphp.fr
Rolland Parc, MD, Principal Investigator
Mickael Lesurtel, MD, Sub-Investigator

Chirurgie Digestive, Centre Hospitalier de Cornouailles, Quimper 29107, France; Recruiting
Jean-Pierre Le Toquart, MD
Jean-Pierre Le Toquart, MD, Principal Investigator

Chirurgie Digestive et Endocrinienne - Hôpital de Trousseau, Tours 37044, France; Recruiting
Loïk de Calan, MD, Phone: 00-2-4747-8614, Email: decalan@med.univ-tours.fr
Loïk de Calan, MD, Principal Investigator
Pascal Bourlier, MD, Sub-Investigator

Chirurgie Viscérale Digestive - CH Chubert, Vannes 70555, France; Recruiting
Marc Leclerc du Sablon, MD, Phone: 33-2-9701-4206, Email: marc.leclerc@ch-bretagne-atlantique.fr
Marc Leclerc du Sablon, MD, Principal Investigator

Related 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.

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.

Starting date: December 2005
Last updated: August 19, 2009