Evaluation of 2 Resection Strategies of Synchronous Colorectal Cancer Metastases
Conditions
Colorectal Cancer - Hepatic Metastases
Conditions: official terms
Colorectal Neoplasms - Liver Neoplasms - Neoplasm Metastasis
Conditions: Keywords
Colorectal cancer, Sequential or simultaneous surgery, Synchronous hepatic metastases
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Simultaneous surgery Type: Procedure
Name: Sequential surgery Type: Procedure
Overall Status
Recruiting
Summary
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Locations
Chirurgie générale viscérale et digestive - Hôpital Nord
Amiens, France
Status: Recruiting
Chirurgie Viscérale - CHU Angers
Angers, France
Status: Suspended
Service de Chirurgie viscérale, digestive et cancérologie - Hôpital Jean Mingoz
Besancon, France
Status: Recruiting
Contact: Georges Mantion, MD - 33-3-8166-8243 - georges.mantion@ufc-chu.univ-fcompte.fr
Chirurgie Digestive - Hôpital Saint André
Bordeaux, France
Status: Suspended
Chirurgie Générale et Digestive - Hôpital Ambroise Paré
Boulogne-Billancourt, France
Status: Suspended
Chirurgie Générale - CHU La Cavale Blanche
Brest, France
Status: Suspended
Service de Chirurgie Digestive - Hôpital de la Côte de Nacre
Caen, France
Status: Suspended
Chirurgie Digestive - Hôtel Dieu
Clermont-Ferrand, France
Status: Suspended
Service d'Hépatogastroentérologie - Hôpital Beaujon
Clichy, France
Status: Suspended
Service de Chirurgie Digestive - Hôpital Henri Mondor
Créteil, France
Status: Suspended
Chirurgie digestive, thoracique et cancérologie
Dijon, France
Status: Recruiting
Contact: Jean Pierre Favre, MD - 00-3-8029-3401 - jean-pierre.favre@chu-dijon.fr
Département de Chirurgie Digestive et de l'Urgence - Hôpital Michallon
Grenoble, France
Status: Suspended
Fédération médico-chirurgicale des maladies de l'appareil digestif
Laval, France
Status: Suspended
Service de Chirurgie Viscérale et Transplantations - Hôpital Dupuytren
Limoges, France
Status: Suspended
Chirurgie Générale et Digestive - Hôpital de La Croix Rousse
Lyon, France
Status: Suspended
Département de Chirurgie - CRLCC Léon Bérard
Lyon, France
Status: Suspended
Chirurgie I - Institut Paoli Calmettes
Marseille, France
Status: Suspended
Chirurgie Digestive - Hôpital Saint Eloi
Montpellier, France
Status: Suspended
Clinique Chirurgicale A - Hôtel Dieu
Nantes, France
Status: Recruiting
Contact: Jean-Claude Le Neel, MD - 33-2-4008-3041 - jeanclaude.leneel@chu-nantes.fr
Clinique Chirurgicale I - Hôpital Nord
Nantes, France
Status: Recruiting
Contact: Jacques Paineau, MD - 33-2-4016-5055 - jacques.paineau@chu-nantes.fr
Chirurgie Générale - Hôpital Archet II
Nice, France
Status: Suspended
Centre de Chirurgie et Réanimation Digestives - Hôpital Saint Antoine
Paris, France
Status: Suspended
Département de Chirurgie - Hôpital Lariboisière
Paris, France
Status: Suspended
Service de Chirurgie hépato-biliaire et Transplantation Hépatique- Paris Saint Antoine
Paris, France
Status: Suspended
Service de Chirurgie - Hôpital Jean Bernard
Poitiers, France
Status: Suspended
Chirurgie Digestive, Centre Hospitalier de Cornouailles
Quimper, France
Status: Suspended
Département de Chirurgie Viscérale - Hôpital Pontchaillou
Rennes, France
Status: Recruiting
Contact: Karim Boudjema, MD, PhD - 33-2-9928-4265 - karim.boudjema@chu-rennes.fr
Service d'Oncologie Digestive- CRLCC Eugène Marquis
Rennes, France
Status: Recruiting
Contact: Jean-Luc Raoul, MD - 33-2-9925-3172 - raoul@rennes.fnclcc.fr
Chirurgie Digestive - CH La Beauchée
Saint Brieuc, France
Status: Suspended
Chirurgie Viscérale - CH Saint Malo
Saint Malo, France
Status: Suspended
Centre de Chirurgie Viscérale et de Transplantation - CHU de Hautepierre
Strasbourg, France
Status: Recruiting
Contact: Daniel Jaeck, MD - 33-3-8812-7256 - daniel.jaeck@chru-strasbourg.fr
Chirurgie Digestive et Endocrinienne - Hôpital de Trousseau
Tours, France
Status: Suspended
Chirurgie Viscérale Digestive - CH Chubert
Vannes, France
Status: Suspended
Centre Hépato-biliaire - Hôpital Paul Brousse
Villejuif, France
Status: Suspended
Département de Chirurgie - Institut Gustave Roussy
Villejuif, France
Status: Suspended
Start Date
December 2005
Completion Date
December 2015
Sponsors
Rennes University Hospital
Source
Rennes University Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page