Evaluation of 2 Resection Strategies of Synchronous Colorectal Cancer Metastases (METASYNC)
This study is currently recruiting participants.
Verified February 2013 by Rennes University Hospital
Sponsor:
Rennes University Hospital
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT00264979
First received: December 12, 2005
Last updated: February 5, 2013
Last verified: February 2013
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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 2014 |
| Estimated Primary Completion Date: | December 2013 (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
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: | February 5, 2013 |
| 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:
|
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 |
ClinicalTrials.gov processed this record on May 21, 2013