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

Primary Purpose

Colorectal Cancer, Hepatic Metastases

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Simultaneous surgery
Sequential surgery
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Colorectal cancer, Sequential or simultaneous surgery, Synchronous hepatic metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chirurgie générale viscérale et digestive - Hôpital Nord
  • Service de Chirurgie viscérale, digestive et cancérologie - Hôpital Jean Mingoz
  • Chirurgie digestive, thoracique et cancérologie
  • Département de Chirurgie - CRLCC Léon Bérard
  • Clinique Chirurgicale A - Hôtel Dieu
  • Clinique Chirurgicale I - Hôpital Nord
  • Centre de Chirurgie et Réanimation Digestives - Hôpital Saint Antoine
  • Service de Chirurgie hépato-biliaire et Transplantation Hépatique- Paris Saint Antoine
  • Service de Chirurgie - Hôpital Jean Bernard
  • Service d'Oncologie Digestive- CRLCC Eugène Marquis
  • Département de Chirurgie Viscérale - Hôpital Pontchaillou
  • Centre de Chirurgie Viscérale et de Transplantation - CHU de Hautepierre
  • Chirurgie Viscérale Digestive - CH Chubert
  • Centre Hépato-biliaire - Hôpital Paul Brousse

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

1

2

Arm Description

Simultaneous surgery of colorectal cancer and synchronous liver metastases

Sequential surgeries of colorectal cancer and synchronous liver metastases

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 12, 2005
Last Updated
March 8, 2019
Sponsor
Rennes University Hospital
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT00264979
Brief Title
Evaluation of 2 Resection Strategies of Synchronous Colorectal Cancer Metastases
Acronym
METASYNC
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 Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
Stop recommended following the last sequential analysis
Study Start Date
March 2, 2006 (Actual)
Primary Completion Date
December 11, 2017 (Actual)
Study Completion Date
December 11, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
Collaborators
Ministry of Health, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Hepatic Metastases
Keywords
Colorectal cancer, Sequential or simultaneous surgery, Synchronous hepatic metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
Simultaneous surgery of colorectal cancer and synchronous liver metastases
Arm Title
2
Arm Type
Other
Arm Description
Sequential surgeries of colorectal cancer and synchronous liver metastases
Intervention Type
Procedure
Intervention Name(s)
Simultaneous surgery
Intervention Description
Simultaneous surgery of colorectal cancer and synchronous liver metastases
Intervention Type
Procedure
Intervention Name(s)
Sequential surgery
Intervention Description
Sequential surgeries of colorectal cancer and synchronous liver metastases: the metastases surgery will be programmed 12 to 14 weeks after the primary tumour exeresis.
Primary Outcome Measure Information:
Title
Rate of patients with at least one postoperative severe complication within 60 days after each surgery
Time Frame
60 days after each surgery
Secondary Outcome Measure Information:
Title
Death rate during hospitalization or within 60 days after each surgery
Time Frame
60 days after each surgery
Title
Rate and number of severe general, digestive or hepatic complications
Time Frame
2 years after the first surgery
Title
Rate of unachieved hepatic resection
Time Frame
Day of the hepatic surgery
Title
Global survival distribution and 2 years global survival rate
Time Frame
2 years after the first surgery
Title
Recurrence-free survival distribution and 2 years recurrence-free survival rate
Time Frame
2 years
Title
Two years recurrence rate
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karim Boudjema, MD, PhD
Organizational Affiliation
CHU Rennes
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean-Luc Raoul, MD
Organizational Affiliation
Centre Eugène Marquis - CRLCC Rennes
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric Bellissant, MD, PhD
Organizational Affiliation
CHU Rennes
Official's Role
Study Chair
Facility Information:
Facility Name
Chirurgie générale viscérale et digestive - Hôpital Nord
City
Amiens
ZIP/Postal Code
80080
Country
France
Facility Name
Service de Chirurgie viscérale, digestive et cancérologie - Hôpital Jean Mingoz
City
Besancon
ZIP/Postal Code
25000
Country
France
Facility Name
Chirurgie digestive, thoracique et cancérologie
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Département de Chirurgie - CRLCC Léon Bérard
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Clinique Chirurgicale A - Hôtel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Clinique Chirurgicale I - Hôpital Nord
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Centre de Chirurgie et Réanimation Digestives - Hôpital Saint Antoine
City
Paris
ZIP/Postal Code
75570
Country
France
Facility Name
Service de Chirurgie hépato-biliaire et Transplantation Hépatique- Paris Saint Antoine
City
Paris
Country
France
Facility Name
Service de Chirurgie - Hôpital Jean Bernard
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Service d'Oncologie Digestive- CRLCC Eugène Marquis
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
Département de Chirurgie Viscérale - Hôpital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Centre de Chirurgie Viscérale et de Transplantation - CHU de Hautepierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Chirurgie Viscérale Digestive - CH Chubert
City
Vannes
ZIP/Postal Code
70555
Country
France
Facility Name
Centre Hépato-biliaire - Hôpital Paul Brousse
City
Villejuif
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
12892803
Citation
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. doi: 10.1016/S1072-7515(03)00390-9.
Results Reference
background
PubMed Identifier
12905548
Citation
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. doi: 10.1002/bjs.4132.
Results Reference
background

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Evaluation of 2 Resection Strategies of Synchronous Colorectal Cancer Metastases

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