Evaluation of 2 Resection Strategies of Synchronous Colorectal Cancer Metastases

Colorectal Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00264979
• Other study ID #: DGS 2005/0193
• Secondary ID: PHRC/04-01CIC020
• Status: Terminated
• Phase: N/A
• Start date: March 2, 2006
• Est. completion date: December 11, 2017

Study information

• Verified date: March 2019
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 105
• Est. completion date: December 11, 2017
• Est. primary completion date: December 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Hepatic Metastases
• Liver Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

Procedure:
• Simultaneous surgery
Simultaneous surgery of colorectal cancer and synchronous liver metastases
• 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.

Locations

Country	Name	City	State
France	Chirurgie générale viscérale et digestive - Hôpital Nord	Amiens
France	Service de Chirurgie viscérale, digestive et cancérologie - Hôpital Jean Mingoz	Besancon
France	Chirurgie digestive, thoracique et cancérologie	Dijon
France	Département de Chirurgie - CRLCC Léon Bérard	Lyon
France	Clinique Chirurgicale A - Hôtel Dieu	Nantes
France	Clinique Chirurgicale I - Hôpital Nord	Nantes
France	Centre de Chirurgie et Réanimation Digestives - Hôpital Saint Antoine	Paris
France	Service de Chirurgie hépato-biliaire et Transplantation Hépatique- Paris Saint Antoine	Paris
France	Service de Chirurgie - Hôpital Jean Bernard	Poitiers
France	Département de Chirurgie Viscérale - Hôpital Pontchaillou	Rennes
France	Service d'Oncologie Digestive- CRLCC Eugène Marquis	Rennes
France	Centre de Chirurgie Viscérale et de Transplantation - CHU de Hautepierre	Strasbourg
France	Chirurgie Viscérale Digestive - CH Chubert	Vannes
France	Centre Hépato-biliaire - Hôpital Paul Brousse	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
Rennes University Hospital	Ministry of Health, France

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients with at least one postoperative severe complication within 60 days after each surgery		60 days after each surgery
Secondary	Death rate during hospitalization or within 60 days after each surgery		60 days after each surgery
Secondary	Rate and number of severe general, digestive or hepatic complications		2 years after the first surgery
Secondary	Rate of unachieved hepatic resection		Day of the hepatic surgery
Secondary	Global survival distribution and 2 years global survival rate		2 years after the first surgery
Secondary	Recurrence-free survival distribution and 2 years recurrence-free survival rate		2 years
Secondary	Two years recurrence rate		2 years