Evaluation of 2 Resection Strategies of Synchronous Colorectal Cancer Metastases

Not Applicable

Terminated

• Conditions: Colorectal Cancer; Hepatic Metastases
• Interventions: Procedure: Sequential surgery; Procedure: Simultaneous surgery

• Registration Number: NCT00264979
• Lead Sponsor: Rennes University Hospital

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.

Study Timeline

• Study First Submitted: 2005-12-12
• Study First Submitted QC: 2005-12-12
• Study First Posted: 2005-12-13
• Study Start: 2006-03-02
• Primary Completion: 2017-12-11
• Study Completion: 2017-12-11
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-08
• Last Update Posted: 2019-03-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 105

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Sequential surgery	Sequential surgeries of colorectal cancer and synchronous liver metastases
1	Simultaneous surgery	Simultaneous surgery of colorectal cancer and synchronous liver metastases

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Death rate during hospitalization or within 60 days after each surgery	60 days after each surgery
Rate and number of severe general, digestive or hepatic complications	2 years after the first surgery
Rate of unachieved hepatic resection	Day of the hepatic surgery
Global survival distribution and 2 years global survival rate	2 years after the first surgery
Recurrence-free survival distribution and 2 years recurrence-free survival rate	2 years
Two years recurrence rate	2 years

Trial Locations

Locations (14)

Département de Chirurgie - CRLCC Léon Bérard; 🇫🇷 Lyon, France

Service de Chirurgie viscérale, digestive et cancérologie - Hôpital Jean Mingoz; 🇫🇷 Besancon, France

Service de Chirurgie - Hôpital Jean Bernard; 🇫🇷 Poitiers, France

Service d'Oncologie Digestive- CRLCC Eugène Marquis; 🇫🇷 Rennes, France

Centre Hépato-biliaire - Hôpital Paul Brousse; 🇫🇷 Villejuif, France

Département de Chirurgie Viscérale - Hôpital Pontchaillou; 🇫🇷 Rennes, France

Chirurgie générale viscérale et digestive - Hôpital Nord; 🇫🇷 Amiens, 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

Chirurgie digestive, thoracique et cancérologie; 🇫🇷 Dijon, France

Chirurgie Viscérale Digestive - CH Chubert; 🇫🇷 Vannes, France

Clinique Chirurgicale A - Hôtel Dieu; 🇫🇷 Nantes, France

Clinique Chirurgicale I - Hôpital Nord; 🇫🇷 Nantes, France

Centre de Chirurgie Viscérale et de Transplantation - CHU de Hautepierre; 🇫🇷 Strasbourg, France