Evaluation of 2 Resection Strategies of Synchronous Colorectal Cancer Metastases

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Colorectal Cancer, Hepatic Metastases

Intervention / Treatment
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* Procedure: Simultaneous surgery
* Procedure: Sequential surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Simultaneous surgery of colorectal cancer and synchronous liver metastases | Procedure: Simultaneous surgery<br>* Simultaneous surgery of colorectal cancer and synchronous liver metastases<br>|
| Other: 2<br>Sequential surgeries of colorectal cancer and synchronous liver metastases | Procedure: Sequential surgery<br>* Sequential surgeries of colorectal cancer and synchronous liver metastases: the metastases surgery will be programmed 12 to 14 weeks after the primary tumour exeresis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients with at least one postoperative severe complication within 60 days after each surgery |  | 60 days after each surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal cancer, Sequential or simultaneous surgery, Synchronous hepatic metastases