Colorectal Cancer, Hepatic Metastases
Conditions
Keywords
Colorectal cancer, Sequential or simultaneous surgery, Synchronous hepatic metastases
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.
Interventions
PROCEDURESimultaneous surgery
Simultaneous surgery of colorectal cancer and synchronous liver metastases
PROCEDURESequential 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.
Sponsors
Ministry of Health, France
Rennes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of patients with at least one postoperative severe complication within 60 days after each surgery | 60 days after each surgery |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Death rate during hospitalization or within 60 days after each surgery | 60 days after each surgery |
| Recurrence-free survival distribution and 2 years recurrence-free survival rate | 2 years |
| Two years recurrence rate | 2 years |
| Global survival distribution and 2 years global survival rate | 2 years after the first surgery |
Countries
France
Outcome results
None listed