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

Rennes University Hospital

Status

Terminated

Conditions

Hepatic Metastases

Colorectal Cancer

Treatments

Procedure: Simultaneous surgery

Procedure: Sequential surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT00264979

DGS 2005/0193

PHRC/04-01

CIC0203/030

Details and patient eligibility

About

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.

Full 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.

Enrollment

105 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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