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
18 Years
N/A
Both
Colorectal Cancer, Hepatic Metastases
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Rate of patients with at least one postoperative severe complication within 60 days after each surgery
Outcome Time Frame:
60 days after each surgery
Safety Issue:
Yes
Principal Investigator
Karim Boudjema, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
CHU Rennes
Authority:
France: Direction Générale de la Santé
Study ID:
DGS 2005/0193
NCT ID:
NCT00264979
Start Date:
December 2005
Completion Date:
June 2014
Related Keywords:
- Colorectal Cancer
- Hepatic Metastases
- Colorectal cancer
- Sequential or simultaneous surgery
- Synchronous hepatic metastases
- Colorectal Neoplasms
- Neoplasm Metastasis
- Neoplasms, Second Primary
- Liver Neoplasms
Name | Location |
|---|
