Clinical trial NCT00264979: Evaluation of 2 Resection Strategies of Synchronous Colorectal Cancer Metastases
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colorectal Cancer
Hepatic Metastases
Keywords: Colorectal cancer
Sequential or simultaneous surgery
Synchronous hepatic metastases
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2005-12-13
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Rate of patients with at least one postoperative severe complication within 60 days after each surgery
timeFrame: 60 days after each surgery
Secondary outcomes:
measure: Death rate during hospitalization or within 60 days after each surgery
timeFrame: 60 days after each surgery
measure: Rate and number of severe general, digestive or hepatic complications
timeFrame: 2 years after the first surgery
measure: Rate of unachieved hepatic resection
timeFrame: Day of the hepatic surgery
measure: Global survival distribution and 2 years global survival rate
timeFrame: 2 years after the first surgery
measure: Recurrence-free survival distribution and 2 years recurrence-free survival rate
timeFrame: 2 years
measure: Two years recurrence rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Amiens
country: France
facility: Chirurgie générale viscérale et digestive - Hôpital Nord
city: Besancon
country: France
facility: Service de Chirurgie viscérale, digestive et cancérologie - Hôpital Jean Mingoz
city: Dijon
country: France
facility: Chirurgie digestive, thoracique et cancérologie
city: Lyon
country: France
facility: Département de Chirurgie - CRLCC Léon Bérard
city: Nantes
country: France
facility: Clinique Chirurgicale A - Hôtel Dieu
city: Nantes
country: France
facility: Clinique Chirurgicale I - Hôpital Nord
city: Paris
country: France
facility: Centre de Chirurgie et Réanimation Digestives - Hôpital Saint Antoine
city: Paris
country: France
facility: Service de Chirurgie hépato-biliaire et Transplantation Hépatique- Paris Saint Antoine
city: Poitiers
country: France
facility: Service de Chirurgie - Hôpital Jean Bernard
city: Rennes
country: France
facility: Service d'Oncologie Digestive- CRLCC Eugène Marquis
city: Rennes
country: France
facility: Département de Chirurgie Viscérale - Hôpital Pontchaillou
city: Strasbourg
country: France
facility: Centre de Chirurgie Viscérale et de Transplantation - CHU de Hautepierre
city: Vannes
country: France
facility: Chirurgie Viscérale Digestive - CH Chubert
city: Villejuif
country: France
facility: Centre Hépato-biliaire - Hôpital Paul Brousse
Study officials:
affiliation: CHU Rennes
name: Karim Boudjema, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Eugène Marquis - CRLCC Rennes
name: Jean-Luc Raoul, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Rennes
name: Eric Bellissant, MD, PhD
role: STUDY_CHAIR
References:
citation: Martin R, Paty P, Fong Y, Grace A, Cohen A, DeMatteo R, Jarnagin W, Blumgart L. Simultaneous liver and colorectal resections are safe for synchronous colorectal liver metastasis. J Am Coll Surg. 2003 Aug;197(2):233-41; discussion 241-2. doi: 10.1016/S1072-7515(03)00390-9.
citation: Weber JC, Bachellier P, Oussoultzoglou E, Jaeck D. Simultaneous resection of colorectal primary tumour and synchronous liver metastases. Br J Surg. 2003 Aug;90(8):956-62. doi: 10.1002/bjs.4132.