The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: 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 ID: NCT00264979
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Chirurgie générale viscérale et digestive - Hôpital Nord, Amiens, , France
Service de Chirurgie viscérale, digestive et cancérologie - Hôpital Jean Mingoz, Besancon, , France
Chirurgie digestive, thoracique et cancérologie, Dijon, , France
Département de Chirurgie - CRLCC Léon Bérard, Lyon, , France
Clinique Chirurgicale A - Hôtel Dieu, Nantes, , France
Clinique Chirurgicale I - Hôpital Nord, Nantes, , France
Centre de Chirurgie et Réanimation Digestives - Hôpital Saint Antoine, Paris, , France
Service de Chirurgie hépato-biliaire et Transplantation Hépatique- Paris Saint Antoine, Paris, , France
Service de Chirurgie - Hôpital Jean Bernard, Poitiers, , France
Service d'Oncologie Digestive- CRLCC Eugène Marquis, Rennes, , France
Département de Chirurgie Viscérale - Hôpital Pontchaillou, Rennes, , France
Centre de Chirurgie Viscérale et de Transplantation - CHU de Hautepierre, Strasbourg, , France
Chirurgie Viscérale Digestive - CH Chubert, Vannes, , France
Centre Hépato-biliaire - Hôpital Paul Brousse, Villejuif, , France
Name: Karim Boudjema, MD, PhD
Affiliation: CHU Rennes
Role: PRINCIPAL_INVESTIGATOR
Name: Jean-Luc Raoul, MD
Affiliation: Centre Eugène Marquis - CRLCC Rennes
Role: PRINCIPAL_INVESTIGATOR
Name: Eric Bellissant, MD, PhD
Affiliation: CHU Rennes
Role: STUDY_CHAIR