Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00264979
Status:
TERMINATED
Last Update Posted:
2019-03-11
First Post:
2005-12-12
Brief Title:
Evaluation of 2 Resection Strategies of Synchronous Colorectal Cancer Metastases
Sponsor:
Rennes University Hospital
Organization:
Rennes University Hospital
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Stop recommended following the last sequential analysis
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
METASYNC
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 efficacysafety 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CIC0203030 | None | None | None |
| PHRC04-01 | None | None | None |