Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00189657
Status:
UNKNOWN
Last Update Posted:
2005-09-19
First Post:
2005-09-12
Brief Title:
5FUVL Vs LV5FU2 CPT11 in Stage II-III Resected Rectal Cancer
Sponsor:
Association Européenne de Recherche en Oncologie
Organization:
Association Européenne de Recherche en Oncologie
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main objective of this randomized trial is to compare 5FULV Mayo-Clinic regimen or LV5FU2 to LV5FU2 irinotécan in patients with resected B2 and C rectal cancer Preoperative radiotherapy is recommended but not mandatory Main endpoint is disease free survival Secondary endpoint are overall survival time to local recurrence time to distant metastases and tolerance A total of 600 patients will be included in the trial
Detailed Description:
None
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