Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00174616
Status:
COMPLETED
Last Update Posted:
2009-12-07
First Post:
2005-09-09
Brief Title:
CORE Capecitabine Oxaliplatin Radiotherapy and Excision
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Phase 2 Study of Weekly Oxaliplatin and Capecitabine XELOX in Combination With Preoperative Radiotherapy in Patients With MRI Defined Locally Advanced Rectal Cancer
Status:
COMPLETED
Status Verified Date:
2009-12
Last Known Status:
None
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:
Primary objective
Pathological complete response ypT0N0 rate
Secondary objectives
Histopathological R0 resection rate
Pathological downstaging ypT0-T2N0 rate
One month surgical complication rate
Predictive value of pre-operative MRI for surgical pathological and clinical outcomes
Safety
Local and distant recurrence rates
Progression-free survival
Overall survival
Pathological complete response ypT0N0 rate
Secondary objectives
Histopathological R0 resection rate
Pathological downstaging ypT0-T2N0 rate
One month surgical complication rate
Predictive value of pre-operative MRI for surgical pathological and clinical outcomes
Safety
Local and distant recurrence rates
Progression-free survival
Overall survival
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