Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00421824
Status:
COMPLETED
Last Update Posted:
2011-01-04
First Post:
2007-01-11
Brief Title:
Study of Neoadjuvant Chemotherapeutic Treatment XELOX Followed by Chemoradiotherapy XELOXRT and Surgery Versus Chemoradiotherapy Followed by Surgery and Chemotherapy in Patients With High Risk Rectal Cancer
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Phase II Randomized Trial of Neoadjuvant Chemotherapeutic Treatment XELOX Followed by Chemoradiotherapy XELOXRT and Surgery Versus Chemoradiotherapy Followed by Surgery and Chemotherapy in Patients With High Risk Rectal Cancer
Status:
COMPLETED
Status Verified Date:
2011-01
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
To assess complete pathological response rate of both strategies
Secondary
Safety profile
To assess downstaging rate of both strategies
To compare relative dose intensity of oxaliplatin and capecitabine of both strategies
To compare time to progression and overall survival of both strategies
To assess complete pathological response rate of both strategies
Secondary
Safety profile
To assess downstaging rate of both strategies
To compare relative dose intensity of oxaliplatin and capecitabine of both strategies
To compare time to progression and overall survival of both strategies
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT 2005-005149-20 | None | None | None |