Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00502671
Status:
COMPLETED
Last Update Posted:
2015-09-03
First Post:
2007-07-17
Brief Title:
A Study of Xeloda Capecitabine as Adjuvant Monotherapy in Patients With Colon Cancer
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
An Open Label Study to Evaluate the Safety of Xeloda as Adjuvant Monotherapy in Patients Who Have Undergone Surgery for Colon Cancer Dukes Stage C
Status:
COMPLETED
Status Verified Date:
2015-08
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:
This single arm study will evaluate the safety profile of Xeloda as monotherapy for adjuvant treatment of colon cancer All patients will receive Xeloda 1250mgm2 po twice daily as intermittent treatment 3 week cycles consisting of 2 weeks of treatment followed by 1 week without treatment The anticipated time on study treatment is 3-12 months and the target sample size is 500 individuals
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