Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00009737
Status:
COMPLETED
Last Update Posted:
2016-06-22
First Post:
2001-02-02
Brief Title:
A Study of Xeloda Capecitabine Compared With 5-Fluorouracil in Combination With Low-Dose Leucovorin in Patients Who Have Undergone Surgery for Colon Cancer
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
An Open-Label Randomized Phase III Study Comparing Xeloda Capecitabine With IV Bolus 5-Fluorouracil in Combination With Low-Dose Leucovorin as Adjuvant Chemotherapy in Patients Who Underwent Surgery for Dukes C Colon Cancer
Status:
COMPLETED
Status Verified Date:
2016-05
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 2 arm study will compare the safety and efficacy of oral Xeloda or 5-fluorouracil in combination with leucovorin in patients who have undergone surgery for colon cancer Patients will be randomized to receive either Xeloda 1250mgm2 po bid on days 1-14 every 21 days or leucovorin 20mgm2 iv 5-fluorouracil 425mgm2 iv daily from day 1 to day 5 every 28 days 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