Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00069121
Status:
COMPLETED
Last Update Posted:
2020-03-06
First Post:
2003-09-15
Brief Title:
A Study of Xeloda Capecitabine Plus Oxaliplatin in Patients With Colon Cancer
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
An Open-Label Randomized Phase III Study of Intermittent Oral Capecitabine in Combination With Intravenous Oxaliplatin Q3W XELOX Versus FluorouracilLeucovorin as Adjuvant Therapy for Patients Who Have Undergone Surgery for Colon Carcinoma AJCCUICC Stage III Dukes Stage C
Status:
COMPLETED
Status Verified Date:
2020-02
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 efficacy and safety of intermittent oral Xeloda plus Eloxatin oxaliplatin with that of fluorouracilleucovorin in patients who have had surgery for colon cancer and no previous chemotherapy Patients will be randomized to receive either 1 XELOX Xeloda 1000mgm2 po bid on days 1-15 oxaliplatin in 3 week cycles or 25-fluorouracil leucovorin in 4 or 8 week cycles The anticipated time on study treatment is until disease progression 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