Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00212589
Status:
COMPLETED
Last Update Posted:
2005-09-21
First Post:
2005-09-13
Brief Title:
Patients Preference for Oral or iv Therapy
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
Official Title:
A Randomized Crossover Trial Comparing Oral Capecitabine and Intravenous Fluorouracil Folinic Acid Nordic FUFA Regimen for Patient Preference in Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2004-05
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:
Until recently bolus 5-flourouracil FU folinic acid FA has been considered the standard chemotherapy for patients with colorectal cancer Several studies have shown that Capecitabine is as effective as Mayo regimen The Nordic FUFA schedule was developed to be an active and tolerable bolus regimen The Nordic regimen consists of a short 3 minutes bolus injection of FU and 30 minutes later FA for 2 consecutive days each 2 weeks In randomized studies efficacy is comparable to other FUFA regimens
It is claimed that patients prefer oral therapy and in a randomized study comparing oral therapy UFTFA and bolus FUFA Mayo 84 preferred oral therapy
In the present randomized cross-over study patients were randomized for 3 courses of Nordic FUFA followed by 2 courses of Capecitabine or vice versa and patients were asked for their preference
It is claimed that patients prefer oral therapy and in a randomized study comparing oral therapy UFTFA and bolus FUFA Mayo 84 preferred oral therapy
In the present randomized cross-over study patients were randomized for 3 courses of Nordic FUFA followed by 2 courses of Capecitabine or vice versa and patients were asked for their preference
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