Patients Preference for Oral or i.v. Therapy
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 FU/FA 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 FU/FA regimens.
It is claimed that patients prefer oral therapy and in a randomized study comparing oral therapy (UFT/FA) and bolus FU/FA (Mayo) 84% preferred oral therapy.
In the present randomized cross-over study patients were randomized for 3 courses of Nordic FU/FA followed by 2 courses of Capecitabine (or vice versa), and patients were asked for their preference.
|Colorectal Cancer||Drug: Capecitabine Drug: Fluorouracil + folinic acid||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||A Randomized Crossover Trial Comparing Oral Capecitabine and Intravenous Fluorouracil + Folinic Acid (Nordic FU/FA Regimen) for Patient Preference in Colorectal Cancer|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00212589
|Department of Oncology, Esbjerg Hospital|
|Esbjerg, Denmark, 6700|
|Department of Oncology, Odense University Hospital|
|Odense, Denmark, 5000|
|Department of Oncology, Sonderborg Hospital|
|Sonderborg, Denmark, 6400|
|Department of Oncology, Vejle Hospital|
|Vejle, Denmark, 7100|
|Principal Investigator:||Per Pfeiffer, MD||Department of Oncology, Odense University Hospital, DK-5000 Odense C, Denmark|