Patients Preference for Oral or i.v. Therapy
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|ClinicalTrials.gov Identifier: NCT00212589|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : September 21, 2005
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: Capecitabine Drug: Fluorouracil + folinic acid||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||A Randomized Crossover Trial Comparing Oral Capecitabine and Intravenous Fluorouracil + Folinic Acid (Nordic FU/FA Regimen) for Patient Preference in Colorectal Cancer|
|Study Start Date :||December 2002|
|Study Completion Date :||April 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|