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Brief Title: Patients Preference for Oral or i.v. Therapy
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 ID: NCT00212589
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 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Department of Oncology, Esbjerg Hospital, Esbjerg, , Denmark
Department of Oncology, Odense University Hospital, Odense, , Denmark
Department of Oncology, Sonderborg Hospital, Sonderborg, , Denmark
Department of Oncology, Vejle Hospital, Vejle, , Denmark
Name: Per Pfeiffer, MD
Affiliation: Department of Oncology, Odense University Hospital, DK-5000 Odense C, Denmark
Role: PRINCIPAL_INVESTIGATOR