drugset / Trial / NCT00212589

Patients Preference for Oral or i.v. Therapy

NCT00212589 ↗

Phase 3 Completed 60 enrolled Odense University Hospital
RandomizedCrossoverDouble-blindTreatment

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.

Timeline

Start
2002-12
Primary completion
—
Completion
2004-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule — Oral
Subject Leucovorin Small molecule — Intravenous
Subject fluorouracil Small molecule — Intravenous

Indications