Patients Preference for Oral or i.v. Therapy

• Status: Completed
• Trial end date: 2004-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Odense University Hospital
• Treatments: Capecitabine; Fluorouracil; Folic Acid; Leucovorin; Levoleucovorin

Criteria

Inclusion Criteria:

• Indication for treatment with a FU-regime

• WHO Performance Status 0-1

• Life expectancy > 3 months

• Adequate haematological, renal and hepatic functions

• Adequate contraceptives

• Written informed consent

Exclusion Criteria:

• Known CNS-metastases

• Prior treatment with chemotherapy

• Pregnant or breast feeding women

• Current infection, unresolved bowel obstruction or subobstruction, uncontrolled Crohn's disease or ulcerative colitis

• other serious illness or medical conditions