Overview

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