Overview
Patients Preference for Oral or i.v. Therapy
Status:
Completed
Completed
Trial end date:
2004-04-01
2004-04-01
Target enrollment:
0
0
Participant gender:
All
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 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Odense University HospitalTreatments:
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