Patients Preference for Oral or i.v. Therapy

Phase 3

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT00212589
• Lead Sponsor: Odense University Hospital

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

Not available

Study Timeline

• Study Start: 2002-12
• Study Completion: 2004-04
• Status Verified: 2004-05
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Last Update Submitted: 2005-09-13
• Study First Posted: 2005-09-21
• Last Update Posted: 2005-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Trial Locations

Locations (4)

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