Patients Preference for Oral or i.v. Therapy

Colorectal Cancer Clinical Trial

Official title:

A Randomized Crossover Trial Comparing Oral Capecitabine and Intravenous Fluorouracil + Folinic Acid (Nordic FU/FA Regimen) for Patient Preference in Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00212589
• Other study ID #: 11.02
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: September 13, 2005
• Start date: December 2002
• Est. completion date: April 2004

Study information

• Verified date: May 2004
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Capecitabine

• Fluorouracil + folinic acid

Locations

Country	Name	City	State
Denmark	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

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

Borner MM, Schoffski P, de Wit R, Caponigro F, Comella G, Sulkes A, Greim G, Peters GJ, van der Born K, Wanders J, de Boer RF, Martin C, Fumoleau P. Patient preference and pharmacokinetics of oral modulated UFT versus intravenous fluorouracil and leucovorin: a randomised crossover trial in advanced colorectal cancer. Eur J Cancer. 2002 Feb;38(3):349-58. — View Citation

Lima AP, del Giglio A. Randomized crossover trial of intravenous 5-FU versus oral UFT both modulated by leucovorin: a one-centre experience. Eur J Cancer Care (Engl). 2005 May;14(2):151-4. — View Citation