Patients Preference for Oral or i.v. Therapy

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Capecitabine; Drug: Fluorouracil + folinic acid

• Study Type: Interventional
• Enrollment: 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Esbjerg, Denmark, 6700
    • Department of Oncology, Esbjerg Hospital
  • Odense, Denmark, 5000
    • Department of Oncology, Odense University Hospital
  • Sonderborg, Denmark, 6400
    • Department of Oncology, Sonderborg Hospital
  • Vejle, Denmark, 7100
    • Department of Oncology, Vejle Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Investigators: Principal Investigator: Per Pfeiffer, MD, Department of Oncology, Odense University Hospital, DK-5000 Odense C, Denmark

Publications and helpful links

General Publications

• 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. doi: 10.1111/j.1365-2354.2005.00531.x.
• 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. doi: 10.1016/s0959-8049(01)00371-9.

Study record dates

Study Major Dates

• Study Start: December 1, 2002
• Study Completion: April 1, 2004

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 21, 2005

Study Record Updates

• Last Update Posted (Estimate): September 21, 2005
• Last Update Submitted That Met QC Criteria: September 13, 2005
• Last Verified: May 1, 2004

More Information

Terms related to this study

• Keywords: Capecitabine; Colorectal cancer; Cross-over study; Fluorouracil + folinic acid; Patients preference
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Protective Agents; Micronutrients; Vitamins; Antidotes; Vitamin B Complex; Hematinics; Fluorouracil; Capecitabine; Leucovorin; Levoleucovorin; Folic Acid
• Other Study ID Numbers: 11.02