Patients Preference for Oral or i.v. Therapy

NCT00212589 | Completed Phase 3

• 1 other identifier: 11.02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

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.

Conditions

Colorectal Cancer

Keywords

Patients preference; Colorectal cancer; Capecitabine; Fluorouracil + folinic acid; Cross-over study

Interventions

Capecitabine DRUG

Fluorouracil + folinic acid DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (4)

Department of Oncology, Esbjerg Hospital

Esbjerg, 6700, Denmark

Location

Department of Oncology, Odense University Hospital

Odense, 5000, Denmark

Location

Department of Oncology, Sonderborg Hospital

Sønderborg, 6400, Denmark

Location

Department of Oncology, Vejle Hospital

Vejle, 7100, Denmark

Location

Related Publications (2)

• 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.

  PMID: 15842464 BACKGROUND

• 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.

  PMID: 11818199 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Capecitabine; Fluorouracil; Leucovorin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Per Pfeiffer, MD

  Department of Oncology, Odense University Hospital, DK-5000 Odense C, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: December 1, 2002
• Study Completion: April 1, 2004
• Last Updated: September 21, 2005

Record last verified: 2004-05

Locations

DK (4)