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CompletedNCT00212589Updated Sep 21, 2005

Patients Preference for Oral or i.v. Therapy

A Phase 3 interventional study of Capecitabine and Fluorouracil + folinic acid in Colorectal Cancer, sponsored by Odense University Hospital. Completed at 4 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-09-21.

Sponsored by Odense University Hospital · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Colorectal Cancer

Keywords

  • Patients preference
  • Colorectal cancer
  • Capecitabine
  • Fluorouracil + folinic acid
  • Cross-over study
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 60 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Odense University Hospital is the lead sponsor of 468 studies on the registry; 109 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double
Enrollment
60 participants

Interventions

  • DrugCapecitabine
  • DrugFluorouracil + folinic acid
06

Study locations

4 sites
  • Department of Oncology, Esbjerg Hospital
    Esbjerg, 6700, Denmark
  • Department of Oncology, Odense University Hospital
    Odense, 5000, Denmark
  • Department of Oncology, Sonderborg Hospital
    Sonderborg, 6400, Denmark
  • Department of Oncology, Vejle Hospital
    Vejle, 7100, Denmark
07

References and documents

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. PubMed 15842464 ↗
  • 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. PubMed 11818199 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00212589
Lead sponsor
Odense University Hospital
First posted
Sep 21, 2005
Start date
Dec 2002
Completion
Apr 2004
Last update
Sep 21, 2005

Study contacts

Per Pfeiffer, MD
principal investigator · Department of Oncology, Odense University Hospital, DK-5000 Odense C, Denmark
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2004. You cannot join it, but the record below documents what was studied.

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