Clinical trial NCT00212589: Patients Preference for Oral or i.v. Therapy
Official title: A Randomized Crossover Trial Comparing Oral Capecitabine and Intravenous Fluorouracil + Folinic Acid (Nordic FU/FA Regimen) for Patient Preference in Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Cancer
Keywords: Patients preference
Colorectal cancer
Capecitabine
Fluorouracil + folinic acid
Cross-over study
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: Department of Oncology, Esbjerg Hospital
city: Odense
country: Denmark
facility: Department of Oncology, Odense University Hospital
city: Sonderborg
country: Denmark
facility: Department of Oncology, Sonderborg Hospital
city: Vejle
country: Denmark
facility: Department of Oncology, Vejle Hospital
Study officials:
affiliation: Department of Oncology, Odense University Hospital, DK-5000 Odense C, Denmark
name: Per Pfeiffer, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1111/j.1365-2354.2005.00531.x.
citation: 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.