Colorectal Cancer
Conditions
Keywords
Patients preference, Colorectal cancer, Capecitabine, Fluorouracil + folinic acid, Cross-over study
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.
Interventions
DRUGCapecitabine
DRUGFluorouracil + folinic acid
Sponsors
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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
Countries
Denmark
Outcome results
None listed