Patients Preference for Oral or i.v. Therapy

Odense University Hospital

Status and phase

Completed

Phase 3

Conditions

Colorectal Cancer

Treatments

Drug: Fluorouracil + folinic acid

Drug: Capecitabine

Study type

Interventional

Funder types

Other

Identifiers

NCT00212589

11.02

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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