Patients Preference for Oral or i.v. Therapy

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Oncology, Esbjerg Hospital, Esbjerg, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Capecitabine

Drug

Fluorouracil + folinic acid

Drug

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study title

A Randomized Crossover Trial Comparing Oral Capecitabine and Intravenous Fluorouracil + Folinic Acid (Nordic FU/FA Regimen) for Patient Preference in Colorectal Cancer

Important dates

Study start: 2002
Study completion: 2004
First posted: Sep 21, 2005
Registry last updated: Sep 21, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed