Contact information
Type
Scientific
Primary contact
Ms V A Walker
ORCID ID
Contact details
Department of Medical Oncology
Level 4
Gledhow Wing
St James's University Hospital
Leeds
LS9 7TF
United Kingdom
+44 (0)113 243 3144
r&d@leedsth.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0436118084
Study information
Scientific title
A comparative pharmacokinetic study: 5 Fluorouracil (5FU) provided as patient specific individual doses and as standard doses according to a 'dose banding' principle
Acronym
Study hypothesis
The main aim of the project is to evaluate the concept of dose-binding chemotherapy drugs as a means of improving pharmacy efficiency and reducing patients waiting times. This study aims to compare the plasma profiles of the drug 5FU in breast cancer patients receiving dose-banded and the usual, individually prepared, doses as part of their normal FEC chemotherapy regimen.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Cancer: Breast
Intervention
Randomised controlled trial
Intervention type
Drug
Phase
Not Applicable
Drug names
5FU
Primary outcome measures
The comparative plasma concentration profiles (Cmax, AUC) in patients receiving dose-banded and individually prepared doses of 5 Fluorouracil.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/03/2002
Overall trial end date
01/03/2007
Reason abandoned
Eligibility
Participant inclusion criteria
Women with breast cancer who are receiving adjuvant therapy.
Participant type
Patient
Age group
Not Specified
Gender
Female
Target number of participants
26
Participant exclusion criteria
Patients on reduced doses of FEC chemotherapy, with known liver metastases, who have received chemotherapy for previous malignancies.
Recruitment start date
01/03/2002
Recruitment end date
01/03/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St James's University Hospital
Leeds
LS9 7TF
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Leeds Teaching Hospitals NHS Trust (UK), NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary