Condition category
Cancer
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
12/12/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

All study participants will be 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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes