A comparative pharmacokinetic study: 5 Fluorouracil (5FU) provided as patient specific individual doses and as standard doses according to a 'dose banding' principle
| ISRCTN | ISRCTN46112469 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46112469 |
| Secondary identifying numbers | N0436118084 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 14/06/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms V A Walker
Scientific
Scientific
Department of Medical Oncology
Level 4
Gledhow Wing
St James's University Hospital
Leeds
LS9 7TF
United Kingdom
| Phone | +44 (0)113 243 3144 |
|---|---|
| r&d@leedsth.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cancer: Breast |
| Intervention | Randomised controlled trial |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 5FU |
| Primary outcome measure | 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 study start date | 01/03/2002 |
| Completion date | 01/03/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target number of participants | 26 |
| Key inclusion criteria | Women with breast cancer who are receiving adjuvant therapy. |
| Key exclusion criteria | Patients on reduced doses of FEC chemotherapy, with known liver metastases, who have received chemotherapy for previous malignancies. |
| Date of first enrolment | 01/03/2002 |
| Date of final enrolment | 01/03/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
St James's University Hospital
Leeds
LS9 7TF
United Kingdom
LS9 7TF
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Hospital/treatment centre
Leeds Teaching Hospitals NHS Trust (UK), NHS R&D Support Funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
14/06/2017: No publications found in PubMed, verifying study status with principal investigator
