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 |
| Protocol serial number | N0436118084 |
| Sponsor | Department of Health |
| Funder | Leeds Teaching Hospitals NHS Trust (UK), NHS R&D Support Funding |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 5FU |
| Primary outcome measure(s) |
The comparative plasma concentration profiles (Cmax, AUC) in patients receiving dose-banded and individually prepared doses of 5 Fluorouracil. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/03/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
St James's University Hospital
Leeds
LS9 7TF
United Kingdom
LS9 7TF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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
