| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN46112469 |
| Date ISRCTN assigned | 30/09/2005 |
| Local reference number(s) | N0436118084 |
| Public title | A comparative pharmacokinetic study: 5 Fluorouracil (5FU) provided as patient specific individual doses and as standard doses according to a "dose banding" principle |
| Scientific title |
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| Acronym | N/A |
| Disease/condition/study domain | Cancer: Breast |
| 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom
|
| Participants - inclusion criteria | All study participants will be women with breast cancer who are receiving adjuvant therapy. |
| Participants - exclusion criteria | Patients on reduced doses of FEC chemotherapy, with known liver metastases, who have received chemotherapy for previous malignancies. |
| Patient information material |
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| Anticipated start date | 01/03/2002 |
| Anticipated end date | 01/03/2007 |
| Status of trial | Completed |
| Target number of participants | 26 |
| Interventions | Randomised controlled trial |
| Primary outcome measure(s) | The comparative plasma concentration profiles (Cmax, AUC) in patients receiving dose-banded and individually prepared doses of 5 Fluorouracil. |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Leeds Teaching Hospitals NHS Trust
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK) |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Ms V A Walker |
| Contact details | Department of Medical Oncology
Level 4
Gledhow Wing
St James's University Hospital
Leeds
United Kingdom
LS9 7TF |
| Contact telephone | +44 (0)113 243 3144 |
| Contact fax | +44 (0)113 242 6496 |
| Contact email | r&d@leedsth.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN46112469 |
| Date last extracted from ISRCTN register | 17/04/2008 |
