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A comparative pharmacokinetic study: 5 Fluorouracil (5FU) provided as patient specific individual doses and as standard doses according to a 'dose banding' principle

A comparative pharmacokinetic study: 5 Fluorouracil (5FU) provided as patient specific individual doses and as standard doses according to a 'dose banding' principle

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN46112469
Enrollment
26
Registered
2005-09-30
Start date
2002-03-01
Completion date
Unknown
Last updated
2017-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer: Breast Cancer Breast cancer

Interventions

Randomised controlled trial

Sponsors

Department of Health
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Women with breast cancer who are receiving adjuvant therapy.

Exclusion criteria

Exclusion criteria: Patients on reduced doses of FEC chemotherapy, with known liver metastases, who have received chemotherapy for previous malignancies.

Design outcomes

Primary

MeasureTime frame
The comparative plasma concentration profiles (Cmax, AUC) in patients receiving dose-banded and individually prepared doses of 5 Fluorouracil.

Secondary

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026