Prospective pharmacokinetic study of continuous-infusional 5-FU

Prospective pharmacokinetic study of continuous-infusional 5-FU - Pharmacokinetic study of 5-FU

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000035580

Enrollment

Registered

2019-01-18

Start date

2019-01-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Gastrointestinal Cancers

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients who are planned for treatment with modified de Gramont regimen (5-FU 400mg/m2 bolus + 2400mg/m2 div + leucovorin) including mFOLFOX6, FOLFIRI, FOLFIRINOX, 5-FU/LV

Exclusion criteria

Exclusion criteria: 1)Uncontrolled diarrhea (Grade =>2)

Design outcomes

Primary

Measure	Time frame
Distribution of area under the time-concentration couve (AUC) of 5-FU	—

Secondary

Measure	Time frame
Correlation of AUC and 5-FU related adverse events. Impact of patient characteristics on AUC.	—

Countries

Japan

Contacts

Public ContactChiyo Imamura

Keio University, School of Medicine Department of clinical pharmacokinetics and pharmacodynamics

imamurack@z3.keio.jp03-5363-3706

Outcome results