PREDICT Fluorouracil (5-FU): A Study to Describe the Feasibility of Therapeutic Drug Monitoring of 5-FU in Cancer Treatment

Not Applicable

• Conditions: Gastrointestinal cancer; Breast Cancer; Head and Neck Cancer; Cancer - Bowel - Back passage (rectum) or large bowel (colon); Cancer - Breast; Cancer - Head and neck

• Registration Number: ACTRN12620001147976
• Lead Sponsor: niversity of Newcastle

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-02
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Any patient scheduled for infusional 5-FU greater than 24 hours, or capecitabine treatment, along or in combination.

Available and willing to have blood tests inthe period after initiation of treatment

Can provide signed, written informed consent.

Exclusion Criteria

None

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The feasibility of pK testing will be determined by the amount of samples analysed for 5-FU. [Patients will be assessed at day 1, cycle 1 post registration chemotherapy.];Determination of AUC.[Blood sample during treatment - 18 hours after the start of 5fu infusion.]

Secondary Outcome Measures

Name	Time	Method
Toxicities will be assessed using the CTCAE v5.0. [Day 1, cycle 2.];Turn around time for 5-FU results[within one week of blood test]