Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001147976
Ethics application status
Approved
Date submitted
1/09/2020
Date registered
2/11/2020
Date last updated
2/11/2020
Date data sharing statement initially provided
2/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
PREDICT Fluorouracil (5-FU): A Study to Describe the Feasibility of Therapeutic Drug Monitoring of 5-FU in Cancer Treatment
Scientific title
PREDICT 5-FU: A Study to Describe the Feasibility of Therapeutic Drug Monitoring of 5-FU in Cancer Treatment
Secondary ID [1] 302124 0
NIL
Universal Trial Number (UTN)
U1111-1257-3856
Trial acronym
PREDICT 5-FU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal cancer 318791 0
Breast Cancer 319229 0
Head and Neck Cancer 319230 0
Condition category
Condition code
Cancer 316805 316805 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 316806 316806 0 0
Breast
Cancer 316807 316807 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients prescribed 5-FU/Capecitabine as part of their standard of care treatment will provide an additional 2 blood samples and a single dried blood spot for therapeutic drug monitoring.

Samples will be collected by either doctor, research nurse or pathology collector. The first sample is collected at the patient's screening visit with other routine blood samples. The second sample will be collected additionally during the patient's treatment and will require 10 minutes for collection.

Levels of drug will be provided back to clinician and dose of 5-FU/Capecitabine may change based on individual clinicians clinical judgement.

The level of drug in blood sample will be correlated with level of drug in dried blood spot for feasibility of using dried blood spot and/or whole blood samples for ongoing therapeutic drug monitoring of 5-FU/Capecitabine.

The change (is applicable) and outcome will be collected.
Intervention code [1] 318708 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324919 0
The feasibility of pK testing will be determined by the amount of samples analysed for 5-FU.
Timepoint [1] 324919 0
Patients will be assessed at day 1, cycle 1 post registration chemotherapy.
Primary outcome [2] 325270 0
Determination of AUC.
Timepoint [2] 325270 0
Blood sample during treatment - 18 hours after the start of 5fu infusion.
Secondary outcome [1] 386208 0
Toxicities will be assessed using the CTCAE v5.0.
Timepoint [1] 386208 0
Day 1, cycle 2.
Secondary outcome [2] 387369 0
Turn around time for 5-FU results
Timepoint [2] 387369 0
within one week of blood test

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Study to determine the feasibility of a TDM Service by determining turn-around time between sampling and receiving dosing advice.
Phase
Not Applicable
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis
This is a non-interventional non-comparative clinical study. Demographic and clinical data will require simple statistical comparison of the 5-FU pk parameters (AUC) and toxicity. Univariate and multivariate analysis using logistic regression to identify potential predictive factors for toxicity (age, gender, ECOG PS, creatinine, other standard blood parameters, 5-FU dose, and 5-FU pk, uracil and DPD parameters) will be undertaken

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/11/2020
Actual
Date of last participant enrolment
Anticipated
30/11/2021
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 17329 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 17330 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 17331 0
Lake Macquarie Private Hospital - Gateshead
Recruitment hospital [4] 17332 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [5] 17333 0
Dubbo Base Hospital - Dubbo
Recruitment hospital [6] 17334 0
Wollongong Hospital - Wollongong
Recruitment hospital [7] 17335 0
Wyong Public Hospital - Hamlyn Terrace
Recruitment hospital [8] 17336 0
Gosford Hospital - Gosford
Recruitment postcode(s) [1] 31057 0
3000 - Melbourne
Recruitment postcode(s) [2] 31058 0
2170 - Liverpool
Recruitment postcode(s) [3] 31059 0
2290 - Gateshead
Recruitment postcode(s) [4] 31060 0
2200 - Bankstown
Recruitment postcode(s) [5] 31061 0
2830 - Dubbo
Recruitment postcode(s) [6] 31062 0
2500 - Wollongong
Recruitment postcode(s) [7] 31063 0
2259 - Hamlyn Terrace
Recruitment postcode(s) [8] 31064 0
2250 - Gosford

Funding & Sponsors
Funding source category [1] 306550 0
Charities/Societies/Foundations
Name [1] 306550 0
Cancer Council NSW
Country [1] 306550 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 307152 0
None
Name [1] 307152 0
Address [1] 307152 0
Country [1] 307152 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306740 0
Peter MacCallum Cancer Centre
Ethics committee address [1] 306740 0
305 Grattan Street
Melbourne VIC 3000
Ethics committee country [1] 306740 0
Australia
Date submitted for ethics approval [1] 306740 0
26/11/2019
Approval date [1] 306740 0
18/03/2020
Ethics approval number [1] 306740 0
HREC/58470/PMCC-2019

Summary
Brief summary
The purpose of this study is to investigate whether it is possible for blood samples to be used to monitor whether the correct dose of cancer medicines are being provided to patients.

Who is it for?
You may be eligible for this study if you are an adult who is receiving Fluorouracil (5-FU) or Capecitabine for the treatment of cancer.

Study details
All participants in this study will need to provide two blood samples and one dried blood spot sample at two visits with a pathologist. Any results from these samples will then be provided to your oncologist.

It is hoped that this research will help determine if it is possible to monitor the dose of medication needed per individual using blood samples.
Trial website
https://www.newcastle.edu.au/research/centre/clinical-pharmacology/research/predict
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104858 0
Prof Jennifer Martin
Address 104858 0
The University of Newcastle
University Drive
Callaghan NSW 2308
Country 104858 0
Australia
Phone 104858 0
+61240420851
Fax 104858 0
Email 104858 0
[email protected]
Contact person for public queries
Name 104859 0
Prof Jennifer Martin
Address 104859 0
The University of Newcastle
University Drive
Callaghan NSW 2308
Country 104859 0
Australia
Phone 104859 0
+61 2 404 20908
Fax 104859 0
Email 104859 0
[email protected]
Contact person for scientific queries
Name 104860 0
Prof Jennifer Martin
Address 104860 0
The University of Newcastle
University Drive
Callaghan NSW 2308
Country 104860 0
Australia
Phone 104860 0
+61240420851
Fax 104860 0
Email 104860 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.