Trial purpose
Cancer treatment
Tumor type
Lower gastrointestinal tract
Age
18+
Trial acronym
PRECISION-ITS
Clinical summary
Summary
This is a nested cohort substudy of the primary PRECISION-ITS study (ACTRN12624000079549), all participants in this substudy will also participate in the primary PRECISION-ITS trial.
This substudy is recruiting people who are planning to commence infusional 5-FU-based chemotherapy that is used first-line or subsequent line (if being treated with Irinotecan for the first time) for metastatic or unresectable colorectal cancer.
All participants will receive combined pharmacogenomics and therapeutic drug monitoring (TDM) prescribing for 5-FU. Pharmacogenomic test results and dosing recommendations (based on panel results) will be provided to all participants and their clinician before beginning chemotherapy. TDM test results and dosing recommendations will be reported by the pharmacogenomics pharmacist to the participant's clinician(s) in real-time before the next chemotherapy cycle.
TDM will commence from the first cycle of chemotherapy and continue at consecutive chemotherapy cycles until target 5-FU drug levels are reached.
At each chemotherapy cycle requiring TDM, participants will be asked to provide blood samples 3-17 hours and 18-40 hours after commencement of infusional 5-FU. The first sample will be self-collected by participants via finger prick blood collection devices. The second sample (consisting of finger prick and venous blood samples) will be collected by site staff. Participants will receive education from the pharmacogenomics pharmacist on how to conduct TDM self-testing and sample delivery.
Conditions
This trial is treating people with metastatic or inoperable (unresectable) colorectal cancer who are about to start chemotherapy treatment for their advanced disease
Eligibility
Inclusion
1. Aged 18 years or older
2. Metastatic or unresectable colorectal cancer commencing first-line 5-FU based systemic anticancer therapy or 5-FU based systemic anticancer therapy with first exposure to irinotecan (utilised first or subsequent line); prior treatment for early stage disease permitted.
3. Diagnostic work-up and treatment planned to be undertaken at participating trial site.
4. Patient has capacity to provide consent using the ethics approved PICF, and has provided written informed consent.
5. Patient and/or carer can complete patient surveys
6. Study enrolment limit has not been reached
Exclusion
1. Commenced systemic anticancer therapy.
2. Referral to participating trial site for second opinion only, with no intent for treatment at the participating site.
3. Patients receiving a pharmacogenomics drug of interest (Appendix 1) as an investigational medicinal product in another interventional clinical drug trial that prohibits concurrent enrolment (as part of eligibility or PI’s discretion), or that represents an unreasonable burden of patient participation at the discretion of the patient or investigator.
4. Diagnosis of neuroendocrine cancer (due to differences in treatment pathways and routine follow-up schedules).
5. Patient is receiving HIPEC (due to differences in treatment pathways and routine follow-up schedules).
6. Does not meet inclusion criteria
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body (localised).
- Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:
Trial sponsor
Peter MacCallum Cancer Centre
Scientific Title
PhaRmacogEnomiC medIcines optimiSatIon for peOple with caNcer – a multicentre teletrial enabled Interrupted Time Series trial (PRECISION-ITS): A nested cohort substudy evaluating the safety & efficacy of 5-Fluorouracil Therapeutic Drug Monitoring in patients with metastatic/unresectable colorectal cancer.
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