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RecruitingLast updated: 30 January 2026

PRECISION-ITS: This study will assess the feasibility, acceptability and impact of pre-emptive testing and prescribing in people with cancer who are starting chemotherapyPhaRmacogEnomiC medIcines optimiSatIon for peOple with caNcer – a multicentre teletrial enabled Interrupted Time Series trial (PRECISION-ITS): Medication safety outcomes in the Pharmacogenomics primary study and discovery program

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Trial acronym

PRECISION-ITS

Clinical summary

Summary

Eligible participants will be allocated to either the intervention group or the control group depending on when they enter the study.

All participants will undergo standard and discovery pharmacogenomic panel testing. Standard panel test results and dosing recommendations (based on panel results) will be provided to all participants and their clinician before commencement of anti-cancer treatment.

Participants in the control group will receive dosing recommendations for Fluorouracil and Irinotecan chemotherapy. 

Participants in the intervention group will receive dosing recommendations for Fluorouracil, Irinotecan and other commonly used medicines in the treatment or supportive care of cancer.

Participants will be followed up 5 times over a 12-week period. The first visit will occur within 30 days of commencement of anti-cancer treatment. Subsequent visits will occur 1 week, 4 weeks, 8 weeks and 12 weeks after anti-cancer treatment commencement. At each follow up visist, participants will complete questionnaires regarding symptom burden/toxicity and quality of life.

This is the primary PRECISION-ITS trial. There is a nested cohort substudy with the registration number ACTRN12624000078550.

Conditions

This trial is treating people with gastrointestinal cancer, breast cancer, head and neck cancer, Hodgkin's lymphoma or non-Hodgkin's lymphoma

Eligibility

Inclusion

 

Inclusion Criteria for Patients not receiving 5-FU therapeutic drug monitoring (TDM):
1. Aged 18 years or older
2. Meets at least one criterion related to cancer diagnosis and treamtent:
2.1 UGI/LGI cancer commencing first-line systemic anticancer therapy with first exposure to 5-FU or , capecitabine, or systemic anticancer treatment with first exposure to irinotecan (utilised first or subsequent line) for any stage disease with curative or palliative intent (concurrent radiotherapy and other anticancer therapies permitted).
2.2 Breast cancer commencing any CDK4/6 inhibitor, capecitabine, or Sacituzumab govitecan in any line of therapy for any stage disease, with curative or palliative intent (concurrent hormone therapies and other anticancer therapies permitted).
2.3 Head and neck cancer commencing curative intent chemo-radiotherapy with high dose cisplatin (70mg/m2 or higher planned dose), with or without immunotherapy.
2.4 HL commencing treatment with ABVD-like or escalated BEACOPP-like pathways.
2.5 NHL commencing treatment with HyperCVAD, CODOX-M, or treatment containing high-dose methotrexate
2.6 CUP receiving treatment for presumed diagnosis of an included cancer and meeting treatment requirements specified for included cancers (2.1 to 2.5)
3. Diagnostic workup and treatment plan 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

Patients with metastatic/unresectable colorectal cancer receiving 5-FU TDM will also be included in the primary PGx study.

Inclusion Criteria for patients participating in 5-FU TDM:
1. Aged 18 years or older
2. Metastatic or unresectable colorectal cancer commencing first-line 5-FU based systemic anticancertherapy 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 writteninformed consent.
5. Patient and/or carer can complete patient surveys
6. Study enrolment limit has not been reached

Exclusion

 

Exclusion Criteria for Patients not receiving 5-FU TDM:
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 PGx drug of interest (Appendix 1) as an investigational medicinal product in another interventional clinical drug trial that prohibits concurrent enrolment (as part of eligibility criteria or at 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. Patients receiving HIPEC (due to differences in treatment pathways and routine follow-up schedules).
6. Does not meet inclusion criteria

The same exclusion criteria apply for patients receiving 5-FU TDM.

Exclusion Criteria for patients receiving 5-FU TDM:
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 diff erences in treatment pathways and routine follow-upschedules).
5. Patient is receiving HIPEC (due to differences in treatment pathways and routine follow-up schedules).
6. Does not meet inclusion criteria

Inclusion

  • You are currently receiving treatment for your cancer.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You are currently being treated on a clinical trial.
  • You have had certain treatments, surgical procedures or drugs.
Message

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.

Participating hospitals

This trial is operating as a teletrial at one or more locations. Learn more about teletrials.

Recruiting hospitals

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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): Medication safety outcomes in the Pharmacogenomics primary study and discovery program

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