PhaRmacogEnomiC medIcines optimiSatIon for peOple with caNcer – a multicentre teletrial enabled Interrupted Time Series trial (PRECISION-ITS): Pharmacogenomics primary study and discovery program

Not Applicable

• Conditions: Cancer and other malignant neoplasms; Cancer - Any cancer; Public Health - Health service research

• Registration Number: ACTRN12624000079549
• Lead Sponsor: Peter MacCallum Cancer Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-01-30
• Last Update Posted: 5 February 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 1470

Inclusion Criteria

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 Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified