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.

Peter MacCallum Cancer Centre0 个研究点目标入组 200 人开始时间: 2024年1月30日最近更新: 2024年2月5日

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•Inclusion Criteria:
•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 Criteria:
•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

发起方

Peter MacCallum Cancer Centre