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Trial registered on ANZCTR
Registration number
ACTRN12624000078550
Ethics application status
Approved
Date submitted
21/11/2023
Date registered
30/01/2024
Date last updated
30/01/2024
Date data sharing statement initially provided
30/01/2024
Type of registration
Prospectively registered
Titles & IDs
Public 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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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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Secondary ID [1]
310978
0
MRFMMIP000011
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Universal Trial Number (UTN)
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Trial acronym
PRECISION-ITS
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Linked study record
Linked to the primary trial:
1. PhaRmacogEnomiC medIcines optimiSatIon for peOple with caNcer – a multicentre teletrial enabledInterrupted Time Series trial (PRECISION-ITS): Medication safety outcomes in the Pharmacogenomics primary study and discovery program
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Health condition
Health condition(s) or problem(s) studied:
Metastatic or unresectable colorectal cancer
332063
0
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Condition category
Condition code
Cancer
328791
328791
0
0
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Bowel - Back passage (rectum) or large bowel (colon)
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Public Health
329059
329059
0
0
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Health service research
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The intervention is combined TDM and PGx-guided 5-FU prescribing.
5-FU TDM results, including recommended dose adjustments based on exposure levels (AUC), will be provided to the treating clinician based on the International Association of Therapeutic Drug Monitoring and Clinical Toxicology Recommendations for 5-Fluorouracil Therapy. It is the decision of the clinician to implement/not implement dose changes after considering both exposure levels and other clinical factors such as observed toxicities and treatment intent/patient goals of care. TDM will commence from the patient’s first chemotherapy cycle and will be repeated at consecutive chemotherapy cycles of 5-FU until the target AUC is reached (20-30mg – h/L). Dosing recommendations will be based on single timepoint blood sample collection 18-40hours after commencement of infusional 5-FU. At trial commencement this will be based on peripheral blood sample results, with the aim for within trial validation and conversion to finger prick blood sampling. The first set of samples (consisting of 2 finger prick blood samples) will be self-collected by participants 3-17 hours after commencement of infusional 5-FU. The second set of samples (consisting of 1 peripheral + 2 finger prick blood samples) will be collected by qualified site staff 18-40 hours after commencement of infusional 5-FU to ensure viable samples are consistently collected and to allow for feasibility assessments of patient self-testing. Patients will receive a TDM self-testing kit (designed specifically for this substudy) and education from the pharmacogenomics pharmacist on how to use the kit. Finger prick blood samples will be collected with a Volumetric Absorptive Microsampling (VAMS) device and dried plasma separation card.
Participants recruited in this substudy will also participate in the PRECISION-ITS primary PGx trial and undergo PGx testing/prescribing/clinical follow up (as per the primary PGx trial), but will have additional trial visits due to TDM. Participants enrolled in Time Series 1 and 2 in the primary PGx trial will be able to participate in this substudy if they are receiving infusional 5-FU for metastatic/unresectable colorectal cancer. In the primary PGx trial, Time Series 2 will commence 3-4 months after accrual to Time Series 1 is completed.
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Intervention code [1]
327409
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Early detection / Screening
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Intervention code [2]
327410
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Treatment: Other
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Intervention code [3]
327411
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Behaviour
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Comparator / control treatment
There will be 2 historic comparator/control treatments, which reflect standard care practices for 5-FU prescribing:
1. Control 1 = BSA/PGx-guided prescribing for 5-FU without TDM. Patients within this control group would have received this intervention for various 5-FU-based chemotherapy regimens with or without radiotherapy between 7 Jan 2021 and 25 Feb 2022 in the PACIFIC-PGx trial (ACTRN12621000251820), or for fluoropyrimidine-based anticancer therapy with or without radiotherapy/other chemotherapeutic agents between 30 April 2015 and 21 Dec 2017 in the trial conducted by Henricks et al (NCT02324452).
2. Control 2 = BSA-guided prescribing for 5-FU without TDM and without PGx for various 5-FU-based chemotherapy regimens with or without radiotherapy/other chemotherapeutic agents, from previously published, prospective clinical trials with no limitation relating to year of treatment. Trials included will be dependent on availability of required datapoints.
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Control group
Historical
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Outcomes
Primary outcome [1]
336599
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Overall Response Rates (ORR) to cancer treatment in patients with metastatic/unresectable colorectal cancer receiving infusional 5-FU.
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Assessment method [1]
336599
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Real world ORR defined as the percentage of patients with best response of complete or partial response (CR/PR) among patients with available standard of care response assessments within 12 weeks after commencement of anticancer therapy, as reported by treating clinicians based on RECIST 1.1 definitions in the medical record.
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Timepoint [1]
336599
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12 weeks after commencement of systemic anticancer treatment.
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Secondary outcome [1]
428925
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5-FU therapeutic drug levels within target range (AUC equal to 20-30mg - h/L).
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Assessment method [1]
428925
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Proportion of patients with 5-FU TDM who achieve 5-FU drug concentration in the target range (AUC equal to 20-30mg - h/L) at the final TDM assessment compared to cycle 1 (no TDM). Patients will have TDM performed at consecutive cycles until the target therapeutic range is reached (Target AUC equal to 20-30 mg – h/L).
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Timepoint [1]
428925
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First 5-FU chemotherapy cycle (nil TDM), and last cycle of 5-FU utilising TDM.
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Secondary outcome [2]
428928
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Adverse events (clinician reported)
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Assessment method [2]
428928
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1. Incidence of adverse medicines events reported by clinicians.
Clinician reported adverse medicines events among patients receiving PGx/TDM 5-FU prescribing will be compared to patient controls receiving standard of care (control) prescribing. The Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 will be used to assess adverse medicines events.
Adverse medicines event is defined as either medicines-related toxicity which are grade 2 or higher non-haematological toxicity, and/or grade 3 or higher haematological toxicity occurring within 12 weeks of commencing anticancer therapy. Non-haematologic events are included at grade 2 or above given there are harmful and debilitating adverse medicines events at this threshold (i.e. diarrhoea +6 stools/day, vomiting requiring intravenous hydration, pain limiting instrumental activities of daily living).
Clinician-reported adverse medicines events will be assessed over the 12-week primary follow up period.
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Timepoint [2]
428928
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12 weeks after commencement of systemic anticancer treatment
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Secondary outcome [3]
428932
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Adverse medicines events (patient reported)
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Assessment method [3]
428932
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1. Incidence of AME reported by patients.
Patient-reported adverse medicines events among patients receiving PGx/TDM 5-FU prescribing will be compared to patient controls receiving standard of care (control) prescribing.
Adverse medicines events will be assessed by 2 patient surveys: the Patient Reported Outcomes Common Terminology Criteria (PRO-CTCAE) survey & Brief Pain Inventory (BPI) survey. The PRO-CTCAE was developed by the National Institutes of Health to evaluate symptomatic toxicities experienced by patients in cancer trials. It was designed as a companion to the CTCAE (which is the standard lexicon for adverse event reporting by clinicians in cancer trials and chosen tool for assessment of secondary outcome for adverse events). The PRO-CTCAE and CTCAE were developed and validated according to international standards. The BPI is a validated tool for patient-reported cancer pain. Both of these surveys are widely used in research and clinical settings. Surveys will be distributed online and/or via hard copy to participants over the 12-week primary follow up period.
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Timepoint [3]
428932
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12 weeks after commencement of systemic anticancer treatment
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Secondary outcome [4]
428933
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Feasibility of patients to administer at-home TDM self-testing (finger prick blood samples)
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Assessment method [4]
428933
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Proportion of viable TDM samples (samples with measurable drug, among all samples) performed by trained laboratory staff compared to patients self-testing at home. Records of viable and unviable samples to be provided by TDM testing laboratory.
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Timepoint [4]
428933
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Last cycle of 5-FU utilising TDM among consecutively recruited patients undergoing both peripheral blood sampling and at home finger-prick sampling.
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Secondary outcome [5]
428934
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Feasibility of TDM testing
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Assessment method [5]
428934
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1. Timeliness of TDM testing: time from sample collection to reporting of results within the patient medical record.
2. Availability of TDM results: proportion of patients who undergo testing who have results available prior to commencing their next cycle of 5-FU treatment.
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Timepoint [5]
428934
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12 weeks after commencement of systemic anticancer treatment
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Secondary outcome [6]
428937
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Acceptability of TDM testing
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Assessment method [6]
428937
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1. Acceptability of TDM testing: responses to participant 5-FU TDM program acceptability surveys designed specifically for this study (which will be distributed 12 weeks after commencement of systemic anticancer therapy).
2. Reasons for not consenting: description of reasons patients’ declined TDM testing as reported in in short structured interview at time of consent declination. Descriptive reasons to be documented in medical record.
3. Uptake of TDM testing: number of patients who signed the 5-FU TDM PICF and provided a blood sample for TDM testing, among patients offered a PICF who qualified for 5-FU TDM. Will be assessed from the trial screening log.
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Timepoint [6]
428937
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12 weeks after commencement of systemic anticancer therapy
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Secondary outcome [7]
428938
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Feasibility of 5-FU TDM-optimised prescribing
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Assessment method [7]
428938
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1. Timeliness of TDM dose recommendations: time from sample collection to reporting of TDM results/dose recommendations within the patient medical record.
2. Availability of TDM dose recommendations:: proportion of patients who undergo testing who have results/dose recommendations prior to commencing their next cycle of 5-FU treatment.
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Timepoint [7]
428938
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12 weeks after commencement of systemic anticancer treatment
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Secondary outcome [8]
428941
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Acceptability of TDM dose recommendations (including uptake/timeliness)
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Assessment method [8]
428941
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1. Acceptability of TDM dosing: responses to health professional 5-FU TDM program acceptability surveys designed specifically for this study (which will be distributed 12 weeks after commencement of systemic anticancer therapy).
2.. Prescriber uptake of TDM dose recommendations: proportion of patients with TDM-guided dosing implemented, among patients with results/recommendations reported which include recommendation for modification. Will be assessed from medical record and trial database.
3. Reasons why prescribers do not implement TDM dosing recommendations: descriptive reasons to be documented in medical record and entered into trial database.
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Timepoint [8]
428941
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12 weeks after commencement of systemic anticancer therapy .
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Secondary outcome [9]
428942
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Acceptability of pharmacist education for 'at home' 5-FU TDM testing (finger prick blood samples).
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Assessment method [9]
428942
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Acceptability of the pharmacist education for 5-FU at-home TDM testing (finger prick blood samples), as assessed by participant interview and responses to participant 5-FU TDM program acceptability surveys designed specifically for this study (which will be distributed 12 weeks after commencement of systemic anticancer therapy)
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Timepoint [9]
428942
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12 weeks after commencement of systemic anticancer therapy.
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Secondary outcome [10]
428943
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Validation of 5-FU dosing algorithms for finger prick blood samples.
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Assessment method [10]
428943
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Relationship between volumetric absorptive microsampling (VAMS), dried plasma spot samples and plasma 5-FU concentrations will be reported by finger prick validation assay reports from TDM testing laboratories.
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Timepoint [10]
428943
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Last cycle of 5-FU utilising TDM for the ~50th consecutively recruited patient.
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Secondary outcome [11]
429970
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ORR at 12 months
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Assessment method [11]
429970
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ORR defined as percentage of patients with ongoing CR/PR at 12 months among all patients with standard of care response assessments as reported by treating clinicians in the medical record based on RECIST 1.1 definitions.
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Timepoint [11]
429970
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12 months after commencement of systemic anticancer therapy
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Secondary outcome [12]
429972
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Overall survival (OS) rate at 12 months.
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Assessment method [12]
429972
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OS rate defined as the percentage of patients alive at 12 months after commencement of cancer treatment, among all patients enrolled, by time series.
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Timepoint [12]
429972
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12 months after commencement of systemic anticancer therapy
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Secondary outcome [13]
429973
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OS at 12 months
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Assessment method [13]
429973
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OS is defined as median (95% CI) time commencement of cancer treatment to death by any cause among all patients enrolled by time series, with living patients censored at last follow-up.
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Timepoint [13]
429973
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12 months after commencement of systemic anticancer therapy
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Secondary outcome [14]
429974
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Progression free survival (PFS) at 12 months
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Assessment method [14]
429974
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PFS is defined as median (95% CI) time from commencement of cancer treatment to first occurring event of disease progression or death by any cause among all patients enrolled by time series, with living patients censored at last follow-up. Progressive disease will be reported by treating clinicians in the medical record based on RECIST 1.1 definitions .
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Timepoint [14]
429974
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12 months after commencement of systemic anticancer therapy
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Secondary outcome [15]
430142
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Disease Control Rate (DCR) at 12 months
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Assessment method [15]
430142
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Real world DCR defined as percentage of patients with ongoing CR/PR/ stable disease (SD) at 12 months, among patients with available standard of care response assessments within 12 months after commencement of anticancer therapy, as reported by treating clinicians in the medical record based on RECIST 1.1 definitions.
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Timepoint [15]
430142
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12 months after commencement of systemic anticancer therapy
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Secondary outcome [16]
430143
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Duration Overall Response (DOR) at 12 months
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Assessment method [16]
430143
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DOR defined as median response time among all patients with ongoing CR/PR standard of care response assessments at 12 months, as reported by treating clinicians in the medical record based on RECIST 1.1 definitions.
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Timepoint [16]
430143
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12 months after commencement of systemic anticancer therapy
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Secondary outcome [17]
430144
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Duration Disease Control (DDC) at 12 months
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Assessment method [17]
430144
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DDC defined as median response time among those with disease control (CR/PR/SD) at 12 months as reported by treating clinicians in the medical record based on RECIST 1.1 definitions.
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Timepoint [17]
430144
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12 months after commencement of systemic anticancer therapy
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Eligibility
Key inclusion criteria
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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
Interrupted time series trial where participants in Time Series 1 and 2 of the 5-FU TDM substudy will receive study intervention of combined TDM/PGx 5-FU prescribing, and be compared to historical cohorts from previous trials with standard care 5-FU prescribing practices.
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
The 5-FU TDM nested cohort study is powered to demonstrate a difference in overall response rate (ORR) (primary endpoint) and 5-FU drug concentration within target therapeutic range (secondary endpoint),among individuals treated with infusional 5-FU with or without radiotherapy and other systemic agents for unresectable or metastatic colorectal cancer with TDM-augmented pharmacogenomics prescribing (PRECISION-ITS Time Series 1 & 2) versus 1) pharmacogenomics and body surface area prescribing(historic cohort 1) and 2) body surface area prescribing without pharmacogenomics or TDM (historic cohort 2).
The Pharmacogenomics + TDM prescribing arm (intervention) will come from the PRECISION ITS trial (both time series). The Pharmacogenomics + BSA prescribing arm (control 1) will come from pooled historic cohorts (prospective studies). The BSA prescribing arm (control 2) will come from pooled historic cohorts (prospective studies dependent on availability of required data-points and representation of final included regimens).
A sample size of 400 patients (200 PGx and 200 PGx + TDM) will provide 80% power to detect a minimum 15% absolute increase in the primary endpoint of ORR (two-sided a equal to 5%, 50%, 65%), allowing for 10% drop-out. Calculation is based on 50% ORR without TDM as the lowest likely ORR in our real-world unresectable or metastatic colorectal cancer cohort, based on published literature requiring the largest sample size. Allowing this sample size will provide sufficient power (80%) for an ORR between 50-70%. The target 15% absolute increase in ORR was selected as a clinically meaningly difference and is based on minimum observed improvements from previous 5-FU TDM studies.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
5/02/2024
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Actual
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Date of last participant enrolment
Anticipated
29/03/2026
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Actual
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Date of last data collection
Anticipated
31/08/2027
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
25854
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [2]
25855
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Bendigo Health Care Group - Bendigo Hospital - Bendigo
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Recruitment hospital [3]
25856
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Border Medical Oncology - Albury
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Recruitment hospital [4]
25857
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Goulburn Valley Health - Shepparton campus - Shepparton
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Recruitment hospital [5]
25858
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Barwon Health - Geelong Hospital campus - Geelong
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Recruitment hospital [6]
25859
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South West Healthcare - Warrnambool - Warrnambool
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Recruitment hospital [7]
25860
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Mildura Base Hospital - Mildura
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Recruitment hospital [8]
25861
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Latrobe Regional Hospital - Traralgon
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Recruitment postcode(s) [1]
41681
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3000 - Melbourne
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Recruitment postcode(s) [2]
41682
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3550 - Bendigo
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Recruitment postcode(s) [3]
41683
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2640 - Albury
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Recruitment postcode(s) [4]
41684
0
3630 - Shepparton
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Recruitment postcode(s) [5]
41685
0
3220 - Geelong
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Recruitment postcode(s) [6]
41686
0
3280 - Warrnambool
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Recruitment postcode(s) [7]
41687
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3500 - Mildura
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Recruitment postcode(s) [8]
41688
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3844 - Traralgon
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Funding & Sponsors
Funding source category [1]
315237
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Hospital
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Name [1]
315237
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Peter MacCallum Cancer Centre
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Address [1]
315237
0
305 Grattan St Melbourne VIC 3000
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Country [1]
315237
0
Australia
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Funding source category [2]
315241
0
Government body
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Name [2]
315241
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Department of Health and Aged care (Medical research future fund)
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Address [2]
315241
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Department of Health and Aged Care - GPO Box 9848 Canberra ACT 2601
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Country [2]
315241
0
Australia
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Primary sponsor type
Hospital
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Name
Peter MacCallum Cancer Centre
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Address
305 Grattan St Melbourne VIC 3000
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Country
Australia
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Secondary sponsor category [1]
317269
0
None
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Name [1]
317269
0
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Address [1]
317269
0
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Country [1]
317269
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
314161
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Peter MacCallum Cancer Centre Human Research Ethics Committee
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Ethics committee address [1]
314161
0
305 Grattan St
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Ethics committee country [1]
314161
0
Australia
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Date submitted for ethics approval [1]
314161
0
12/09/2023
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Approval date [1]
314161
0
30/10/2023
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Ethics approval number [1]
314161
0
HREC/101174/PMCC (23/149)
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Summary
Brief summary
This multi-centre, prospective, tele-trial aims to evaluate the safety and efficacy of 5-Fluorouracil (5-FU) Therapeutic Drug Monitoring (TDM) in patients with metastatic/unresectable colorectal cancer. This trial will also assess the feasibility and acceptability of participants to conduct 'at-home' TDM self-testing. Who is it for? You may be eligible to join this study if you are aged 18 years and older, and 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/unresectable colorectal cancer. Study details This is a sub-study of the PRECISION-ITS trial, all participants in this substudy will also participate in the primary PRECISION-ITS trial. In this substudy, patients will receive combined pharmacogenomics and 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 commencement of 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. It is hoped that this trial will show that a combined pharmacogenomics/TDM prescribing approach for 5-FU increases treatment response to 5-FU based chemotherapy in metastatic/unresectable colorectal cancer, and that 'at-home', finger prick TDM testing by patients is feasible (thereby reducing patient burden for venous blood tests).
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Marliese Alexander
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Address
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Peter MacCallum Cancer Centre - Pharmacy Department, 305 Grattan St, Melbourne VIC 3000
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Country
130634
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Australia
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Phone
130634
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+61385596137
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Fax
130634
0
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Email
130634
0
[email protected]
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Contact person for public queries
Name
130635
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Vivian Shen
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Address
130635
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Peter MacCallum Cancer Centre - Pharmacy Department, 305 Grattan St, Melbourne VIC 3000
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Country
130635
0
Australia
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Phone
130635
0
+61385595628
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Fax
130635
0
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Email
130635
0
[email protected]
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Contact person for scientific queries
Name
130636
0
Vivian Shen
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Address
130636
0
Peter MacCallum Cancer Centre - Pharmacy Department, 305 Grattan St, Melbourne VIC 3000
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Country
130636
0
Australia
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Phone
130636
0
+61385595628
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Fax
130636
0
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Email
130636
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Shared data will be limited to the data within the trial dataset approved by the PRECISION-ITS steering committee and sponsor.
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When will data be available (start and end dates)?
Data will be available 2 years after publication of primary results.
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Available to whom?
Researchers whose proposed use of the data has been approved.
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Available for what types of analyses?
Meta analyses
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How or where can data be obtained?
By request to the CPI (
[email protected]
) or co-principal investigator (
[email protected]
) and signed data access agreement.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
20936
Study protocol
[email protected]
Study protocol will be provided to approved applic...
[
More Details
]
20937
Informed consent form
[email protected]
Informed consent forms will be provided to approve...
[
More Details
]
20938
Ethical approval
[email protected]
Ethical approval certifi cate will be provided to ...
[
More Details
]
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.
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