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DEFINITIONS
Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12610000898055
Ethics application status
Approved
Date submitted
15/10/2010
Date registered
21/10/2010
Date last updated
2/07/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
The use of non invasive methods to predict drug handling and toxicity of Irinotecan
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Scientific title
The utility of genomics and functional imaging to predict Irinotecan pharmacokinetics and pharmacodynamics: The PREDICT Irinotecan Study
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Secondary ID [1]
252874
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PMCC Protocol No 10/55
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Universal Trial Number (UTN)
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Trial acronym
The PREDICT IR study
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Locally advanced, recurrent or metastatic colorectal adenocarcinoma
258404
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Condition category
Condition code
Cancer
258570
258570
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0
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Standard treatment of FOLFIRI or FOLFIRI-Avastin regimen for the period of 8 weeks
The Irinotecan will be given over 90 minutes followed by Leucovorin given intravenously over 2 hours and immediately followed by Avastin given over 1 hour if the doctor decides to combine it with FOLFIRI. 5FU will be given intravenously by rapid injection and then 5FU will be given over 46 hrs through a pump connected to the PORT/PICC. Patient will be educated about the care of the PICC or PORT and the pump. The pump will be disconnected at the end of the 46 hours performed at patient home.
Total duration of the study 4 years
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Intervention code [1]
257401
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Not applicable
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Comparator / control treatment
N/A
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Response assessment in the first 4 courses of treatment
using computed tomography (CT) scan and/or magnetic resonance imaging (MRI) and/or positron emission tomography (PET) and/or X-Ray and clinical examination.
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Assessment method [1]
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Timepoint [1]
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8 weeks
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Primary outcome [2]
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Correlations between functional imaging and PK
and between functional imaging and Toxicity
Associations will be assessed to examine the strength and direction of the linear relationship between HFI with PK and toxicity parameters. The Pearson correlation coefficient (for normally distributed variables) or nonparametric Spearman rank correlation (for any non-normally distributed variables) will be calculated with the correlation (r2) and p-value reported. Linear regression models to predict PK parameters from HFI parameters will be fitted to estimate the relationship between pairs of parameters identified as having a significant correlation coefficient. Logistic regression will be used to assess whether HFI parameters can predict presence or absence of grade delayed diarrhoea and neutropenia.
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Assessment method [2]
259418
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Timepoint [2]
259418
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In the 4th year of the project
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Primary outcome [3]
259419
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Correlations of genetic factors, with PK, toxicity and response
SNP genotypes will be assessed for deviations from Hardy-Weinberg equilibrium. Fisher's exact test or Pearson's chi-square test will be used, as appropriate, to assess the association between SNP genotypes with toxicity and objective response in 2 degree of freedom tests. Linear and logistic regressions will be used to assess the relationship between the number of minor alleles at each SNP with pharmacokinetic, toxicity and response parameters, as appropriate, in 1 degree of freedom tests.
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Assessment method [3]
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Timepoint [3]
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In the 4th year of the project
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Secondary outcome [1]
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Nil
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Assessment method [1]
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Timepoint [1]
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Nil
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Eligibility
Key inclusion criteria
Histologically/cytologically confirmed locally advanced, recurrent or metastatic colorectal adenocarcinoma not amenable to surgery or radiation therapy with curative intent, eligible for first-line or second-line chemotherapy with Irinotecan-5FU (FOLFIRI regimen or FOLFIRI-Bevacizumab [Avastin]); measurable or evaluable disease, adequate hepatic, bone marrow and renal function, Eastern Cooperative Oncology Group (ECOG) 2 or less, life expectancy greater than 12 weeks, written informed consent for the study and its associated procedures.
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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
Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the protocol or compromises the patient's ability to give informed consent.
Female patients who are pregnant or breast-feeding.
Any unresolved toxicity greater than NCI-CTC Grade 2 from previous anti-cancer therapy, active liver disease (e.g. chronic active hepatitis, cirrhosis), known diagnosis of human immunodeficiency virus (HIV) infection or Gilbert’s syndrome, prior severe reaction of fluoropyrimidine therapy, known sensitivity to 5-FU or deficit of dihydropyrimidine-dehydrogenase (DPD)
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
Data analysis is complete
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Reason for early stopping/withdrawal
Participant recruitment difficulties
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Date of first participant enrolment
Anticipated
1/11/2010
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Actual
22/02/2011
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Date of last participant enrolment
Anticipated
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Actual
19/01/2015
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Date of last data collection
Anticipated
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Actual
5/06/2015
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Sample size
Target
70
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Accrual to date
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Final
35
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment postcode(s) [1]
3303
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3002
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Recruitment postcode(s) [2]
3304
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3050
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Recruitment postcode(s) [3]
3305
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3084
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Recruitment postcode(s) [4]
3306
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3011
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Recruitment postcode(s) [5]
3307
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3128
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Recruitment postcode(s) [6]
3308
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3199
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Recruitment postcode(s) [7]
3309
0
5042
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Recruitment postcode(s) [8]
3310
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5011
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Recruitment postcode(s) [9]
3311
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2065
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Recruitment postcode(s) [10]
3312
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2217
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Recruitment postcode(s) [11]
3313
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2050
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Recruitment postcode(s) [12]
3328
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2139
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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National Health and Medical Research Council of Australia
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Address [1]
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Level 1
16 Marcus Clarke Street
Canberra ACT 2601
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Country [1]
257837
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Australia
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Primary sponsor type
Hospital
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Name
Peter MacCallum Cancer Centre
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Address
St Andrew's Place, East Melbourne, VIC, 3002
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Country
Australia
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Secondary sponsor category [1]
257048
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None
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Name [1]
257048
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Address [1]
257048
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Country [1]
257048
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Other collaborator category [1]
251559
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Individual
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Name [1]
251559
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Assoc Prof. Michael Jefford
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Address [1]
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Division of Haematology and Medical Oncology
Peter MacCallum Cancer Centre
St Andrew's Place, East Melbourne, 3002, VIC
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Country [1]
251559
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Australia
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Other collaborator category [2]
251560
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Individual
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Name [2]
251560
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Prof J Zalcberg
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Address [2]
251560
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Division of Haematology and Medical Oncology
Peter MacCallum Cancer Centre
St Andrew's Place, East Melbourne, 3002, VIC
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Country [2]
251560
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Australia
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Other collaborator category [3]
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Individual
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Name [3]
251561
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Dr C Cullinane
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Address [3]
251561
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Translational Research Laboratory
Peter MacCallum Cancer Centre
St Andrew's Place, East Melbourne, 3002, VIC
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Country [3]
251561
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Australia
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Other collaborator category [4]
251562
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Individual
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Name [4]
251562
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Assoc Prof Ian Campbell
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Address [4]
251562
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Cancer Genetics
Peter MacCallum Cancer Centre
St Andrew's Place, East Melbourne, 3002, VIC
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Country [4]
251562
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Australia
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Other collaborator category [5]
251563
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Individual
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Name [5]
251563
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Assoc Prof. N Tebbutt
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Address [5]
251563
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Dept of Medical Oncology
Austin Hospital
Studley Road, Heidelberg Heights, VIC, 3084
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Country [5]
251563
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Australia
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Other collaborator category [6]
251564
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Individual
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Name [6]
251564
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Prof A Scott
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Address [6]
251564
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Dept of Nuclear Medicine and Ludwig Institute
Studley Road, Heidelberg Heights, VIC, 3084
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Country [6]
251564
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Australia
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Other collaborator category [7]
251565
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Individual
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Name [7]
251565
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Assoc Prof L Lipton
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Address [7]
251565
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Medical Oncology and Clinical Haematology Unit
Western Hospital
Gordon Street, Footscray, VIC, 3011
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Country [7]
251565
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Australia
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Other collaborator category [8]
251566
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Individual
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Name [8]
251566
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Dr J Desai
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Address [8]
251566
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Dept of Medical Oncology
Peter MacCallum Cancer Centre
St Andrew's Place, East Melbourne, VIC, 3002
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Country [8]
251566
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Australia
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Other collaborator category [9]
251567
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Individual
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Name [9]
251567
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Dr Vinod Ganju
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Address [9]
251567
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Department of Medical Oncology
Peninsula Oncology Centre
24-28 Frankston-Flinders Road, Frankston, VIC, 3199
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Country [9]
251567
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Australia
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Other collaborator category [10]
251568
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Individual
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Name [10]
251568
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Dr Phillip Parente
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Address [10]
251568
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Department of Medical Oncology
Box Hill Hospital
Nelson Road, Box Hill, VIC, 3128
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Country [10]
251568
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Australia
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Other collaborator category [11]
251569
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Individual
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Name [11]
251569
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Assco Prof Joe McKendrick
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Address [11]
251569
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Department of Medical Oncology
Box Hill Hospital
Nelson Road, Box Hill, VIC, 3128
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Country [11]
251569
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Australia
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Other collaborator category [12]
251570
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Individual
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Name [12]
251570
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Assoc Prof Sue-Anne McLachlan
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Address [12]
251570
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St Vincent's Hospital
41 Victoria Parade, Fitzroy, VIC, 3065
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Country [12]
251570
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Australia
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Other collaborator category [13]
251571
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Individual
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Name [13]
251571
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Prof S Clarke
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Address [13]
251571
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Dept of Medicine and Medical Oncology
Concord Hospital
Hospital Road, Concord, NSW, 2139
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Country [13]
251571
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Australia
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Other collaborator category [14]
251572
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Individual
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Name [14]
251572
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Assoc Prof L Hovarth
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Address [14]
251572
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Dept of Medical Oncology
Royal Prince Alfred Hospital
Missenden Road, Camperdown, NSW, 2050
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Country [14]
251572
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Australia
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Other collaborator category [15]
251573
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Individual
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Name [15]
251573
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Dr W Liauw
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Address [15]
251573
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Dept of Medical Oncology
St Georges Hospital
Gray Street, Kogarah, NSW, 2217
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Country [15]
251573
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Australia
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Other collaborator category [16]
251574
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Individual
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Name [16]
251574
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Assoc Prof M Links
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Address [16]
251574
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Dept of Medical Oncology
Royal North Shore Hospital
Pacific Highway, St Leonards, NSW, 2065
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Country [16]
251574
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Australia
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Other collaborator category [17]
251575
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Individual
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Name [17]
251575
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Dr N Pavlakis
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Address [17]
251575
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Dept Medical Oncology
Queen Elizabeth Hospital
Woodville Road, Woodville, SA, 5011
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Country [17]
251575
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Australia
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Other collaborator category [18]
251576
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Individual
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Name [18]
251576
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Assoc Prof T Price
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Address [18]
251576
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Dept Medical Oncology
Flinders Medical Centre
Flinders Drive, Bedford Park, SA, 5042
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Country [18]
251576
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Australia
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Other collaborator category [19]
251577
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Individual
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Name [19]
251577
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Dr C Karapetis
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Address [19]
251577
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Dept of Medical Oncology
Flinders Medical Centre
Flinders Drive, Bedford Park, SA, 5042
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Country [19]
251577
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
259909
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Peter MacCallum Cancer Centre Ethics Committee
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Ethics committee address [1]
259909
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Level 4, 10 St Andrews Place
East Melbourne, Victoria, 3002
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Ethics committee country [1]
259909
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Australia
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Date submitted for ethics approval [1]
259909
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07/07/2010
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Approval date [1]
259909
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31/08/2010
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Ethics approval number [1]
259909
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PMCC Protocol No 10/55
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Summary
Brief summary
Observational pharmacology/pharmacogenomic/imaging study in patients receiving standard FOLFIRI ± Avastin for advanced incurable colorectal cancer.
Patients will undergo baseline nuclear hepatic functional imaging with IDA scans and bloods will be taken for metabolic/pharmacodynamic pharmacogenomics.
Bloods will be taken for Irinotecan PK in course 1.
Toxicities will be documented in the first 4 cycles and patients will be restaged at the end of cycle 4 (i.e. 8 weeks).
No trial involvement beyond 4 cycles is required and treatment beyond this point will be at the discretion of the treating clinician.
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Trial website
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Trial related presentations / publications
Abstract published in the ESMO 2017 Congress Abstract Book, a supplement to the official ESMO journal Annals of Oncology.
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Public notes
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Contacts
Principal investigator
Name
31773
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A/Prof Michael Michael
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Address
31773
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Peter MacCallum Cancer Centre
305 Grattan Street
Melbourne VIC 3000
Australia
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Country
31773
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Australia
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Phone
31773
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+61 3 8559 7860
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Fax
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Email
31773
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[email protected]
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Contact person for public queries
Name
15020
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A/Prof Assoc Prof M Michael
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Address
15020
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Division of Haematology and Medical Oncology
Peter MacCallum Cancer Centre
St Andrew's Place, East Melbourne, 3002, VIC
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Country
15020
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Australia
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Phone
15020
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+61 3 96561159
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Fax
15020
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+61 3 96561408
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Email
15020
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[email protected]
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Contact person for scientific queries
Name
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A/Prof Assoc Prof M Michael
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Address
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Division of Haematology and Medical Oncology
Peter MacCallum Cancer Centre
St Andrew's Place, East Melbourne, 3002, VIC
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Country
5948
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Australia
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Phone
5948
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+61 3 96561159
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Fax
5948
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+61 3 96561408
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Email
5948
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
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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