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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01001377
Registration number
NCT01001377
Ethics application status
Date submitted
22/10/2009
Date registered
26/10/2009
Date last updated
21/09/2022
Titles & IDs
Public title
ASPECCT: A Study of Panitumumab Efficacy and Safety Compared to Cetuximab in Patients With KRAS Wild-Type Metastatic Colorectal Cancer
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Scientific title
A Randomized, Multicenter, Open-label, Phase 3 Study to Compare the Efficacy and Safety of Panitumumab and Cetuximab in Subjects With Previously Treated, Wild-type KRAS, Metastatic Colorectal Cancer
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Secondary ID [1]
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0
ASPECCT
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Secondary ID [2]
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20080763
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Colorectal Cancer
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0
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Condition category
Condition code
Cancer
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0
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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
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Cetuximab
Treatment: Drugs - Panitumumab
Active comparator: Cetuximab - Cetuximab 400 mg/m\^2 as an initial dose, followed by 250 mg/m\^2 intravenously (IV) every 7 days.
Participants were treated until disease progression, intolerability, withdrawal of consent, or death.
Experimental: Panitumumab - Panitumumab 6 mg/kg IV every 14 days. Participants were treated until disease progression, intolerability, withdrawal of consent, or death.
Treatment: Drugs: Cetuximab
Administered by intravenous infusion
Treatment: Drugs: Panitumumab
Administered by intravenous infusion
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Intervention code [1]
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0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival
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Assessment method [1]
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Overall survival is the time from the date of randomization until the date of death. Participants who had not died by the analysis data cut-off date were censored at their last contact date.
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Timepoint [1]
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From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
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Secondary outcome [1]
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Progression-free Survival
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Assessment method [1]
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Progression free survival (PFS) is the time from the date of randomization to the date of disease progression per the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death. Participants alive and not meeting criteria for progression by the analysis data cut-off date were censored at their last evaluable disease assessment date.
Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study based on all target lesions recorded since the treatment started (the sum must also demonstrate an absolute increase of at least 5 mm), or unequivocal progression of existing non-target lesions, or any new lesions.
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Timepoint [1]
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From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
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Secondary outcome [2]
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Objective Response
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Assessment method [2]
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Objective response is either a complete response (CR) or partial response (PR) per RECIST version 1.1. All participants that did not meet the criteria for an objective response by the analysis cut-off date were considered non-responders. CR: Disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm, and disappearance of all non-target lesions, and no new lesions. PR: Disappearance of all target lesions, persistence of one or more non-target lesions not qualifying for either CR or progressive disease, or, at least a 30% decrease in the sum of diameters of target lesions with no unequivocal progression of existing non-target lesions and no new lesions.
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Timepoint [2]
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From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
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Secondary outcome [3]
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Duration of Response
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Assessment method [3]
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Duration of response (DOR), calculated only for those participants with an objective response, is the time from first objective response to disease progression per the RECIST v1.1 or death. Participants not meeting criteria for progression or who died by the analysis data cutoff date were censored at their last evaluable disease assessment date.
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Timepoint [3]
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From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
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Secondary outcome [4]
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Time to Response
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Assessment method [4]
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Time to response (TTR), calculated for those participants with an objective response, is defined as the time from the randomization date to the date of first objective response.
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Timepoint [4]
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From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
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Secondary outcome [5]
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Time to Treatment Failure
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Assessment method [5]
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Time to treatment failure (TTF) is the time from randomization date to date that the decision was made to end the treatment period for any reason; participants who remained in the treatment period at the time of analysis were censored at the date of the last on-study assessment.
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Timepoint [5]
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From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.
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Secondary outcome [6]
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Change From Baseline in EuroQOL 5 Dimension (EQ-5D) Health State Index Score
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Assessment method [6]
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The EQ-5D is a standardized instrument for use as a generic measure of health outcome. The health state index measures the following 5 health dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension contains 3 levels of response to reflect degree of problems participants have experienced: no problem (1), some problem (2) and extreme problems (3). The health states for each respondent are converted into a single index number using a specified set of weights. Resulting scores can range from 1.0 and -0.594. A higher score indicates a more preferred health status with 1.0 representing perfect health and 0 representing death. Negative scores are possible and represent health states regarded as less preferable than death (0). Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and participants a random effect.
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Timepoint [6]
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From Study Day 1 through the last day of treatment or disease progression, up to Week 85.
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Secondary outcome [7]
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Change From Baseline in EuroQOL 5 Dimension (EQ-5D) Visual Analog Scale (VAS)
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Assessment method [7]
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The EQ-5D is a standardized instrument for use as a generic measure of health outcome. The VAS asks respondents to rate their present health status on a 0 - 100 scale, with 0 labeled as "Worst imaginable health state" and 100 labeled as "Best imaginable health state." The VAS score is determined by observing the point at which the participant's hand drawn line intersects the scale.
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Timepoint [7]
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From Study Day 1 through the last day of treatment or disease progression, up to Week 85.
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Secondary outcome [8]
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Change From Baseline in National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Colorectal Symptom Index (NCCN FCSI ) Symptoms Score
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Assessment method [8]
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The FCSI consists of 9 questions comprising the most important symptoms associated with colorectal cancer, including energy, pain, weight, diarrhea, nausea, swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. The 9 questions are combined in three algorithms to provide information for 3 domains: colorectal cancer symptoms, physical well-being, and functional well-being. Each of the 9 items are scored from "0" to "4" representing "Not at All" through to "Very Much True". The raw score for all items is transformed to a 0-100 scale, and the average for each of the 3 subscales is calculated; high scores illustrate an improved state (e.g. able to enjoy life more).
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Timepoint [8]
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From Study Day 1 through the last day of treatment or disease progression, up to Week 85.
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Secondary outcome [9]
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Change From Baseline in NCCN FCSI Physical Well-being Scale Score
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Assessment method [9]
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The FCSI consists of 9 questions comprising the most important symptoms associated with colorectal cancer, including energy, pain, weight, diarrhea, nausea, swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. The 9 questions are combined in three algorithms to provide information for 3 domains: colorectal cancer symptoms, physical well-being, and functional well-being. Each of the 9 items are scored from "0" to "4" representing "Not at All" through to "Very Much True". The raw score for all items is transformed to a 0-100 scale, and the average for each of the 3 subscales is calculated; high scores illustrate an improved state (e.g. able to enjoy life more).
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Timepoint [9]
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From Study Day 1 through the last day of treatment or disease progression, up to Week 85.
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Secondary outcome [10]
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Change From Baseline in NCCN FCSI Functional Well-being Scale Score
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Assessment method [10]
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The FCSI consists of 9 questions comprising the most important symptoms associated with colorectal cancer, including energy, pain, weight, diarrhea, nausea, swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. The 9 questions are combined in three algorithms to provide information for 3 domains: colorectal cancer symptoms, physical well-being, and functional well-being. Each of the 9 items are scored from "0" to "4" representing "Not at All" through to "Very Much True". The raw score for all items is transformed to a 0-100 scale, and the average for each of the 3 subscales is calculated; high scores illustrate an improved state (e.g. able to enjoy life more).
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Timepoint [10]
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From Study Day 1 through the last day of treatment or disease progression, up to Week 85.
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Secondary outcome [11]
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Number of Participants With Adverse Events (AEs)
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Assessment method [11]
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Serious adverse events include any event that is fatal, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or other significant medical hazard. Treatment-related AEs are those the investigator considered as a reasonable possibility to have been caused by study drug.
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Timepoint [11]
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From the day of the first dose of study therapy through 30 days since the last dose. Maximum time on study treatment was 130 weeks.
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Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon or rectum, metastatic disease
* Wild-type KRAS tumor status
* Eastern Cooperative Oncology Group (ECOG) score of 0, 1 or 2
* Must have failed a prior regimen containing irinotecan for metastatic disease and a prior regimen containing oxaliplatin for metastatic disease
* Must have previously received a thymidylate synthase inhibitor (eg, fluorouracil, capecitabine, raltitrexed, or fluorouracil-uracil) at any point for treatment of colorectal cancer (CRC)
* Adequate hematologic, renal, hepatic and metabolic function
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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
* Symptomatic brain metastases requiring treatment
* Prior anti-epidermal growth factor receptor (EGFr) antibody therapy (eg, panitumumab or cetuximab) or treatment with small molecule EGFr inhibitors (eg, gefitinib, erlotinib, lapatinib)
* Antitumor therapy (eg, chemotherapy, hormonal therapy, immunotherapy, antibody therapy, radiotherapy), or investigational agent or therapy = 30 days before randomization.
* Clinically significant cardiovascular disease
* Active infection requiring systemic treatment or any uncontrolled infection =14 days prior to randomization
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled 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
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/02/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
7/03/2017
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Sample size
Target
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Accrual to date
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Final
1010
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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0
Research Site - Liverpool
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Recruitment hospital [2]
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Research Site - St Leonards
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Recruitment hospital [3]
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Research Site - Wahroonga
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Recruitment hospital [4]
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Research Site - Wollongong
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Recruitment hospital [5]
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Research Site - Woodville South
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Recruitment hospital [6]
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Research Site - Ballarat
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Recruitment hospital [7]
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Research Site - Box Hill
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Recruitment hospital [8]
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Research Site - Epping
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Recruitment hospital [9]
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Research Site - Footscray
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Recruitment hospital [10]
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Research Site - Heidelberg
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Recruitment hospital [11]
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Research Site - Parkville
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Recruitment postcode(s) [1]
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2170 - Liverpool
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Recruitment postcode(s) [2]
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2065 - St Leonards
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Recruitment postcode(s) [3]
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2076 - Wahroonga
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Recruitment postcode(s) [4]
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2500 - Wollongong
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Recruitment postcode(s) [5]
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5011 - Woodville South
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Recruitment postcode(s) [6]
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3350 - Ballarat
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Recruitment postcode(s) [7]
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3128 - Box Hill
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Recruitment postcode(s) [8]
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3076 - Epping
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Recruitment postcode(s) [9]
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3011 - Footscray
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Recruitment postcode(s) [10]
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3084 - Heidelberg
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Recruitment postcode(s) [11]
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3050 - Parkville
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Florida
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United States of America
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State/province [3]
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Kansas
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United States of America
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State/province [4]
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Texas
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Country [5]
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United States of America
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State/province [5]
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Utah
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Country [6]
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Belgium
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State/province [6]
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Edegem
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Country [7]
0
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Bulgaria
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State/province [7]
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Sofia
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Country [8]
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Canada
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State/province [8]
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Alberta
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Country [9]
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Canada
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State/province [9]
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Nova Scotia
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Country [10]
0
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China
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State/province [10]
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Guangdong
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Country [11]
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China
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State/province [11]
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Heilongjiang
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Country [12]
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China
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State/province [12]
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Hunan
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China
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State/province [13]
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Jiangsu
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Country [14]
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China
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State/province [14]
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Jilin
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China
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Shaanxi
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China
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Shanghai
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China
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Sichuan
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China
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Zhejiang
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China
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Beijing
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China
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State/province [20]
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Tianjin
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Czechia
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Horovice
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Czechia
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State/province [22]
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Nova Ves pod Plesi
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Czechia
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Olomouc
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Czechia
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State/province [24]
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Praha 10
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Czechia
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State/province [25]
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Pribram
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Czechia
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State/province [26]
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Znojmo
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France
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State/province [27]
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Besançon Cedex
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France
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State/province [28]
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Montbéliard
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France
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Saint Brieuc
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France
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Saint Herblain
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France
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Villejuif cedex
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Hong Kong
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Kowloon
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Hong Kong
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New Territories
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Andhra Pradesh
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India
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Kerala
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India
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Maharashtra
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India
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Rajasthan
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India
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Tamil Nadu
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India
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West Bengal
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Israel
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Beer Sheva
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Israel
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Jerusalem
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Israel
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Kfar Saba
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Israel
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Ramat Gan
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Israel
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Rehovot
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Italy
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Ancona
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Italy
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Cesena
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Italy
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Cremona
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Italy
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Faenza RA
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Italy
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Genova
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Italy
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Lugo
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Italy
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Meldola FC
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Italy
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Ravenna
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Italy
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Rimini
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Italy
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Torino
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Korea, Republic of
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Goyang-si, Gyeonggi-do
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Korea, Republic of
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Seoul
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Latvia
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Daugavpils
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Latvia
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Riga
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Lithuania
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Kaunas
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Lithuania
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Vilnius
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Malaysia
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Kelantan
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Malaysia
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Sabah
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Malaysia
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Wilayah Persekutuan
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Netherlands
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Rotterdam
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Peru
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Lima
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Philippines
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Cebu City
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Philippines
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Manila
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Philippines
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Quezon City
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Poland
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Elblag
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Poland
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Gdansk
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Poland
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Jelenia Gora
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Poland
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Poznan
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Poland
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Szczecin
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Poland
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Warszawa
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Romania
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Bucharest
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Romania
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Sibiu
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Russian Federation
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Moscow
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Russian Federation
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Saint Petersburg
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Russian Federation
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Saint-Petersburg
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Serbia
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Nis
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Serbia
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Sremska Kamenica
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Singapore
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Singapore
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Slovakia
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Bardejov
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Sweden
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Sutton
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Wolverhampton
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Funding & Sponsors
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Commercial sector/industry
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Name
Amgen
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Summary
Brief summary
The primary objective of this study is to compare the effect of panitumumab versus cetuximab on overall survival (OS) for chemorefractory metastatic colorectal cancer (mCRC) among patients with wild-type Kirsten rat Sarcoma-2 virus (KRAS) tumors.
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Trial website
https://clinicaltrials.gov/study/NCT01001377
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Trial related presentations / publications
Price T, Kim TW, Li J, Cascinu S, Ruff P, Suresh AS, Thomas A, Tjulandin S, Guan X, Peeters M. Final results and outcomes by prior bevacizumab exposure, skin toxicity, and hypomagnesaemia from ASPECCT: randomized phase 3 non-inferiority study of panitumumab versus cetuximab in chemorefractory wild-type KRAS exon 2 metastatic colorectal cancer. Eur J Cancer. 2016 Nov;68:51-59. doi: 10.1016/j.ejca.2016.08.010. Epub 2016 Oct 5. Price TJ, Peeters M, Kim TW, Li J, Cascinu S, Ruff P, Suresh AS, Thomas A, Tjulandin S, Zhang K, Murugappan S, Sidhu R. Panitumumab versus cetuximab in patients with chemotherapy-refractory wild-type KRAS exon 2 metastatic colorectal cancer (ASPECCT): a randomised, multicentre, open-label, non-inferiority phase 3 study. Lancet Oncol. 2014 May;15(6):569-79. doi: 10.1016/S1470-2045(14)70118-4. Epub 2014 Apr 14. Kim TW, Peeters M, Thomas A, Gibbs P, Hool K, Zhang J, Ang AL, Bach BA, Price T. Impact of Emergent Circulating Tumor DNA RAS Mutation in Panitumumab-Treated Chemoresistant Metastatic Colorectal Cancer. Clin Cancer Res. 2018 Nov 15;24(22):5602-5609. doi: 10.1158/1078-0432.CCR-17-3377. Epub 2018 Jun 13. Peeters M, Price T, Boedigheimer M, Kim TW, Ruff P, Gibbs P, Thomas A, Demonty G, Hool K, Ang A. Evaluation of Emergent Mutations in Circulating Cell-Free DNA and Clinical Outcomes in Patients with Metastatic Colorectal Cancer Treated with Panitumumab in the ASPECCT Study. Clin Cancer Res. 2019 Feb 15;25(4):1216-1225. doi: 10.1158/1078-0432.CCR-18-2072. Epub 2018 Nov 28. Price T, Ang A, Boedigheimer M, Kim TW, Li J, Cascinu S, Ruff P, Satya Suresh A, Thomas A, Tjulandin S, Peeters M. Frequency of S492R mutations in the epidermal growth factor receptor: analysis of plasma DNA from patients with metastatic colorectal cancer treated with panitumumab or cetuximab monotherapy. Cancer Biol Ther. 2020 Oct 2;21(10):891-898. doi: 10.1080/15384047.2020.1798695. Epub 2020 Oct 7. Taniguchi H, Yamanaka T, Sakai D, Muro K, Yamazaki K, Nakata S, Kimura H, Ruff P, Kim TW, Peeters M, Price T. Efficacy of Panitumumab and Cetuximab in Patients with Colorectal Cancer Previously Treated with Bevacizumab; a Combined Analysis of Individual Patient Data from ASPECCT and WJOG6510G. Cancers (Basel). 2020 Jun 28;12(7):1715. doi: 10.3390/cancers12071715. Graham CN, Maglinte GA, Schwartzberg LS, Price TJ, Knox HN, Hechmati G, Hjelmgren J, Barber B, Fakih MG. Economic Analysis of Panitumumab Compared With Cetuximab in Patients With Wild-type KRAS Metastatic Colorectal Cancer That Progressed After Standard Chemotherapy. Clin Ther. 2016 Jun;38(6):1376-1391. doi: 10.1016/j.clinthera.2016.03.023. Epub 2016 Apr 13.
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Public notes
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Contacts
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MD
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Amgen
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01001377
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