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Trial registered on ANZCTR


Registration number
ACTRN12616000987460
Ethics application status
Approved
Date submitted
25/07/2016
Date registered
27/07/2016
Date last updated
27/07/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of the CARG Toxicity Score versus clinician estimate for predicting the risk of chemotherapy toxicity in older adults with cancer.
Scientific title
Optimising treatment decisions for the older adult with cancer: CARG Toxicity Score versus clinician-estimate for predicting the risk of chemotherapy toxicity in older adults with cancer
Secondary ID [1] 289721 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chemotherapy toxicity 299554 0
cancer 299555 0
Condition category
Condition code
Cancer 299528 299528 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Geriatric assessment and calculation of CARG Toxicity Score. This involves a face-to-face health questionnaire with the participant performed by a study researcher and takes no longer than 30 minutes. Health domains covered as part of the geriatric assessment include functional status, comorbidity, history of falls, cognition, nutrition, psychosocial health and a timed walk test. The geriatric assessment is performed in the outpatient clinic area on one occasion prior to the participant commencing treatment with chemotherapy. The treating oncologist is asked to nominate for each patient their estimate of the likelihood of severe chemotherapy toxicity over the course of treatment, and make an assessment of the patient's clinical frailty status and performance status. For Part 1 of the study, the treating oncologist is not made aware of the results of the geriatric assessment and CARG Toxicity Score, but results are recorded by study researchers. Participants are followed throughout their chemotherapy course to observe for severe chemotherapy-related toxicity and treatment deliverability (unplanned hospital admissions, dose modifications).

After target accrual for Part 1 of the study, transition will be made to Part 2, where results of the geriatric assessment and CARG Toxicity Score will be presented to the treating oncologist prior to the patient commencing chemotherapy. The treating oncologist will complete a questionnaire, taking no more than 10 minutes, addressing how useful they found the provided information from the geriatric assessment, if it provided them with new information above their usual clinical assessment, and if they would modify their proposed treatment plan or employ any additional interventions based on the results. The treating oncologist may amend their planned care plan for the patient at their own discretion.
Intervention code [1] 295356 0
Other interventions
Comparator / control treatment
All participants undergo usual clinical assessment by their treating oncologist, from which the oncologist is asked to rate the likelihood of the occurrence of severe chemotherapy toxicity. The predictive value of this estimate is compared to the geriatric assessment and CARG Toxicity Score.
Control group
Active

Outcomes
Primary outcome [1] 299008 0
Grade 3 to 5 treatment-related toxicity by NCI CTCAE v4.0
Timepoint [1] 299008 0
Over the course of planned chemotherapy treatment, to a maximum of 12 months.
Secondary outcome [1] 325855 0
Grade 1 to 5 non-haematologic toxicity as defined by NCI CTCAE v4.0
Timepoint [1] 325855 0
Over the course of planned chemotherapy, to a maximum of 12 months
Secondary outcome [2] 325856 0
Chemotherapy deliverability as measured by number of dose modifications, treatment cessation due to toxicity
Timepoint [2] 325856 0
Over the course of planned treatment to a maximum of 12 months.
Secondary outcome [3] 325857 0
Unplanned hospital admissions as assessed by review of medical records and a standardised follow up toxicity form
Timepoint [3] 325857 0
Over the course of planned treatment to a maximum of 12 months
Secondary outcome [4] 325858 0
Survival
Timepoint [4] 325858 0
Captured at 12 months from study enrolment

Eligibility
Key inclusion criteria
Age 65 years or older
Clinical, radiological or histopathological diagnosis of malignancy, any stage
Seen by a medical oncologist in the outpatient setting
Due to start a new line of systemic cytotoxic chemotherapy
Sufficient English proficiency to complete study assessments
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Concurrent radiotherapy
Use of PD-1 treatment alone or in combination with chemotherapy
Use of single agent targeted therapies

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
Descriptive statistics will be used to describe the patient population using frequencies and proportions (%) for categorical variables and mean (SD) and median (IQR) for continuous variables. Univariate and multivariate logistic regression will be used to explore potential associations between toxicity and covariates. Receiver-Operator Characteristic (ROC) curves will be used to summarise the predictive performance of individual quantitative covariates, and risk scores from multivariate logistic regression models. Overall survival (OS) will be calculated from the date of the first study consultation with the oncologist (when oncologist’s survival estimate is made) until death or last known follow-up. The Kaplan-Meier method will be used to summarise OS, and proportional hazards regression will be used to evaluate predictors of OS. A study of N=100 would have approximately 90% power at the two-sided 5% level of statistical significance to identify, using logistic regression modelling, a two-fold increase in the odds of a grade 3+ toxicity for every one standard deviation increase in CARG risk score assuming the underlying prevalence of grade 3+ toxicity is 50%. Part 2 of the study is exploratory. A sample size of N = 50 would provide for estimated proportions of 20% a given confidence interval of approximately 11%.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
17/08/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 6228 0
Concord Repatriation Hospital - Concord
Recruitment hospital [2] 6229 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment postcode(s) [1] 13645 0
2139 - Concord
Recruitment postcode(s) [2] 13646 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 294136 0
Government body
Name [1] 294136 0
Sydney Local Health District Cancer Services Research Grant
Country [1] 294136 0
Australia
Funding source category [2] 294137 0
Other Collaborative groups
Name [2] 294137 0
Sydney Catalyst Translational Cancer Research
Country [2] 294137 0
Australia
Primary sponsor type
Individual
Name
Dr Erin Moth
Address
Building 76
Concord Repatriation General Hospital
Hospital Road
CONCORD NSW 2137
Country
Australia
Secondary sponsor category [1] 292966 0
None
Name [1] 292966 0
Address [1] 292966 0
Country [1] 292966 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295549 0
Sydney Local Health District HREC - Concord Repatriation General Hospital
Ethics committee address [1] 295549 0
Ethics committee country [1] 295549 0
Australia
Date submitted for ethics approval [1] 295549 0
18/05/2015
Approval date [1] 295549 0
28/07/2015
Ethics approval number [1] 295549 0
HREC/15/CRGH/102

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67574 0
Dr Prunella Blinman
Address 67574 0
c/o Concord Cancer Centre
Building 76
Concord Repatriation General Hospital
Hospital Road
CONCORD NSW 2137
Country 67574 0
Australia
Phone 67574 0
+61297676354
Fax 67574 0
Email 67574 0
prunella.blinman@sswahs.nsw.gov.au
Contact person for public queries
Name 67575 0
Erin Moth
Address 67575 0
c/o Concord Cancer Centre
Building 76
Concord Repatriation General Hospital
Hospital Road, CONCORD NSW 2137
Country 67575 0
Australia
Phone 67575 0
+61297676354
Fax 67575 0
Email 67575 0
erin.moth@sswahs.nsw.gov.au
Contact person for scientific queries
Name 67576 0
Prunella Blinman
Address 67576 0
c/o Concord Cancer Centre
Building 76
Concord Repatriation General Hospital
Hospital Road
CONCORD NSW 2137
Country 67576 0
Australia
Phone 67576 0
+61297676354
Fax 67576 0
Email 67576 0
prunella.blinman@sswahs.nsw.gov.au

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.