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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04649125
Registration number
NCT04649125
Ethics application status
Date submitted
24/11/2020
Date registered
2/12/2020
Titles & IDs
Public title
Advanced Techniques For Single-fraction Palliative Radiotherapy Versus Standard Multi Fraction Radiation
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Scientific title
Advanced Techniques For Single-fraction Palliative Radiotherapy Versus Standard Multi Fraction Radiation
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Secondary ID [1]
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ASPIRE Multi
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Universal Trial Number (UTN)
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Trial acronym
ASPIRE_Multi
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Palliative Radiotherapy
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - dose escalation
Active comparator: standard - standard radiotherapy 5 fractions
Experimental: single fraction dose escalation - 8Gy to Planned Target Volume, 12Gy to Clinical Target Volume +/- 14Gy to Gross Target Volume
Treatment: Other: dose escalation
single fraction dose escalation to the tumour
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Intervention code [1]
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Treatment: Other
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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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benefit from palliative radiotherapy
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Assessment method [1]
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to determine the percentage of patients who have achieved a substantial benefit from palliative radiotherapy and have not redeveloped symptoms by 9 months post treatment
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Timepoint [1]
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9 months
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Secondary outcome [1]
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Feasibility of the trial
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Assessment method [1]
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This will be assessed by the treatment wait time, the amount of time spent in the Radiation Department, the completion rates of electronic Patient Reported Outcome (ePRO)'s and comparing patient and carer assessments
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Timepoint [1]
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2 years
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Secondary outcome [2]
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Trial Safety
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Assessment method [2]
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this will be determined by the radiation dose delivered to organs at risk and patient and carer reported toxicity from treatment
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Timepoint [2]
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2 years
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Secondary outcome [3]
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Efficacy of treatment
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Assessment method [3]
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Efficacy will be determined by reported treatment benefit, pain response, symptom control,re-treatment rates, overall survival and patient and carer regret
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Timepoint [3]
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2 years
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Eligibility
Key inclusion criteria
* Metastatic cancer
* Recommended for 5-10 fractions palliative radiation
* Patients with spinal cord compression are eligible for enrolment
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Minimum age
No limit
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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
* Unwilling or unable to give informed consent
* Patients who are recommended for single fraction palliative radiation
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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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
31/05/2021
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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
30/06/2025
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Royal North Shore Hospital - Saint Leonards
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Recruitment postcode(s) [1]
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2065 - Saint Leonards
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Funding & Sponsors
Primary sponsor type
Other
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Name
Royal North Shore Hospital
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The aim of the study is to determine if single fraction dose escalated palliative radiotherapy results in a prolonged duration of benefit for patients otherwise suitable for Multifraction (5-10#) palliative radiation. The primary endpointis to determine the percentage of patients who have achieved a substantial benefit from palliative radiotherapy and have not redeveloped symptoms by 12 months post treatment
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Trial website
https://clinicaltrials.gov/study/NCT04649125
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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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Thomas Eade
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Address
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Northern Sydney Cancer Centre, Royal North Shore Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Carol Kwong, RN
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Address
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Country
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Phone
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+61294631339
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
The results of this trial will be published in a peer reviewed journal.
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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 not provided in
https://clinicaltrials.gov/study/NCT04649125