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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
Scientific title
Advanced Techniques For Single-fraction Palliative Radiotherapy Versus Standard Multi Fraction Radiation
Secondary ID [1] 0 0
ASPIRE Multi
Universal Trial Number (UTN)
Trial acronym
ASPIRE_Multi
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Palliative Radiotherapy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
benefit from palliative radiotherapy
Timepoint [1] 0 0
9 months
Secondary outcome [1] 0 0
Feasibility of the trial
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
Trial Safety
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Efficacy of treatment
Timepoint [3] 0 0
2 years

Eligibility
Key inclusion criteria
* Metastatic cancer
* Recommended for 5-10 fractions palliative radiation
* Patients with spinal cord compression are eligible for enrolment
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Unwilling or unable to give informed consent
* Patients who are recommended for single fraction palliative radiation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal North Shore Hospital - Saint Leonards
Recruitment postcode(s) [1] 0 0
2065 - Saint Leonards

Funding & Sponsors
Primary sponsor type
Other
Name
Royal North Shore Hospital
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Thomas Eade
Address 0 0
Northern Sydney Cancer Centre, Royal North Shore Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Carol Kwong, RN
Address 0 0
Country 0 0
Phone 0 0
+61294631339
Fax 0 0
Email 0 0
carolyn.kwong@health.nsw.gov.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
The results of this trial will be published in a peer reviewed journal.


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