Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04649125




Registration number
NCT04649125
Ethics application status
Date submitted
24/11/2020
Date registered
2/12/2020
Date last updated
18/11/2023

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
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT04649125
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04649125