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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04658537




Registration number
NCT04658537
Ethics application status
Date submitted
24/11/2020
Date registered
8/12/2020

Titles & IDs
Public title
Advanced Techniques for Single-fraction Palliative Radiotherapy Versus ASPIRE-single
Scientific title
Advanced Techniques for Single-fraction Palliative Radiotherapy Versus Standard Single Fraction Radiation
Secondary ID [1] 0 0
ASPIRE-single
Universal Trial Number (UTN)
Trial acronym
ASPIRE single
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Palliative Radiotherapy 0 0
Radiotherapy, Intensity-Modulated 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Radiation Therapy

Active comparator: Standard Arm - 8 Gy / 1 Fraction

Experimental: Single Fraction Dose Escalation - 8Gy Planning Target Volume / 12Gy Clinical Target Volume +/- 14Gy Gross Tumour Volume / 1 fraction


Treatment: Other: Radiation Therapy
Cancer treatment that uses high doses of radiation to kill cancer cells and shrink tumours
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Substantial benefit from palliative radiotherapy
Timepoint [1] 0 0
9 months
Secondary outcome [1] 0 0
Treatment Wait Time
Timepoint [1] 0 0
1 week
Secondary outcome [2] 0 0
Radiation Department Time
Timepoint [2] 0 0
1 day
Secondary outcome [3] 0 0
Radiotherapy Treatment Time
Timepoint [3] 0 0
1 day
Secondary outcome [4] 0 0
Completion Rates of ePRO's in a Palliative Care Cohort
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
Comparing Patient and Carer Assessments
Timepoint [5] 0 0
2 years
Secondary outcome [6] 0 0
Radiation Doses to Organs at Risk
Timepoint [6] 0 0
2 years
Secondary outcome [7] 0 0
Patient Reported Outcomes
Timepoint [7] 0 0
24 months
Secondary outcome [8] 0 0
Carer Reported Outcomes
Timepoint [8] 0 0
24 months
Secondary outcome [9] 0 0
Efficacy of treatment
Timepoint [9] 0 0
2 years
Secondary outcome [10] 0 0
Overall Survival
Timepoint [10] 0 0
2 years

Eligibility
Key inclusion criteria
* Metastatic cancer
* Recommended for 8Gy/1# 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 multi 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
29/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2024
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
Department of Radiation Oncology, 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
Dylan J Chin
Address 0 0
Country 0 0
Phone 0 0
+612 9463 1337
Fax 0 0
Email 0 0
dylan.chin@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)?
Yes
What data in particular will be shared?
The results of this trial will be published in a peer reviewed journal. Target journals for publication of this trial include, International Journal of Radiation Oncology Biology Physics
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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/NCT04658537