Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000264482
Ethics application status
Not required
Date submitted
14/02/2025
Date registered
10/04/2025
Date last updated
10/04/2025
Date data sharing statement initially provided
10/04/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
An investigation into the impact of plan characteristics on plan complexity measures in HyperArc Stereotactic Radiosurgery (SRS) plans
Scientific title
An investigation into the impact of plan characteristics on plan complexity measures in HyperArc Stereotactic Radiosurgery (SRS) plans treated at Canberra Hospital from September 2022 to December 2024.
Secondary ID [1] 313972 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
brain metastases 336692 0
Condition category
Condition code
Cancer 333193 333193 0 0
Brain

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
As this is a retrospective study using existing medical records of patients who have completed their course of radiation treatment from Sept 2022 to March 2025, there is no direct involvement from participants and no treatment is given to patients. The study will only use be using the existing radiation treatment plans and replanning them with different approaches/ parameters, then observing the correlation between plan complexity (monitor units) and physics plan quality assurance (QA) results. These different approaches/ parameters and therefore factors which will be investigated include number of lesions, shape and size of lesions, distance the lesions are from isocentre, proximity to healthy organs and whether additional optimisation structures were utilised.
Intervention code [1] 330559 0
Not applicable
Comparator / control treatment
Historical data consisting of Hyperarc SRS plans treated from September 2022 to March 2025.
Control group
Historical

Outcomes
Primary outcome [1] 340755 0
Change in total plan monitor units (MUs) when characteristics are varied in HyperArc SRS plans.
Timepoint [1] 340755 0
after replanning
Primary outcome [2] 340935 0
Change in physics quality assurance (QA) pass rates when characteristics are varied in HyperArc SRS plans.
Timepoint [2] 340935 0
after replanning and QA analysis.
Secondary outcome [1] 444999 0
Implementation of MU limits tailored to individual plan characteristics.
Timepoint [1] 444999 0
After data collection is complete and correlation is observed between plan characteristics and MUs + QA results.

Eligibility
Key inclusion criteria
Age: 18 years and older.
Diagnosis: intact brain metastases and/or post-operative cavities after resection of brain metastatic disease.
Patients planned with HyperArc and treated on the stereotactic linear accelerator at Canberra Region Cancer Centre from Sept 2022 to March 2025.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
14/02/2025
Date of last participant enrolment
Anticipated
30/04/2025
Actual
Date of last data collection
Anticipated
30/04/2025
Actual
Sample size
Target
149
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 318466 0
Hospital
Name [1] 318466 0
Canberra Hospital
Country [1] 318466 0
Australia
Primary sponsor type
Individual
Name
Helen Truong - Canberra Health Services
Address
Country
Australia
Secondary sponsor category [1] 320869 0
None
Name [1] 320869 0
Address [1] 320869 0
Country [1] 320869 0
Other collaborator category [1] 283438 0
Individual
Name [1] 283438 0
Helen Gustafsson - Canberra Health Services
Address [1] 283438 0
Country [1] 283438 0
Australia
Other collaborator category [2] 283439 0
Individual
Name [2] 283439 0
Rachel Poldy - Canberra Health Services
Address [2] 283439 0
Country [2] 283439 0
Australia
Other collaborator category [3] 283440 0
Individual
Name [3] 283440 0
Kimberley Legge- Canberra Health Services
Address [3] 283440 0
Country [3] 283440 0
Australia
Other collaborator category [4] 283441 0
Individual
Name [4] 283441 0
Martin Seng- Canberra Health Services
Address [4] 283441 0
Country [4] 283441 0
Australia
Other collaborator category [5] 283442 0
Individual
Name [5] 283442 0
Farhan Syed- Canberra Health Services
Address [5] 283442 0
Country [5] 283442 0
Australia

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 317081 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 317081 0
Ethics committee country [1] 317081 0
Australia
Date submitted for ethics approval [1] 317081 0
14/02/2025
Approval date [1] 317081 0
Ethics approval number [1] 317081 0

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

Contacts
Principal investigator
Name 139942 0
Ms Helen Truong
Address 139942 0
Canberra Region Cancer Centre, Building 19, The Canberra Hospital - Bateson Road, Garran ACT 2605
Country 139942 0
Australia
Phone 139942 0
+61 02 51248444
Fax 139942 0
Email 139942 0
[email protected]
Contact person for public queries
Name 139943 0
Helen Truong
Address 139943 0
Canberra Region Cancer Centre, Building 19, The Canberra Hospital - Bateson Road, Garran ACT 2605
Country 139943 0
Australia
Phone 139943 0
+61 02 51248444
Fax 139943 0
Email 139943 0
[email protected]
Contact person for scientific queries
Name 139944 0
Helen Truong
Address 139944 0
Canberra Region Cancer Centre, Building 19, The Canberra Hospital - Bateson Road, Garran ACT 2605
Country 139944 0
Australia
Phone 139944 0
+61 02 51248444
Fax 139944 0
Email 139944 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.