Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000254493
Ethics application status
Approved
Date submitted
3/02/2025
Date registered
16/03/2025
Date last updated
16/03/2025
Date data sharing statement initially provided
16/03/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the impact of normal tissue objectives in treatment planning for stereotactic body radiation therapy
Scientific title
Investigating the impact of normal tissue objectives in treatment planning for stereotactic body radiation therapy in patients treated with nodal/bone and lung metastasis.
Secondary ID [1] 313867 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bone metastases 336636 0
Lung metastases 336637 0
Nodal metastases 336534 0
Oligometastases 336638 0
Condition category
Condition code
Cancer 333135 333135 0 0
Malignant melanoma
Cancer 333134 333134 0 0
Lung - Non small cell
Cancer 333047 333047 0 0
Bone

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Ten lung and ten nodal/bone metastasis stereotactic body radiation therapy (SBRT) plans that were previously treated at our institution from July 2022 until December 2024 will be randomly selected and anonymised. There will be no direct involvement from patients as the study is collecting data retrospectively from existing medical records, and therefore, no treatment given to participants as they have already finished their course of treatment - only their datasets and plans will be used for the study.

The study may include patients with one or two targets. The de-identified datasets of the selected patients and corresponding plans will be sent to an Eclipse v18.0 test system where they will be replanned using the SBRT normal tissue objective (NTO) feature by the Principal Investigator (PI).

The plans will maintain all parameters, such as arc arrangement, constant. The sole modification will involve changing the NTO setting from our manually optimised settings to the SBRT NTO within the optimiser. All plans will be optimised in ‘automatic mode’ with an intermediate dose calculation using the Acuros calculation algorithm. The optimiser will not be paused during optimisation nor re-optimised following final dose calculation.


Intervention code [1] 330457 0
Not applicable
Comparator / control treatment
Original plans which used the conventional SBRT NTO settings which will be gathered from existing patient medical records from July 2022 to December 2024.
Control group
Historical

Outcomes
Primary outcome [1] 340591 0
The primary outcome is a change in conformity index (CI100) for lung and nodal/bone metastasis SBRT plans against standard department NTO settings.
Timepoint [1] 340591 0
Post replanning
Primary outcome [2] 340792 0
The primary outcome is a change in maximum dose 2cm away from PTV (D2cm) for lung and nodal/bone metastasis SBRT plans against standard department NTO settings.
Timepoint [2] 340792 0
Post replanning.
Primary outcome [3] 340793 0
The primary outcome is a change in monitor units for lung and nodal/bone metastasis SBRT plans against standard department NTO settings.
Timepoint [3] 340793 0
post replanning.
Secondary outcome [1] 445093 0
The secondary outcome is a change in lung volume of >20Gy (V20Gy) if applicable, and/or a change in other healthy organ doses which are in close proximity for lung and nodal/bone metastasis SBRT plans against standard department NTO settings.
Timepoint [1] 445093 0
Post replanning
Secondary outcome [2] 444540 0
The secondary outcome is the change in time taken when planning SBRT lung and bone/nodal cases with SBRT NTO.
Timepoint [2] 444540 0
Post replanning
Secondary outcome [3] 445453 0
The secondary outcome is a change in ratio of the 50% prescription isodose volume to PTV (CI50) for lung and nodal/bone metastasis SBRT plans against standard department NTO settings.
Timepoint [3] 445453 0
Post replanning

Eligibility
Key inclusion criteria
Treated for SBRT nodal/ bone and lung metastasis from July 2022 to December 2024.
SBRT volumes containing 1 or 2 targets.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Duration
Selection
Random sample
Timing
Both
Statistical methods / analysis
Descriptive statistics will be used for the analysis of data collected from this study. It is anticipated that most results will be presented using basic statistics (percentages, ranges, median scores etc).
This study is exploratory in nature, and the sample size will be determined iteratively based on the variance observed in the early stages of data collection. A more precise sample size will be refined as the analysis progresses to ensure adequate power and meaningful insights.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
17/03/2025
Date of last participant enrolment
Anticipated
Actual
24/03/2025
Date of last data collection
Anticipated
11/04/2025
Actual
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 318334 0
Hospital
Name [1] 318334 0
Canberra Health Services
Country [1] 318334 0
Australia
Primary sponsor type
Individual
Name
Helen Truong - Canberra Health Services
Address
Country
Australia
Secondary sponsor category [1] 320827 0
None
Name [1] 320827 0
Address [1] 320827 0
Country [1] 320827 0
Other collaborator category [1] 283403 0
Individual
Name [1] 283403 0
Martin Seng - Canberra Health Services
Address [1] 283403 0
Country [1] 283403 0
Australia
Other collaborator category [2] 283401 0
Individual
Name [2] 283401 0
Helen Gustafsson - Canberra Health Services
Address [2] 283401 0
Country [2] 283401 0
Australia
Other collaborator category [3] 283402 0
Individual
Name [3] 283402 0
Jonathan Lee - Canberra Health Services
Address [3] 283402 0
Country [3] 283402 0
Australia
Other collaborator category [4] 283404 0
Individual
Name [4] 283404 0
Farhan Syed - Canberra Health Services
Address [4] 283404 0
Country [4] 283404 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316970 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 316970 0
Ethics committee country [1] 316970 0
Australia
Date submitted for ethics approval [1] 316970 0
17/01/2025
Approval date [1] 316970 0
13/03/2025
Ethics approval number [1] 316970 0

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

Contacts
Principal investigator
Name 139606 0
Miss Helen Truong
Address 139606 0
Canberra Region Cancer Centre, Building 19, The Canberra Hospital - Bateson Road, Garran ACT 2605
Country 139606 0
Australia
Phone 139606 0
+61 02 51248444
Fax 139606 0
Email 139606 0
[email protected]
Contact person for public queries
Name 139607 0
Helen Truong
Address 139607 0
Canberra Region Cancer Centre, Building 19, The Canberra Hospital - Bateson Road, Garran ACT 2605
Country 139607 0
Australia
Phone 139607 0
+61 02 51248444
Fax 139607 0
Email 139607 0
[email protected]
Contact person for scientific queries
Name 139608 0
Helen Truong
Address 139608 0
Canberra Region Cancer Centre, Building 19, The Canberra Hospital - Bateson Road, Garran ACT 2605
Country 139608 0
Australia
Phone 139608 0
+61 02 51248444
Fax 139608 0
Email 139608 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.