Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001431516
Ethics application status
Approved
Date submitted
19/11/2024
Date registered
6/12/2024
Date last updated
6/12/2024
Date data sharing statement initially provided
6/12/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Stereotactic Ablative Radiotherapy (SABR) One Stop Service for Lung Cancer: A pilot study for early-stage Non-small cell lung cancer (NSCLC).
Scientific title
Stereotactic Ablative Radiotherapy (SABR) One Stop Service for Lung Cancer: A pilot study for early-stage Non-small cell lung cancer (NSCLC).
Secondary ID [1] 313424 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early-stage non-small cell lung cancer 335798 0
Condition category
Condition code
Cancer 332375 332375 0 0
Lung - Non small cell
Public Health 332496 332496 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients over the age of 18 with early-stage non-small-cell lung cancer (NSCLC), referred for SABR (either histologically confirmed lung cancer and/or MDM recommendation), will undergo, consent CT simulation, contouring, planning and treatment all in one single visit. Once consented, treatment will happen within the same visit, customised to one of two options based on travel requirements:
(1) If most convenient to attend for a morning planning CT scan (30-60mins), treatment will be delivered in the afternoon. There will be a gap of roughly 4-6 hours between scan and treatment. Patients are free to leave the hospital during this time. Total time in the hospital may be anywhere from approximately 2-8 hours on that day.
(2) If most convenient to attend for an afternoon planning CT scan, treatment will be delivered the next morning. CT simulation scan would take approximately 30-60mins, after which you are free to go home and then will be required to return the next morning for treatment. Total time across both days at the hospital can be approximately 2-8 hours.
Patients will then be asked to complete a survey about their experience and have one telehealth follow-up consultation (20 mins) 2 weeks post SABR one-stop visit as part of routine clinical practice.
Intervention code [1] 329990 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339929 0
Proportion of patients who complete simulation, planning, and treatment within 8 hours, assessed as a composite primary outcome.
Timepoint [1] 339929 0
Recruitment to end of participation
Secondary outcome [1] 441951 0
Patient satisfaction
Timepoint [1] 441951 0
Post single visit

Eligibility
Key inclusion criteria
Adult Patients (min 18 years old)
Referred for SABR for either: Histologically-confirmed lung cancer and/or MDM Recommendation for empiric SABR based on clinical and radiological features which are deemed to represent lung cancer
Staging is T1-T2 N0M0 based on CT and/or PET/CT imaging o Diagnostic imaging performed within 6 weeks of study enrolment
Non-central tumour location (i.e. Gross Tumour Volume (GTV) at least 2cm from proximal bronchial tree)
Provides informed consent
Fit to attend for the length of time required, whether fully independent, or by spending some or all of this time with nursing care in the radiotherapy trolley bay.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to complete patient experience survey based on cognitive impairment or other comorbidities

Lack of suitable diagnostic images which is an important screening tool as part of the preplanning stage

Unable to meet Peter MacCallum Cancer Centre clinical goals for SF SABR based on virtual pre-planning

Previous radiotherapy which may overlap with the current lesion planned for treatment

Synchronous malignancy also planned for oncological treatment

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
12/06/2024
Date of last participant enrolment
Anticipated
25/11/2025
Actual
Date of last data collection
Anticipated
9/12/2025
Actual
Sample size
Target
10
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27345 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 43436 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 317857 0
Charities/Societies/Foundations
Name [1] 317857 0
Peter MacCallum Cancer Foundation
Country [1] 317857 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
Country
Australia
Secondary sponsor category [1] 320189 0
None
Name [1] 320189 0
Address [1] 320189 0
Country [1] 320189 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316536 0
Peter MacCallum Cancer Centre Human Research Ethics Committee
Ethics committee address [1] 316536 0
Ethics committee country [1] 316536 0
Australia
Date submitted for ethics approval [1] 316536 0
03/01/2024
Approval date [1] 316536 0
08/02/2024
Ethics approval number [1] 316536 0

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

Contacts
Principal investigator
Name 138198 0
A/Prof Susan Harden
Address 138198 0
Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne Victoria 3000
Country 138198 0
Australia
Phone 138198 0
+61 3 85597943
Fax 138198 0
Email 138198 0
susan.harden@petermac.org
Contact person for public queries
Name 138199 0
Susan Harden
Address 138199 0
Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne Victoria 3000
Country 138199 0
Australia
Phone 138199 0
+61 3 85597943
Fax 138199 0
Email 138199 0
susan.harden@petermac.org
Contact person for scientific queries
Name 138200 0
Susan Harden
Address 138200 0
Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne Victoria 3000
Country 138200 0
Australia
Phone 138200 0
+61 3 85597943
Fax 138200 0
Email 138200 0
susan.harden@petermac.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.