Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000522516p
Ethics application status
Not yet submitted
Date submitted
21/02/2024
Date registered
26/04/2024
Date last updated
26/04/2024
Date data sharing statement initially provided
26/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Partially Ablative Body Radiotherapy (PABR) for the Palliation of Bulky Tumours
Scientific title
A Prospective Single-Arm Pilot Study of the Safety, Tolerability and Preliminary Efficacy of Partially Ablative Body Radiotherapy (PABR) for the Palliation of Bulky Tumours
Secondary ID [1] 311581 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
locally advanced tumours 332962 0
bulky tumours 333156 0
unresectable tumours 333157 0
Condition category
Condition code
Cancer 329675 329675 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The treatment for this study is partially ablative body radiotherapy (PABR). This technique delivers an ablative dose to the central core of the tumour and a palliative dose to the periphery using simultaneous integrated boost (SIB). Prescribed dose for all patients is 20Gray in 5 fractions with SIB to 50Gy, delivered on non-consecutive days over 2 weeks, at 2-3 visits per week. Each treatment visit may take up to 30 minutes. Treatment will be prescribed by a Radiation Oncologist and delivered at a radiotherapy centre approved as a study site.
Prior to treatment commencing, all participants will be required to attend for a planning CT scan. Participants will be positioned using stabilisation and/or immobilisation equipment to ensure that set-up can be reproduced on each day of treatment. This planning appointment may take 1 hour.
To ensure treatment is delivered as planned, a daily online image guidance procedure will be performed. Additionally, the direct observation of PABR administration by the Investigator and site staff will ensure compliance with the protocol requirements. The date and time of each dose and fraction of PABR administered in the clinic will be recorded in the participant’s medical record and study electronic case report form.
Intervention code [1] 328034 0
Treatment: Other
Comparator / control treatment
no control group - this is a single-arm study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337458 0
Incidence of acute and late toxicities including at least grade 3 treatment related adverse events
Timepoint [1] 337458 0
Adverse events will be assessed at every treatment visit, then at weeks 4, 8 and 12 from the start of PABR, then months 6, 9, and 12 from the start of PABR
Primary outcome [2] 337941 0
Changes in laboratory parameters from baseline.
Timepoint [2] 337941 0
Laboratory parameters will be assessed at baseline, at the first and last treatment visits, then at weeks 8 and 12 from the start of PABR and then at month 6, 9 and 12 from the start of PABR.
Primary outcome [3] 338020 0
Changes in Eastern Cooperative Oncology Group (ECOG) performance status from baseline.
Timepoint [3] 338020 0
ECOG will be assessed at baseline, at the first and last treatment visits, then at weeks 8 and 12 from the start of PABR and then at month 6, 9 and 12 from the start of PABR.
Secondary outcome [1] 431950 0
Tumour absolute volume difference
Timepoint [1] 431950 0
Tumour assessment imaging conducted at baseline, at 12 weeks after the start of PABR, then 3-monthly until 12 months from the start of PABR treatment.
Secondary outcome [2] 431951 0
Objective response rate, defined as the proportion of patients with either complete or partial response
Timepoint [2] 431951 0
Tumour assessment imaging conducted at baseline, at 12 weeks after the start of PABR, then 3-monthly until 12 months from the start of PABR treatment.
Secondary outcome [3] 433812 0
Local tumour control, defined as the proportion of patients with either complete/partial response or stable disease
Timepoint [3] 433812 0
Tumour assessment imaging conducted at baseline, at 12 weeks after the start of PABR, then 3-monthly until 12 months from the start of PABR treatment.
Secondary outcome [4] 433813 0
One-year progression free survival, defined as the time from the start of treatment to the onset of tumour progression or death from any cause and one-year overall survival defined as the time from the start of treatment to the date of death from any cause
Timepoint [4] 433813 0
Tumour assessment imaging conducted at baseline, at 12 weeks after the start of PABR, then 3-monthly until 12 months from the start of PABR treatment.
Secondary outcome [5] 433814 0
Abscopal tumour response, defined as a reduction of at least 30% in diameter of the best responding non-irradiated lesion before initiation of the next line of systemic therapy
Timepoint [5] 433814 0
Tumour assessment imaging conducted at baseline, at 12 weeks after the start of PABR, then 3-monthly until 12 months from the start of PABR treatment
Secondary outcome [6] 433815 0
Patient-reported change in pain symptoms
Timepoint [6] 433815 0
Patient reported outcomes assessed at days 1, 3 and 5 of PABR, at weeks 4, 8 and 12 from start of treatment, then months 6, 9 and 12 from the start of PABR
Secondary outcome [7] 433816 0
Difference in opioid dose
Timepoint [7] 433816 0
Assessed at days 1, 3 and 5 of PABR, at weeks 4, 8 and 12 from start of treatment, then months 6, 9 and 12 from the start of PABR
Secondary outcome [8] 433817 0
Change in quality of life
Timepoint [8] 433817 0
Assessed at days 1, 3 and 5 of PABR, at weeks 4, 8 and 12 from start of treatment, then months 6, 9 and 12 from the start of PABR.
Secondary outcome [9] 434160 0
Patient-reported change in neuropathic symptoms and signs
Timepoint [9] 434160 0
Patient reported outcomes assessed at days 1 and 3 of PABR, and 4 weeks from the start of PABR
Secondary outcome [10] 434161 0
Patient reported change in cancer-related symptom burden (for example: pain, fatigue, drowsiness, nausea, lack of appetite, shortness of breath, depression, anxiety, wellbeing, etc)
Timepoint [10] 434161 0
Patient reported outcomes assessed at days 1, 3 and 5 of PABR, at weeks 4, 8 and 12 from start of treatment, then months 6, 9 and 12 from the start of PABR

Eligibility
Key inclusion criteria
Histologically or cytologically confirmed non-haematologic malignancy not amenable to curative intent treatment.
Must be a candidate for palliative radiotherapy for a tumour size of at least 5cm as measured by clinical examination or radiologic imaging
At least one measurable disease tumour lesion as assessed by investigator per RECIST v1.1
Not suitable for SABR (stereotactic ablative body radiotherapy) or surgery, or has declined surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Tumours at or within 2cm from spinal cord
Prior radiotherapy that overlaps with planned site of intervention within 2 years prior to screening
Received concurrent cytotoxic or targeted therapy within 3-4 weeks prior to the fraction of PABR, or concurrent use of these therapies during intervention period
Evidence of central necrosis on imaging

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
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
1/07/2025
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26195 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 42071 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 315883 0
Charities/Societies/Foundations
Name [1] 315883 0
Peter MacCallum Cancer Foundation
Country [1] 315883 0
Australia
Funding source category [2] 315885 0
Government body
Name [2] 315885 0
Victorian Cancer Agency
Country [2] 315885 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
Country
Australia
Secondary sponsor category [1] 318026 0
None
Name [1] 318026 0
Address [1] 318026 0
Country [1] 318026 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 314729 0
Peter MacCallum Cancer Centre Human Research Ethics Committee
Ethics committee address [1] 314729 0
https://www.petermac.org/research/doing-research-us/ethics-governance
Ethics committee country [1] 314729 0
Australia
Date submitted for ethics approval [1] 314729 0
27/05/2024
Approval date [1] 314729 0
Ethics approval number [1] 314729 0

Summary
Brief summary
This study is assessing the safety and efficacy of a new way of delivering radiotherapy, called Partially Ablative Body Radiotherapy (PABR), to tumours that are considered too bulky to treat with curative intent.

Who is it for?
You may be eligible for this study if you have a confirmed diagnosis of a non-haematologic malignancy not amenable to curative intent treatment, however are a candidate for palliative radiotherapy for a tumour size of at least 5cm.

Study details
Patients will undergo 5 sessions of radiotherapy on non-consecutive days over 2 weeks. The radiotherapy will be planned to deliver a higher dose to the core of the tumour and a lower, palliative dose to the periphery. Participants will have data collected on treatment related adverse events and tumour response to the radiotherapy, and will be asked to complete questionnaires on outcomes such as pain and quality of life.

It is hoped that findings from this study will help develop PABR as a treatment modality for the palliation of bulky tumours.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132546 0
Dr Sarat Chander
Address 132546 0
Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne VIC 3000
Country 132546 0
Australia
Phone 132546 0
+61 3 85597742
Fax 132546 0
Email 132546 0
Sarat.Chander@petermac.org
Contact person for public queries
Name 132547 0
Catherine Anderson
Address 132547 0
Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne VIC 3000
Country 132547 0
Australia
Phone 132547 0
+61 3 85595000
Fax 132547 0
Email 132547 0
RadOnc.Research@petermac.org
Contact person for scientific queries
Name 132548 0
Sarat Chander
Address 132548 0
Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne VIC 3000
Country 132548 0
Australia
Phone 132548 0
+61 3 85595000
Fax 132548 0
Email 132548 0
Sarat.Chander@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.