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Trial registered on ANZCTR
Registration number
ACTRN12622000495729
Ethics application status
Approved
Date submitted
11/03/2022
Date registered
28/03/2022
Date last updated
21/04/2024
Date data sharing statement initially provided
28/03/2022
Type of registration
Prospectively registered
Titles & IDs
Public title
Immune cell distribution change after radiation therapy in patients with advanced head and neck cancer
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Scientific title
Stereotactic Ablative Radiotherapy and T Cell Biodistribution for Oligoprogressive Head and Neck Cancer (START-HN)
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Secondary ID [1]
306609
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none
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Universal Trial Number (UTN)
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Trial acronym
START-HN
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Oligoprogressive head and neck cancer
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Condition category
Condition code
Cancer
322899
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0
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Head and neck
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Eligible study participants will be treated with stereotactic ablative radiotherapy (SBRT) at the department of Radiation Oncology. SBRT is the standard of care for patients with limited areas of progressive disease. The process of the radiotherapy includes simulation, radiation planning and delivery.
During the simulation, all patients will undergo CT and MR of the region of interest encompassing the disease to be treated. Patient’s positioning and immobilisation device will also be determined.
Based on planning CT and MRI, the gross tumour volume, the number of the oligo-progressive sites that can be treated and targetable with SBRT will be determined by one of the investigators (consultant radiation oncologists). Dose and fractions will be prescribed according to the tumour site, total radiation dose may span from 16 to 60 grays, the number of fractions can be between 1 and 8, and the dose for each treatment session (fraction) will be between 6 to 34 grays.
SBRT will be delivered by 2 qualified and experienced radiotherapists. One fraction will be delivered each day, the total dose will be given on consecutive weekdays or every 2nd day.
The PET scan will be done at Austin PET centre, the department is well equipped and is able to generate 89Zr labelled antibodies. The radiotracer will be administered via IV injection, and the scan will take 60 to 90 minutes.
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Intervention code [1]
323043
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Treatment: Other
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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The changes in CD8+ T cells biodistribution in the body and tumour after SBRT.
To detect whole body and tumour immune cells (CD8 T cell) distribution in patients with head and neck cancer, PET imaging study using an anti-CD8 radiolabelled minibody 89Zr-Df-IAB22M2C will be performed at baseline and 2-week post radiotherapy. Biodistribution changes post radiotherapy from baseline will be analysed.
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Assessment method [1]
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Timepoint [1]
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2 weeks after SBRT
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Secondary outcome [1]
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To assess the utility of anti-CD8+ PET imaging and to correlate imaging finds with circulating T cell profile
At the same time of PET imaging, the blood samples will be collected to assess the circulating immune cell (CD8 T cell) level. Correlation of whole body CD8 distribution by PET imaging with circulating CD8 T cell levels may confirm the effectiveness of anti-CD8+ PET imaging.
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Assessment method [1]
407165
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Timepoint [1]
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2 weeks after SBRT
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Eligibility
Key inclusion criteria
head and neck SCC with oligo-progression to 1-10 extracranial lesions, lesion size no more than 5cm and involving no more than 3 organs.
Sites of oligo-progressive disease can be targetable with SBRT and safely treated
At least one tumour lesion can be observed and will not be in the beam path of SBRT, and the observed lesion must be measurable by the criteria of RECIST version 1.1
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Metastatic or locoreginal disease disease invades the GI tract or large blood vessels
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
15/05/2024
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
10
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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The Austin Medical Research Foundation (AMRF)
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Address [1]
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145 - 163 Studley Road
Heidelberg Vic 3084
Australia
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Country [1]
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Australia
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Primary sponsor type
Other Collaborative groups
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Name
Olivia Newton-John Cancer Research Institute (ONJCRI)
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Address
145 Studley Road,
Heidelberg, VIC 3084
Australia
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
312246
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Country [1]
312246
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Austin Health Human Research Ethics Committee
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Ethics committee address [1]
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145 Studley Road
Heidelberg, VIC 3084
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
310499
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Approval date [1]
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09/09/2021
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Ethics approval number [1]
310499
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Summary
Brief summary
The purpose of this study is to compare the immune responses within cancer tumours which have and have not been treated with stereotactic ablative body radiotherapy (SBRT).
Who is it for?
You may be eligible to join this study if you are aged 18 years or older, and have cancer in the head or neck regions.
Study details
All patients undergo SBRT to tumour sites, which delivers a high dose of radiotherapy to the tumour. This will occur across 1-8 treatment sessions (fractions), and most likely 3-5 fractions for one tumour site, and one fraction will be given each day over 30 minutes. Depending on the tumour site, fractions can be given on consecutive weekdays or every 2nd weekday. Your treatment sessions will depend on the number of tumour sites that the doctor considers can be safely treated with SBRT. Before and after SBRT, there will be PET imaging using novel tracer 89Zr-Df-IAB22M2C to track immune cells in the tumour and in the whole body. Blood tests will also be performed before and after SBRT.
It is hoped that this research will provide information on how to best deliver immunotherapy with SBRT radiotherapy, thus improving treatment of head and neck cancer.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Sweet Ping Ng
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Address
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Department of Radiation Oncology
Austin Health
145 Studley Road,
Heidelberg, VIC 3084
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Country
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Australia
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Phone
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+61 3 9496 9183
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Ms Yuan Guo
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Address
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Department of Radiation Oncology
Austin Health
145 Studley Road
Heidelberg, VIC 3084
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Country
117883
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Australia
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Phone
117883
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+61 3 9496 9419
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Sweet Ping Ng
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Address
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Department of Radiation Oncology
Austin Health
145 Studley Road
Heidelberg, VIC 3084
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Country
117884
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Australia
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Phone
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+61 3 9496 2800
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Fax
117884
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Email
117884
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
this is a pilot study and no IPD is planned
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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.
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