Trial Review

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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
Scientific title
Stereotactic Ablative Radiotherapy and T Cell Biodistribution for Oligoprogressive Head and Neck Cancer (START-HN)
Secondary ID [1] 306609 0
none
Universal Trial Number (UTN)
Trial acronym
START-HN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oligoprogressive head and neck cancer 325531 0
Condition category
Condition code
Cancer 322899 322899 0 0
Head and neck

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 323043 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330675 0
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.
Timepoint [1] 330675 0
2 weeks after SBRT
Secondary outcome [1] 407165 0
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.
Timepoint [1] 407165 0
2 weeks after SBRT

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Metastatic or locoreginal disease disease invades the GI tract or large blood vessels

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/05/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 310945 0
Charities/Societies/Foundations
Name [1] 310945 0
The Austin Medical Research Foundation (AMRF)
Country [1] 310945 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Olivia Newton-John Cancer Research Institute (ONJCRI)
Address
145 Studley Road,
Heidelberg, VIC 3084
Australia
Country
Australia
Secondary sponsor category [1] 312246 0
None
Name [1] 312246 0
Address [1] 312246 0
Country [1] 312246 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310499 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 310499 0
145 Studley Road
Heidelberg, VIC 3084
Ethics committee country [1] 310499 0
Australia
Date submitted for ethics approval [1] 310499 0
Approval date [1] 310499 0
09/09/2021
Ethics approval number [1] 310499 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117882 0
Dr Sweet Ping Ng
Address 117882 0
Department of Radiation Oncology
Austin Health
145 Studley Road,
Heidelberg, VIC 3084
Country 117882 0
Australia
Phone 117882 0
+61 3 9496 9183
Fax 117882 0
Email 117882 0
sweetping.ng@austin.org.au
Contact person for public queries
Name 117883 0
Ms Yuan Guo
Address 117883 0
Department of Radiation Oncology
Austin Health
145 Studley Road
Heidelberg, VIC 3084
Country 117883 0
Australia
Phone 117883 0
+61 3 9496 9419
Fax 117883 0
Email 117883 0
yuan.guo@austin.org.au
Contact person for scientific queries
Name 117884 0
Dr Sweet Ping Ng
Address 117884 0
Department of Radiation Oncology
Austin Health
145 Studley Road
Heidelberg, VIC 3084
Country 117884 0
Australia
Phone 117884 0
+61 3 9496 2800
Fax 117884 0
Email 117884 0
sweetping.ng@austin.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
this is a pilot study and no IPD is planned


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.