Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001548820p
Ethics application status
Not yet submitted
Date submitted
22/09/2021
Date registered
15/11/2021
Date last updated
20/10/2022
Date data sharing statement initially provided
15/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A study investigating the feasibility of stereotactic radiotherapy for the palliation of Head and Neck Cancer
Scientific title
A Phase 2 study investigating the feasibility of stereotactic ablative body radiotherapy for the palliation of Head and Neck Cancer
Secondary ID [1] 305387 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
STEREOPHONIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Cancer 323741 0
Condition category
Condition code
Cancer 321270 321270 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will receive multi-fraction Stereotactic Ablative Body Radiation (SABR) 40Gy - 45Gy delivered in 5 fractions over two weeks with a minimum of 48 hours between each fraction. The treatment will be delivered by qualified radiation therapists.
Eligible participants will be prescribed according to the following groups:
-45Gy in 5 fractions (de novo radiation)
-40Gy in 5 fractions (for re-radiation or metastatic cancer)
Participants will be provided with their treatment schedule in advance and treatment administration details including duration, staff present, dose delivered etc will be recorded and verified in the electronic patient information system as per standard quality processes.
Intervention code [1] 321794 0
Treatment: Devices
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329048 0
Proportion of patients completing the SABR treatment without major protocol violations during treatment delivery and patient compliance assessed by audit of study database on a monthly basis and fortnightly MDT peer review of patients receiving SABR treatment. This is a composite primary outcome.
Timepoint [1] 329048 0
End of treatment for 40 recruited patients
Secondary outcome [1] 401269 0
Safety outcomes defined as number of participants experiencing minimal toxicities measured by CTCAE v5
Timepoint [1] 401269 0
Baseline (Pre-treatment), weekly during treatment, 4-6 weeks post treatment and every three months post treatment up to 24 months post treatment.
Secondary outcome [2] 401270 0
local progression free survival assessed by CT, MRI or PET scan (RECIST 1.1 scoring) and clinical assessment
Timepoint [2] 401270 0
3 monthly for up to 24 months post treatment
Secondary outcome [3] 401271 0
Overall survival assessed by clinical assessment
Timepoint [3] 401271 0
24 months post treatment
Secondary outcome [4] 401272 0
Time to distant failure assessed by CT, MRI or PET imaging and clinical assessment
Timepoint [4] 401272 0
3 monthly for up to 24 months post treatment
Secondary outcome [5] 401273 0
Quality of life outcomes as measured by FACT-H&N questionnaires
Timepoint [5] 401273 0
Baseline (Pre-treatment), weekly during treatment, 4-6 weeks post treatment and every three months post treatment up to 24 months post treatment.

Eligibility
Key inclusion criteria
All participants:
1. Age greater than or equal to 18 years
2. Clinical stage T0-T4, N0-N3, M0 or M1
3. Measurable tumour present in the head and neck region on PET
4. Between 1 and 3 separate high dose PTVs in the head and neck, measuring up to 6 cm each
5. Assessed by a head and neck multidisciplinary team, and deemed unsuitable for curative-intent surgery and / or radiotherapy due to poor performance status, comorbidities, or patient preference
6. ECOG 0-2
7. Life expectancy of at least 6 months
8. Provision of signed and dated informed consent form
9. Stated willingness to comply with all study procedures and availability for the duration of the study
Group 1 (de novo radiation) participants:
1. New diagnosis, recurrent, or second primary head and neck cancer with no prior radiotherapy to the region of current active disease
2. Histology or cytology confirming a diagnosis of squamous cell carcinoma (including both mucosal and cutaneous primaries, and all subtypes of nasopharyngeal carcinoma) of the head and neck.
Group 2 (reirradiation) participants:
1. Recurrent or second primary head and neck cancer with prior radiotherapy to the region of current active disease
2. Histology or cytology confirming a diagnosis of squamous cell carcinoma (including both mucosal and cutaneous primaries, and all subtypes of nasopharyngeal carcinoma) of the head and neck. Where a biopsy for recurrence is not feasible, the histology or cytology at initial diagnosis is sufficient.At least 6 months between prior radiotherapy and SABR
Group 3 (metastatic, non-head and neck primary) participants:
1. Metastatic cancer to the head and neck region from a non-head and neck primary tumour (regardless of radiotherapy naive or reirradiation)
2. All known sites of active cancer in the body can be treated with locally ablative or extirpative therapy (e.g. surgery, radiofrequency ablation, SABR, radical radiotherapy)
3. Up to 5 sites of active cancer in the body (i.e. oligometastatic or oligoprogressive disease)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. The patient would be better treated with an alternate fractionation schedule according to the treating clinician’s judgement
2. Tumours of the larynx / hypopharynx in the absence of prior laryngectomy
3. Use of cytotoxic chemotherapy or immunotherapy within 3 weeks prior to SABR
4. Histologies other than squamous cell carcinoma
5. Pregnancy
6. Concurrent illness, including severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
7. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol

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
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 20573 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 35357 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 309968 0
Government body
Name [1] 309968 0
South Western Sydney Local Health District
Country [1] 309968 0
Australia
Primary sponsor type
Government body
Name
South Western Sydney Local Health District
Address
Cnr of Goulburn and Elizabeth Streets, Liverpool Hospital, Liverpool, NSW 2170
Country
Australia
Secondary sponsor category [1] 310774 0
None
Name [1] 310774 0
Address [1] 310774 0
Country [1] 310774 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 309508 0
South Western Sydney Local Health District
Ethics committee address [1] 309508 0
Research and Ethics Office
Locked Bag 7103
Liverpool BC
NSW 1871
Ethics committee country [1] 309508 0
Australia
Date submitted for ethics approval [1] 309508 0
28/03/2023
Approval date [1] 309508 0
Ethics approval number [1] 309508 0

Summary
Brief summary
The main purpose of this study is to investigate the feasibility of Stereotactic Ablative Body Radiation (SABR), a method of delivering palliative radiotherapy, for patients with head and neck cancers.

Who is it for?
You may be eligible for this study if you are an adult aged 18 or older, you have been diagnosed with either primary head and neck cancer, or another cancer that has metastasized to your head and neck, and you have been assessed as unsuitable for curative-intent surgery and/or radiotherapy by the Head and Neck multidisciplinary team.

Study details
Participants who choose to enrol in this study will undergo a series of 5 radiotherapy treatment sessions over two weeks, with a minimum of 48 hours between each session. After the treatment sessions your radiation oncologist and the study team will follow up at 3 monthly intervals intervals to examine any side effects, the overall effectiveness and your quality of life. All participants will be assessed at regular intervals post treatment for up to two years.

It is hoped this research will provide more knowledge and understanding of the use of SABR in head and neck cancers in Australia. This information may then be used to improve health outcomes for future patients with head and neck cancers
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114402 0
Dr Joe Chang
Address 114402 0
Liverpool Cancer Therapy Centre,
Locked Bag 7103
Liverpool BC
1871 NSW
Country 114402 0
Australia
Phone 114402 0
+61 2 8738 9806
Fax 114402 0
+61 2 8738 9811
Email 114402 0
[email protected]
Contact person for public queries
Name 114403 0
Penny Phan
Address 114403 0
Liverpool Cancer Therapy Centre,
Locked Bag 7103
Liverpool BC
1871 NSW
Country 114403 0
Australia
Phone 114403 0
+61 2 8738 9148
Fax 114403 0
+61 2 8738 9205
Email 114403 0
[email protected]
Contact person for scientific queries
Name 114404 0
Penny Phan
Address 114404 0
Liverpool Cancer Therapy Centre,
Locked Bag 7103
Liverpool BC
1871 NSW
Country 114404 0
Australia
Phone 114404 0
+61 2 8738 9148
Fax 114404 0
+61 2 8738 9205
Email 114404 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data may be available upon request
When will data be available (start and end dates)?
Deidentified IPD will be available upon request during the duration of the study until archival.
Available to whom?
Data may be available to authorised study members. Any external members who wishes to access data will be required to provide sound proposal and assessed case-by-case by the Principal Investigator.
Available for what types of analyses?
Data may be available for further research or analyses to assess the aims of the study.
How or where can data be obtained?
Access to data will require approval by the Principal Investigator via contacting the Trial coordinating team email [email protected].


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13320Informed consent form  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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