ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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]

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

Condition category

Condition code

Cancer

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]

Treatment: Devices

Comparator / control treatment

No Control Group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

End of treatment for 40 recruited patients

Secondary outcome [1]

Safety outcomes defined as number of participants experiencing minimal toxicities measured by CTCAE v5

Timepoint [1]

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]

local progression free survival assessed by CT, MRI or PET scan (RECIST 1.1 scoring) and clinical assessment

Timepoint [2]

3 monthly for up to 24 months post treatment

Secondary outcome [3]

Overall survival assessed by clinical assessment

Timepoint [3]

24 months post treatment

Secondary outcome [4]

Time to distant failure assessed by CT, MRI or PET imaging and clinical assessment

Timepoint [4]

3 monthly for up to 24 months post treatment

Secondary outcome [5]

Quality of life outcomes as measured by FACT-H&N questionnaires

Timepoint [5]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Liverpool Hospital - Liverpool

Recruitment postcode(s) [1]

2170 - Liverpool

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

South Western Sydney Local Health District

Address [1]

Cnr of Goulburn and Elizabeth Streets, Liverpool Hospital, Liverpool, NSW 2170

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

South Western Sydney Local Health District

Ethics committee address [1]

Research and Ethics Office
Locked Bag 7103
Liverpool BC
NSW 1871

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/03/2023

Approval date [1]

Ethics approval number [1]

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

Dr Joe Chang

Address

Liverpool Cancer Therapy Centre,
Locked Bag 7103
Liverpool BC
1871 NSW

Country

Australia

Phone

+61 2 8738 9806

Fax

+61 2 8738 9811

joe.chang@health.nsw.gov.au

Contact person for public queries

Name

Penny Phan

Address

Liverpool Cancer Therapy Centre,
Locked Bag 7103
Liverpool BC
1871 NSW

Country

Australia

Phone

+61 2 8738 9148

Fax

+61 2 8738 9205

penny.phan@health.nsw.gov.au

Contact person for scientific queries

Name

Penny Phan

Address

Liverpool Cancer Therapy Centre,
Locked Bag 7103
Liverpool BC
1871 NSW

Country

Australia

Phone

+61 2 8738 9148

Fax

+61 2 8738 9205

penny.phan@health.nsw.gov.au

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 SWSLHD-RadOncClinicalTrials@health.nsw.gov.au.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
13320	Informed consent form			SWSLHD-RadOncClinicalTrials@health.nsw.gov.au

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.

Trial Review

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