Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000311459
Ethics application status
Approved
Date submitted
2/04/2025
Date registered
16/04/2025
Date last updated
16/04/2025
Date data sharing statement initially provided
16/04/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Functional Imaging Guided Salivary Gland Sparing Radiation Therapy
Scientific title
Effect of Functional Imaging Guided Salivary Gland Sparing Radiation Therapy on Xerostomia Toxicity and Quality of Life in Adults with Primary Carcinoma of the Head and Neck Region.
Secondary ID [1] 314115 0
Nil known
Universal Trial Number (UTN)
Trial acronym
FIGS-RT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Xerostomia 336069 0
Reduced quality of life 337018 0
Head and Neck Cancer 336068 0
Condition category
Condition code
Cancer 332619 332619 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A biological at-risk volume (BRV) within the parotid gland will be generated using the apparent diffusion coefficient map from the diffusion weighted magnetic resonance imaging (MRI) scan. This volume will be avoided during radiotherapy dose optimisation for head and neck cancer. This intervention will be completed across multiple disciplines, The radiation oncologist and radiation therapist will generate the BRV during the radiotherapy planning stages, the radiation therapist will complete the dose optimisation, the radiation oncologist will approve the plan, medical physicist will perform patient specific quality assurance and the radiation therapists will administer the treatment. Daily cone beam computed tomography imaging will be performed prior to treatment where an evaluation will be made on any patient separation changes, however the primary tumour will be prioritised during imaging. Common Terminology Criteria for Adverse Events and patient quality of life questionnaires will be completed at specific time points to monitor outcomes.
Intervention code [1] 330152 0
Treatment: Other
Comparator / control treatment
Data from the 2011 phase 3 multicentre randomised controlled trial: parotid-sparing intensity modulated versus conventional radiotherapy in head and neck cancer (PARSPORT). Recruitment was between Jan 21, 2003, and Dec 7, 2007.

Nutting CM, Morden JP, Harrington KJ, Urbano TG, Bhide SA, Clark C, Miles EA, Miah AB, Newbold K, Tanay M, Adab F, Jefferies SJ, Scrase C, Yap BK, A'Hern RP, Sydenham MA, Emson M, Hall E; PARSPORT trial management group. Parotid-sparing intensity modulated versus conventional radiotherapy in head and neck cancer (PARSPORT): a phase 3 multicentre randomised controlled trial. Lancet Oncol. 2011 Feb;12(2):127-36. doi: 10.1016/S1470-2045(10)70290-4. Epub 2011 Jan 12. PMID: 21236730; PMCID: PMC3033533.
Control group
Historical

Outcomes
Primary outcome [1] 340953 0
Change in xerostomia toxicity
Timepoint [1] 340953 0
Baseline (before treatment starts), Weekly from week 2 during treatment. Follow up - 1, 3, 6, 9, 12, 18, 24, 36, 48, 60 months after the completion of radiation therapy treatment
Secondary outcome [1] 445599 0
Change in patient Quality of Life for Head and Neck Cancer Patients
Timepoint [1] 445599 0
Baseline (before radiation therapy treatment starts), Week 3 of radiation treatment and final week of radiation treatment. Then 4 weeks, 3, 12, 18 and 24 months after the completion of radiation therapy.

Eligibility
Key inclusion criteria
- Histologically confirmed primary carcinoma of the head and neck region with an intention to spare one or more major salivary glands
- Suitable for magnetic resonance imaging (MRI) Simulation
- Aged 18 years or older
- Have the ability to provide informed consent
- Undergoing radical or high dose palliative intent primary radiation therapy +/- chemotherapy to a minimum prescription of 50Gy in 20 fractions (number of treatments)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Previous radiation therapy to major salivary glands
- Pre-existing loss of salivary function eg. Previous salivary condition
- Pregnancy
- Recruitment to another clinical trial
- Contraindication to MRI (Significant claustrophobia, pacemaker/defibrillator or other active implanted devices or implanted metals or foreign bodies)

Study design
Purpose of the study
Prevention
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
Efficacy
Statistical methods / analysis
Due to the expected sample size for this pilot study we are unable to recruit and adequately powered sample size to calculate the statistical power and determine an effect size.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
1/01/2024
Date of last participant enrolment
Anticipated
Actual
20/12/2024
Date of last data collection
Anticipated
1/03/2030
Actual
Sample size
Target
30
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 27691 0
Sunshine Coast University Hospital - Birtinya
Recruitment postcode(s) [1] 43880 0
4575 - Birtinya

Funding & Sponsors
Funding source category [1] 318023 0
Government body
Name [1] 318023 0
Sunshine Coast Hospital Health Service
Country [1] 318023 0
Australia
Primary sponsor type
Hospital
Name
Sunshine Coast University Hospital
Address
Country
Australia
Secondary sponsor category [1] 321036 0
None
Name [1] 321036 0
Address [1] 321036 0
Country [1] 321036 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316681 0
Metro North Health Human Research Ethics Committee A
Ethics committee address [1] 316681 0
Ethics committee country [1] 316681 0
Australia
Date submitted for ethics approval [1] 316681 0
12/11/2019
Approval date [1] 316681 0
16/12/2019
Ethics approval number [1] 316681 0
HREC/2019/QPCH/57691

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138646 0
Ms Katelyn Cahill
Address 138646 0
Sunshine Coast University Hospital, Adem Crosby Centre Radiation Oncology - 6 Doherty St, Birtinya QLD 4575
Country 138646 0
Australia
Phone 138646 0
+61 7 52020708
Fax 138646 0
Email 138646 0
[email protected]
Contact person for public queries
Name 138647 0
Katelyn Cahill
Address 138647 0
Sunshine Coast University Hospital, Adem Crosby Centre Radiation Oncology - 6 Doherty St, Birtinya QLD 4575
Country 138647 0
Australia
Phone 138647 0
+61 7 52020708
Fax 138647 0
Email 138647 0
[email protected]
Contact person for scientific queries
Name 138648 0
Katelyn Cahill
Address 138648 0
Sunshine Coast University Hospital, Adem Crosby Centre Radiation Oncology - 6 Doherty St, Birtinya QLD 4575
Country 138648 0
Australia
Phone 138648 0
+61 7 52020708
Fax 138648 0
Email 138648 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: This is not approved as part of the data collection in the ethics application



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.