Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000534987
Ethics application status
Approved
Date submitted
2/03/2020
Date registered
30/04/2020
Date last updated
30/04/2020
Date data sharing statement initially provided
30/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Functional magnetic resonance Imaging GUided Radiation therapy dose Escalation in Head and Neck Cancer (FIGURE-rad HNC)
Scientific title
Functional magnetic resonance Imaging GUided Radiation therapy dose Escalation in Head and Neck Cancer (FIGURE-rad HNC)
Secondary ID [1] 300687 0
nil known
Universal Trial Number (UTN)
U1111-1249-0704
Trial acronym
FIGURE-rad HNC
Linked study record
not applicable

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Cancer 316499 0
Condition category
Condition code
Cancer 314744 314744 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to assess the feasibility of diffusion weighted magnetic resonance imaging (DW-MRI) guided radiation therapy dose escalation in head and neck cancer (HNC). Participants will need to attend an MRI scan at the Sunshine Coast University Hospital within one week prior to their standard radiotherapy planning CT. This scan will be performed with the participant lying in the radiation therapy treatment position with a custom fit immobilisation mask in place and may take up to an hour to perform.

Based on the quantitative information from this scan, a high-risk volume within the tumour will be identified. A boost dose of 5-7Gy in one fraction will be delivered to this tumour subvolume defined by an area of low apparent diffusion coefficient (ADC) value, representative of increased cellular density. This is followed by a 3-5 day break then the standard fractionated radiation therapy schedule of 66-70Gy over 6-7 weeks is delivered. Each individual treatment takes approximately 15 minutes.

The study will be conducted by the Radiation Oncology department at the Sunshine Coast University Hospital in Birtinya, Queensland. The participant will be asked to complete quality of life questionnaires at 5 different timepoints before, during and after the treatment period. These questionnaires may take up to 5mins to complete each time. Patients will be monitored closely by the treating team for any acute or late treatment side effects.
Intervention code [1] 317014 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323091 0
1. Locoregional control - From date of start of treatment to date of first clinical and/or imaging evidence of local or regional recurrence
Timepoint [1] 323091 0
Assessed by clinical examination and imaging studies if indicated as part of clinical follow up post treatment (3 monthly for the first year and then 6 monthly up to 5 years post treatment)
Secondary outcome [1] 380760 0
2. Quality of life using Patient Reported Outcome Measure (PROM) questionnaire. The University of Washington HNSS RTOG questionnaire has been selected as the preferred PROM for this study as the literature supports its ability to measure minimally clinical important difference (MCID) in key proximal outcomes of oral pain, appetite, dysphagia, xerostomia, fatigue and hoarseness across time points.
Timepoint [1] 380760 0
Pre-treatment; 2 weeks post boost dose; Final week of treatment; 2 weeks post treatment; 3 months post treatment
Secondary outcome [2] 380761 0
3. Toxicity - using the Common Terminology for Adverse Events (CTCAE) v4.0
Timepoint [2] 380761 0
Acute toxicity - during treatment and within 3 months after treatment
Late toxicity - after 3 months post treatment, for 5 years

Eligibility
Key inclusion criteria
- Histologically confirmed primary squamous cell carcinoma of the head and neck region
- Not fit for, or declined surgical resection and/or chemotherapy, or unresectable disease
- Able to give informed consent to treatment by understanding the nature, significances and consequences of the study
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 the head and neck region
- Evidence of metastatic disease
- Contraindication to MRI such as significant claustrophobia, pacemaker/defibrillator or implanted metals
- ECOG performance status greater than 2 or KPS less than 60
- Life expectancy likely less than 12 months due to other significant comorbidities
- Simultaneous participation in another interventional trial that may interfere with the results of this trial

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
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
Safety/efficacy
Statistical methods / analysis
Statistical analyses will be performed by using software IBM SPSS version 24. The Kaplan Meier survival analysis will be performed for locoregional control. Toxicity rates and PROMs will be compared to those from literature review.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/08/2020
Actual
Date of last participant enrolment
Anticipated
3/08/2021
Actual
Date of last data collection
Anticipated
3/08/2026
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 16033 0
Sunshine Coast University Hospital - Birtinya
Recruitment postcode(s) [1] 29546 0
4575 - Birtinya

Funding & Sponsors
Funding source category [1] 305131 0
Hospital
Name [1] 305131 0
Sunshine Coast University Hospital
Country [1] 305131 0
Australia
Funding source category [2] 305168 0
University
Name [2] 305168 0
University of the Sunshine Coast
Country [2] 305168 0
Australia
Primary sponsor type
Individual
Name
Dr Myo Min
Address
Adem Crosby Centre
Sunshine Coast University Hospital
Birtinya, QLD 4575
Country
Australia
Secondary sponsor category [1] 305491 0
Individual
Name [1] 305491 0
Dr Daisy Atwell
Address [1] 305491 0
Adem Crosby Centre
Sunshine Coast University Hospital
Birtinya, QLD 4575
Country [1] 305491 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305501 0
The Prince Charles Hospital HREC
Ethics committee address [1] 305501 0
Ethics committee country [1] 305501 0
Australia
Date submitted for ethics approval [1] 305501 0
06/01/2020
Approval date [1] 305501 0
02/03/2020
Ethics approval number [1] 305501 0
HREC/2020/QPCH/58359
Ethics committee name [2] 305895 0
University of the Sunshine Coast HREC
Ethics committee address [2] 305895 0
Ethics committee country [2] 305895 0
Australia
Date submitted for ethics approval [2] 305895 0
22/04/2020
Approval date [2] 305895 0
24/04/2020
Ethics approval number [2] 305895 0
S201425

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

Contacts
Principal investigator
Name 100582 0
Dr Myo Min
Address 100582 0
Adem Crosby Centre
Sunshine Coast University Hospital
Birtinya QLD 4575
Country 100582 0
Australia
Phone 100582 0
+61 7 5202 1111
Fax 100582 0
Email 100582 0
myo.min@health.qld.gov.au
Contact person for public queries
Name 100583 0
Daisy Atwell
Address 100583 0
Adem Crosby Centre
Sunshine Coast University Hospital
Birtinya QLD 4575
Country 100583 0
Australia
Phone 100583 0
+61 7 5202 1111
Fax 100583 0
Email 100583 0
daisy.atwell@health.qld.gov.au
Contact person for scientific queries
Name 100584 0
Daisy Atwell
Address 100584 0
Adem Crosby Centre
Sunshine Coast University Hospital
Birtinya QLD 4575
Country 100584 0
Australia
Phone 100584 0
+61 7 5202 1111
Fax 100584 0
Email 100584 0
daisy.atwell@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
For confidentiality reasons


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7194Informed consent form    From the Study Investigators



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.