Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000771550
Ethics application status
Approved
Date submitted
14/07/2015
Date registered
24/07/2015
Date last updated
24/07/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Adaptive Radiotherapy for Head and Neck Cancer: Feasibility and Clinical Implications
Scientific title
Effect of Adaptive Radiotherapy on the dose to Organs at Risk and Target Volumes in patients with Locally Advanced Head and Neck Cancer
Secondary ID [1] 287030 0
Nil
Universal Trial Number (UTN)
Trial acronym
ART Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Cancer 295496 0
Condition category
Condition code
Cancer 295753 295753 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Adaptive radiotherapy involves re-planning the radiation treatment during the course of treatment to account for changes in shape due to tumour shrinkage and patient weight loss. This can potentially reduce the radiation dose received by normal structures (particularly the parotid salivary glands), and increase the dose received by the target volume.

Patients will undergo standard curative-intent definitive radiotherapy (70Gy in 35 fractions, 2Gy per fraction, 1 fraction per day delivered 5 days per week for overall duration of 7 weeks). The participants will continue with this dose schedule for the whole course of treatment. At 3 and 5 weeks of treatment they will undergo both a repeat radiotherapy planning CT and repeat PET-CT. The repeat planning CT will be loaded on to the radiotherapy treatment planning system. The patient's initial RT plan will be overlaid on to this and re-calculated by the treatment planning system to give the new expected dose distribution on the patient's altered anatomy. The PI will then manually re-contour all the target volumes and normal structures on the repeat scans to create a new RT plan. We will then compare the dose distribution between the original plan and the re-contoured plan. to determine whether adaptive re-planning can reduce the dose to organs at risk or improve the dose to the target volume.

The participants will continue with treatment using their original radiotherapy plan unless the treating radiation oncologist deems it necessary to alter the treatment volumes (current standard treatment).

We will also assess whether the added workload associated with adaptive replanning is feasible in our department.
Intervention code [1] 292238 0
Treatment: Other
Comparator / control treatment
There is no control arm in this study but patients will act as their own control. The standard radiotherapy plan (control) will be compared to the adaptive plan (intervention) in each patient.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295467 0
Dose to organs at risk (salivary glands, mandible, spinal cord) as predicted using the radiotherapy treatment planning system and dose accumulation method for the adaptive plans.
Timepoint [1] 295467 0
On completion of radiotherapy treatment, approximately 7 weeks.
Primary outcome [2] 295614 0
Dose to Planning Target Volume as predicted using the radiotherapy treatment planning system and dose accumulation method for the adaptive plans.

The maximum dose, minimum dose, mean dose, D98% (dose to 98% of the volume), D2% (dose to 2% of the volume) and a dose-volume histogram are automatically calculated and recorded by the radiotherapy treatment planning system from the radiotherapy planning CT.
Timepoint [2] 295614 0
On completion of radiotherapy treatment, approximately 7 weeks.
Secondary outcome [1] 315643 0
Time (hours) taken for all re-planning.
The time taken for re-contouring will be recorded for each participant by the PI performing the contouring, and an estimate of the time taken for the radiation therapists to re-plan the treatment will be added to this for each re-plan.
Timepoint [1] 315643 0
On completion of radiotherapy treatment (approximately 7 weeks)

Eligibility
Key inclusion criteria
- Age 18 years or above
- Histologically proven squamous cell carcinoma of the head and neck region (oropharynx, nasopharynx, hypopharynx, larynx)
- Locally advanced disease (AJCC Stage III/IV)
- Multidisciplinary decision to treat with curative intent definitive radiation or chemoradiation using Image-guided IMRT/VMAT
- ECOG 0-2
- Able to give informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Definitive surgery to primary tumour or nodal disease
- Neoadjuvant chemotherapy
- Prior radiotherapy or chemotherapy
- Previous malignancy (except treated cutaneous skin cancers)
- Pregnant or breastfeeding women
- Both parotid glands entirely within the target volume (unable to achieve parotid sparing)
- Contraindications to radiotherapy (e.g. radiosensitivity syndromes)

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/08/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 3995 0
Fiona Stanley Hospital - Murdoch

Funding & Sponsors
Funding source category [1] 291580 0
Government body
Name [1] 291580 0
WA Cancer and Palliative Care Network Cancer Fellowship
Country [1] 291580 0
Australia
Primary sponsor type
Individual
Name
Susan Mincham
Address
Radiation Oncology
Fiona Stanley Hospital
102-118 Murdoch Drive
Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 290252 0
None
Name [1] 290252 0
Address [1] 290252 0
Country [1] 290252 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293115 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 293115 0
Office 212, Level 2, Southern Research Facility
Fiona Stanley Hospital
102-118 Murdoch Drive
Murdoch WA 6150
Ethics committee country [1] 293115 0
Australia
Date submitted for ethics approval [1] 293115 0
05/05/2015
Approval date [1] 293115 0
25/06/2015
Ethics approval number [1] 293115 0
15/33

Summary
Brief summary
This project aims to evaluate whether a protocol of adaptive radiotherapy (ART) for Head and Neck cancer patients can provide significant reduction in radiotherapy dose to critical structures, particularly the parotid salivary glands, aiming to potentially reduce the long term side effects of radiotherapy (particularly dry mouth).

Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with locally advanced head and neck cancer for which you plan to undergo curative-intent definitive radiotherapy.

Study details
All participants in this study will receive standard radiotherapy treatment (5 days a week for 7 weeks) as prescribed by the treating Radiation Oncologist. At 3 weeks and 5 weeks participants will have a repeat non-contrast planning CT scan plus repeat PET scan. We then overlay the initial radiotherapy plan on to the new CT dataset to determine if there are significant shape changes, whether the critical structures are receiving too much dose, or if the target volume (the tumour) is receiving too little dose. The participant’s radiotherapy plan will only be altered if there are unacceptable areas of radiotherapy over or under-dosage according to the discretion of the treating radiation oncologist.
All participants will have a new radiotherapy plan created using their repeat scans. These plans will be run through our treatment planning computers to model the dose distribution on the new CT datasets. We will then compare the dose received by the normal structures and the tumour using this "adaptive approach" with the expected doses if no changes are made to the initial plan. This will give us a measure of the benefit of ART. We will also record how much time each re-planning takes to evaluate whether an adaptive approach is feasible in a real world clinical setting.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58538 0
Dr Susan Mincham
Address 58538 0
Radiation Oncology (Genesis Cancer Care)
Fiona Stanley Hospital
102-118 Murdoch Drive
Murdoch WA 6150
Country 58538 0
Australia
Phone 58538 0
+61 8 61524954
Fax 58538 0
Email 58538 0
[email protected]
Contact person for public queries
Name 58539 0
Dr Susan Mincham
Address 58539 0
Radiation Oncology (Genesis Cancer Care)
Fiona Stanley Hospital
102-118 Murdoch Drive
Murdoch WA 6150
Country 58539 0
Australia
Phone 58539 0
+61 8 61524954
Fax 58539 0
Email 58539 0
[email protected]
Contact person for scientific queries
Name 58540 0
Dr Susan Mincham
Address 58540 0
Radiation Oncology (Genesis Cancer Care)
Fiona Stanley Hospital
102-118 Murdoch Drive
Murdoch WA 6150
Country 58540 0
Australia
Phone 58540 0
+61 8 61524954
Fax 58540 0
Email 58540 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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