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.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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

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]

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

Condition category

Condition code

Cancer

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]

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]

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]

On completion of radiotherapy treatment, approximately 7 weeks.

Primary outcome [2]

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]

On completion of radiotherapy treatment, approximately 7 weeks.

Secondary outcome [1]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Fiona Stanley Hospital - Murdoch

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

WA Cancer and Palliative Care Network Cancer Fellowship

Address [1]

Ground Floor, C Block 189 Royal Street
East Perth WA 6004

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Metropolitan Health Service Human Research Ethics Committee

Ethics committee address [1]

Office 212, Level 2, Southern Research Facility
Fiona Stanley Hospital
102-118 Murdoch Drive
Murdoch WA 6150

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

05/05/2015

Approval date [1]

25/06/2015

Ethics approval number [1]

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

Dr Susan Mincham

Address

Radiation Oncology (Genesis Cancer Care)
Fiona Stanley Hospital
102-118 Murdoch Drive
Murdoch WA 6150

Country

Australia

Phone

+61 8 61524954

Fax

Susan.Mincham@health.wa.gov.au

Contact person for public queries

Name

Susan Mincham

Address

Radiation Oncology (Genesis Cancer Care)
Fiona Stanley Hospital
102-118 Murdoch Drive
Murdoch WA 6150

Country

Australia

Phone

+61 8 61524954

Fax

Susan.Mincham@health.wa.gov.au

Contact person for scientific queries

Name

Susan Mincham

Address

Radiation Oncology (Genesis Cancer Care)
Fiona Stanley Hospital
102-118 Murdoch Drive
Murdoch WA 6150

Country

Australia

Phone

+61 8 61524954

Fax

Susan.Mincham@health.wa.gov.au

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

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically