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Trial registered on ANZCTR


Registration number
ACTRN12620000257965p
Ethics application status
Submitted, not yet approved
Date submitted
28/01/2020
Date registered
27/02/2020
Date last updated
27/02/2020
Date data sharing statement initially provided
27/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A Study Assessing Delivery Of Prone Radiotherapy As A New Technique To Minimise Patient Toxicity In Patients With Invasive Breast Cancer
Scientific title
A Pilot Study of Prone Position Neoadjuvant Breast Radiotherapy to Reduce Skin Toxicity
Secondary ID [1] 299702 0
18/045
Universal Trial Number (UTN)
U1111-1242-9323
Trial acronym
PIONEER Study
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Invasive, Grade 1, 2 or 3 Breast carcinoma 315051 0
Primary Tumour is T2, T3 or T4 and N1+ 315988 0
Condition category
Condition code
Cancer 313383 313383 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study participant will need to be suitable for radiotherapy in the prone position assessed by a clinician. Radiotherapy treatment will take place at least 4 weeks after completion of chemotherapy and will be administered by radiotherapy team which includes radiation oncologist, radiation therapist, medical physicist and nurses.
Approximately 1 hour Planning Radiotherapy session will take place 1-2 weeks before the commencement of radiotherapy treatment. The plan will be audited by a second breast planner.Chart round review by the clinicians, physicists and radiation therapists.
Radiotherapy in the Prone Position will be delivered five days a week from Monday to Friday over 5 weeks (25 fractions, 2Gy/fraction).
Clinical assessments will be performed once a week during the treatment and then 2 and 4 weeks after radiotherapy completion. Each visit will take approximately 1 hour.
Surgery to remove the breast and the immediate breast reconstruction will be performed 4-8 weeks after completion of radiotherapy.
Post surgery clinical assessment will be performed by a surgeon approximately 30 days after the surgery. This will be the last study visit for each participant.
Intervention code [1] 315964 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321866 0
Successful delivery of prone radiotherapy defined as the ability to deliver at least 95% of the prescribed dose to 95% of the primary tumour PTV whilst meeting Organ at Risk (OAR) constraints. Based on the radiation dosimetry and calculated by the radiation planning software.
Timepoint [1] 321866 0
End of radiotherapy
Primary outcome [2] 321867 0
Number of patients who meet planning parameters to achieve the highest dose level. Based on the radiation dosimetry and calculated by the radiation planning software.
Timepoint [2] 321867 0
End of radiotherapy
Secondary outcome [1] 376525 0
Successful delivery of prone radiotherapy defined as the ability to deliver at least 95% of the prescribed dose to 95% or greater of the whole breast Planning Target Volume (PTV) and nodal PTV within constraints. Based on the radiation dosimetry and calculated by the radiation planning software.
Timepoint [1] 376525 0
End of radiotherapy
Secondary outcome [2] 376735 0
pCR at time of surgery measured according to Residual Cancer Burden Calculator - MD Anderson
Timepoint [2] 376735 0
At the time of surgery. Approximately four weeks after radiotherapy completion.
Secondary outcome [3] 376736 0
Incidence of Grade 3 or greater acute skin toxicity as per CTCAE v5.0 criteria
Timepoint [3] 376736 0
At the time of surgery. Approximately four weeks after radiotherapy completion.
Secondary outcome [4] 376737 0
Patient experience of prone positioning for radiotherapy planning and delivery assessed using the PIONEER PRONE patient radiotherapy questionnaire designed specifically for this study.
Timepoint [4] 376737 0
Patients already enrolled will have radiotherapy planning (1-2 weeks before the treatment start day).
Secondary outcome [5] 376738 0
The total time spent planning radiotherapy in hours by all professionals involved in the planning process. If planning has to be repeated for whatever reason, all planning time will be included both original and repeated. Recorded automatically by the radiotherapy planning software.
Timepoint [5] 376738 0
At the end of planning, 1-2 weeks before the start of study treatment .
Secondary outcome [6] 376739 0
Surgical morbidity evaluated using Clavien-Dindo classification
Timepoint [6] 376739 0
30 days post surgery
Secondary outcome [7] 376740 0
Categories 3 or higher on the Clavien-Dindo classification regarded as surgical complications. In addition the following specific surgical complications will be assessed during the clinical examination:
Full thickness native breast skin necrosis
Full thickness native nipple necrosis
Microvascular thrombosis rate
Timepoint [7] 376740 0
30 days post surgery

Eligibility
Key inclusion criteria
Patient has provided written informed consent for the trial
Female patients greater than or equal 18 years of age on day of signing informed consent
Patient has histologically confirmed invasive, Grade 1, 2 or 3 breast carcinoma
Primary tumour is T2, T3 or T4 and N1+
Patient is a candidate for radiotherapy in the prone position and mastectomy with immediate autologous reconstruction as assessed by the breast surgeon, the plastic surgeon and the radiation oncologist
Patient has received neoadjuvant systemic therapy, including chemotherapy and/or targeted therapies
Patient ECOG Performance status of 0 or 1
Patient is willing and able to comply with the protocol requirements for the duration of the study including undergoing radiotherapy, surgery, scheduled visits and follow up
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Inflammatory breast cancers with documented skin involvement
Presence of ductal carcinoma in situ (DCIS) alone
Pregnant or lactating patients
Contraindication to radiotherapy e.g. scleroderma
Prior radiotherapy which precludes giving radiotherapy with curative intent to breast and locoregional nodes

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)
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
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)
VIC
Recruitment hospital [1] 15088 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 28385 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 304176 0
Charities/Societies/Foundations
Name [1] 304176 0
Victorian Comprehensive Cancer Council (VCCC)
Address [1] 304176 0
Level 10
305 Grattan Street
Melbourne VIC 3000
Country [1] 304176 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
305 Grattan Street
Melbourne VIC 3000
Country
Australia
Secondary sponsor category [1] 304409 0
None
Name [1] 304409 0
Address [1] 304409 0
Country [1] 304409 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304648 0
Peter MacCallum Cancer Centre HREC
Ethics committee address [1] 304648 0
Level 8
305 Grattan Street
Melbourne VIC 3000
Ethics committee country [1] 304648 0
Australia
Date submitted for ethics approval [1] 304648 0
02/12/2019
Approval date [1] 304648 0
Ethics approval number [1] 304648 0

Summary
Brief summary
This study aims to determine the best way of delivering radiation therapy to the breast tissue before surgery. In order to do that, women will lay in a prone position (on the stomach), so that the breast can fall naturally forward and away from the chest. The cancer inside the breast tissue is treated to a very high dose before it is removed. The aim is to minimise skin toxicities to help the surgeons perform the operation and reconstruction, all in one surgery.

Who is it for?
You may be eligible to join this study if you are aged 18 years or older and have a histologically confirmed invasive, Grade 1, 2 or 3 breast carcinoma with a Primary tumour graded as T2, T3 or T4 and N1+.

Study details
This study will take about 1 year to recruit 20 participants suitable for radiotherapy in the prone position. On average, the total study duration is expected to be 3 months for each participant.
Radiotherapy treatment will commence at least 4 weeks after completion of standard chemotherapy and it will be delivered in the prone position, five days a week from Monday to Friday, over 5 weeks (25 fractions, 2Gy/fraction).
One week before the radiotherapy treatment, the Radiotherapy Planning will be booked and the session will take approximately 1 hour.
During the study, clinical assessments will be performed once a week during the treatment and then 2 and 4 weeks after radiotherapy completion. Each visit will take approximately 1 hour.
4-8 weeks following successful completion of radiotherapy participant will have a surgery to remove the breast and immediate breast reconstruction. 30 days after the surgery each patient will have their last study visit - post surgical assessment to evaluate any side effects and surgical complications.

It is hoped that information from this study may help improve the treatment for other patients with invasive type of breast cancer in the future and will help evaluate the new position and treatment doses for future breast radiotherapy treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97718 0
Dr Fiona Hegi-Johnson
Address 97718 0
Peter MacCallum Cancer Centre
305 Grattan St
Melbourne, Victoria
3000 Australia
Country 97718 0
Australia
Phone 97718 0
+61 03 8559 7744
Fax 97718 0
Email 97718 0
fiona.hegi-johnson@petermac.org
Contact person for public queries
Name 97719 0
Dr Fiona Hegi-Johnson
Address 97719 0
Peter MacCallum Cancer Centre
305 Grattan St
Melbourne, Victoria
3000 Australia
Country 97719 0
Australia
Phone 97719 0
+61 03 8559 7744
Fax 97719 0
Email 97719 0
fiona.hegi-johnson@petermac.org
Contact person for scientific queries
Name 97720 0
Dr Fiona Hegi-Johnson
Address 97720 0
Peter MacCallum Cancer Centre
305 Grattan St
Melbourne, Victoria
3000 Australia
Country 97720 0
Australia
Phone 97720 0
+61 03 8559 7744
Fax 97720 0
Email 97720 0
fiona.hegi-johnson@petermac.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Applications to access data for secondary studies or other research purposes can be forwarded to the sponsor for consideration.
When will data be available (start and end dates)?
From 3 months to up to 3 years following main publication.
Available to whom?
This will be considered on case-by-case basis.
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Data can be obtained by emailing the sponsor.
What supporting documents are/will be available?
No other documents available
Summary results
No Results