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Trial registered on ANZCTR


Registration number
ACTRN12614000484640
Ethics application status
Approved
Date submitted
1/05/2014
Date registered
9/05/2014
Date last updated
6/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study of patients with oligometastases from breast cancer treated with stereotactic ablative body radiosurgery.
Scientific title
A pilot Study to assess the feasibility and tolerability of stereotactic ablative body radiosurgery in patients with oligometastases from breast cancer.
Secondary ID [1] 284524 0
None
Universal Trial Number (UTN)
U1111-1154-1830
Trial acronym
BOSTON
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Breast Cancer (oligometastatic 1-3 bone metastases) 291780 0
Condition category
Condition code
Cancer 292146 292146 0 0
Breast
Cancer 292166 292166 0 0
Bone

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Stereotactic ablative body radiotherapy (SABR) is a new form of cancer treatment involving high precision radiotherapy. Standard radiotherapy treatment is usually delivered in small doses over many treatments (usually 5 to 20 treatments). SABR treatment is different as it uses a dose of radiation delivered in 1 or 2 treatments that is much higher than standard radiotherapy dosages with the aim of destroying all cancer cells at the site of treatment. The total dose of radiation may be 5-10 times higher than standard radiotherapy doses.

SABR treatment appears to be effective in controlling cancer in other sites elsewhere in the body, including the lung, kidney and the liver. We aim to test the ability of this new technique to control the cancer spots that have spread from the breast to the bones and that are being treated with SABR.

Initially you will be assessed to check that you are suitable to join the study. This screening period may last for a number of weeks and will involve the following procedures. All of the tests that you will undergo during this screening period would normally be done as part of your standard care, even if you were not participating in this study.

* Medical history
* Physical examination with a focus on where the cancer has spread to in the body
* CT scan (Chest/Abdomen/Pelvis)
* CT of extremity (only if the cancer is present on an extremity)
* Whole body bone scan
* Other investigations, for example an MRI scan (magnetic resonance imaging) may be ordered by your doctor

Also as part of this study you will be required to have a special scan called an 18F-PET/CT (stands for fluoride-positron emission tomography/computer tomography) scan. This involves an injection of a radioactive material/tracer and then a scan to see where your breast cancer has spread to.

If the tests show that the research study is suitable for you, and you still wish to take part, you can join the study and begin the treatment.

You will have either a single session of SABR treatment (20Gy in 1 fraction per area to be treated) or in some cases where there is not enough time available or for technical reasons you may be required to return for two or three sessions (i.e. You may receive 28Gy in 2 fractions).

In order to deliver this treatment, you may need to attend a ‘planning CT scan’ session, where you will receive a CT scan and your body measurements are taken in the position that you will be lying in for your radiotherapy. This visit takes approximately one hour. Once the radiotherapy treatment has been planned, a further ‘mock-up’ visit may be required to ensure that the radiotherapy plan can be smoothly delivered when it comes to the time of treatment. This session will take between 45 minutes and 90 minutes. When the treatment starts, the total time required to deliver the treatment will be approximately one hour.

Follow-up will involve a visit at approximately 1 month, and every 3 months until two years after the SABR treatment. At each visit, a doctor will review your general health and whether anything new has happened to you since the last study visit (including any bad reactions or injuries), any side effect’s you may be experiencing, an assessment of how well you can perform daily activities and a review of any further anti-cancer treatments you may have undergone.

At 12 and 24 months after your SABR treatment, you will have a CT scan and whole body bone scan, as well as a another 18F-PET/CT scan (at 12 months only), which will be very similar to the scan before your treatment. The purpose of this scan is to assess the effect of the treatment on your bone lesion(s).
Intervention code [1] 289284 0
Treatment: Other
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292022 0
To assess the feasibility of SABR in breast cancer patients with oligometastatic breast cancer (up to 3 bone metastases).
Timepoint [1] 292022 0
Feasibility will be considered to have been achieved for a given patient if both of the following conditions hold true for that patient:

a) Successful completion of treatment within 3 days of intended treatment completion

b) Image guidance verification of treatment delivery within 5mm of planned delivery

Feasability will be assessed following completion of study treatment.
Primary outcome [2] 292023 0
To assess the tolerability of SABR in breast cancer patients with oligometastatic breast cancer (up to 3 bone metastases).
Timepoint [2] 292023 0
Tolerability will be considered to have been achieved for the overall cohort of patients recruited into the study, if:
a) No greater than 15% (4 of 30) of the patients will experience a grade 3 or higher acute toxicity (that is within 3 months of SABR treatment)

b)There are no grade 5 toxicities related to SABR


Tolerability will be assessed following completion of study related follow-up (~2 years from the date of the last patient recruitment).
Secondary outcome [1] 308021 0
a) To assess acute toxicity
Timepoint [1] 308021 0
a) Acute toxicities (that is toxicities within 3 months of SABR) using CTCAE V4.0
Secondary outcome [2] 308068 0
b) To estimate effectiveness of treatment

To estimate the effectiveness of treatment - local progression free survival (LPFS) will be evaluated based on all available imaging performed (CT, Bone Scan, MRI, 18F-PET Scan etc).
Timepoint [2] 308068 0
b) Effectiveness of treatment: Local progression free survival (LPFS)

LPFS (via available imaging) will be assessed at 1, 3, 6, 9, 12, 15, 18, 21 and 24 months post end of SABR treatment.

Eligibility
Key inclusion criteria
* Aged > 18 years.
* Has provided signed written informed consent for participation in this trial.
* Histological or cytologically confirmed breast cancer.
* Primary breast cancer controlled.
* Whole Body Bone Scan (WBBS), CT Scan (Chest, Abdo + Pelvis) and Na-18F PET Scan evidence of 1 to 3 active metastases (bone only) within 8 weeks of study registration.
* An ECOG performance status score of 2 or less.
* Life expectancy greater than 12 months.
* Willing and able to comply with all study requirements, including treatment, attending required assessments and follow-up.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Previous high dose radiotherapy (BED > 20Gy) to an area to be treated which includes vertebral bodies
* Visceral Metastases (e.g. liver, lung or brain)
* Treatment with any chemotherapy agent within +/- 3 weeks of SABR
* Evidence of Spinal Cord Compression.
* Spinal Instability Neoplastic Score greater than or equal 7 unless lesion reviewed by a neurosurgical service and considered stable. A dose of 28Gy in 2 fractions can be considered after review at SABR chart round.
* Surgical fixation of lesion required for stability.
* Lesion in a long bone (femur or humerus) which involves the cortex.

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)
Following informed consent, the Participant Information & Consent Form will be signed and dated (with a witness). Once it is confirmed that the patient meets all inclusion criteria and none of the exclusion criteria, they will be registered onto the study. This is a non-randomised trial and there are no allocation concealment procedures.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A - This is a non-randomised study.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
This is a single institution, single arm pilot study to determine feasibility and tolerability of SABR in patients with oligometastatic breast cancer.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Primary Aim:
The point estimate for feasibility as a binary variable will be provided along with its 95% CI. Feasibility will be considered to have been achieved for a given patients if all of the following conditions hold true for that patient:
a) Successful completion of treatment within 3 days of intended treatment
b) Image guidance verification of treatment delivery within 5mm

The point estimate for tolerability as a binary variable will be provided along with its exact 95% CI.
The treatment will be considered tolerable if:
a) No greater than 15% (4 of 30) of the patients will experience a grade III or higher acute toxicity
b) There will be no grade 5 toxicities related to SABR

Secondary Aims:
The proportion of patients who suffer from grade 3 or higher acute toxicities will be provided along with its exact 95% CI. Acute toxicities will include those under the following categories:
* Gastrointestinal Disorders
* General Disorders and Administration Site Conditions
* Hepatobiliary Disorders
* Musculoskeletal and Connective Tissue Disorders
* Neoplasms Benign, Malignant and Unspecified (incl cysts and polyps)
* Renal and Urinary Disorders
* Respiratory, Thoracic and Mediastinal Disorders
* Skin and Subcutaneous Tissue Disorders

The effectiveness of treatment will be assessed by means of the local progression free survival (LPFS). Kaplan-Meier methods will be used to describe LPFS. LPFS at 1 and 2 years will be estimated from the Kaplan-Meier curve, along with the corresponding 95% confidence interval.

A trained PET physician will provide a visual analysis of Na-18F PET scans. Na-18F PET response will be described at 12 months as counts and percentages with exact 95% confidence intervals. This exploratory analysis will be restricted to patients alive and not lost to follow-up at 12 months.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2014
Actual
29/09/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2388 0
Peter MacCallum Cancer Centre
Recruitment hospital [2] 4585 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment postcode(s) [1] 8041 0
3165 - Bentleigh East
Recruitment postcode(s) [2] 12190 0
3002 - East Melbourne

Funding & Sponsors
Funding source category [1] 289159 0
Charities/Societies/Foundations
Name [1] 289159 0
National Breast Cancer Foundation
Country [1] 289159 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
C/O Monash Cancer Centre
Radiation Oncology and Cancer Imaging
823-865 Centre Road,
East Bentleigh, VIC 3165
Country
Australia
Secondary sponsor category [1] 287825 0
None
Name [1] 287825 0
Address [1] 287825 0
Country [1] 287825 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290932 0
Peter MacCallum Cancer Centre Ethics Committee
Ethics committee address [1] 290932 0
Locked Bag 1, A'Beckett Street, VIC, Australia, 8006
Ethics committee country [1] 290932 0
Australia
Date submitted for ethics approval [1] 290932 0
01/05/2014
Approval date [1] 290932 0
07/05/2014
Ethics approval number [1] 290932 0
PMCC HREC # 14/24

Summary
Brief summary
This study aims to investigate the feasibility and tolerability of stereotactic ablative body radiosurgery in patients with oligometastases from breast cancer.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above and have a confirmed primary diagnosis of breast cancer, with evidence of 1 to 3 bone metastases.

Study details:
Stereotactic ablative body radiotherapy (SABR) is a new form of cancer treatment involving high precision radiotherapy. Standard radiotherapy treatment is usually delivered in small doses over many treatments (usually 5 to 20 treatments). SABR treatment is different as it uses a dose of radiation delivered in 1 or 2 treatments that is much higher than standard radiotherapy dosages with the aim of destroying all cancer cells at the site of treatment. The total dose of radiation may be 5-10 times higher than standard radiotherapy doses. SABR treatment appears to be effective in controlling cancer in other sites elsewhere in the body, including the lung, kidney and the liver. All participants in this study will be treated with SABR delivered in 1-3 sessions of 45-90 minutes duration. Participants will be regularly monitored during treatment and for a period of up to 24 months post treatment in order to evaluate the feasibility and tolerability of treatment, as well as treatment response.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48042 0
Dr Steven David
Address 48042 0
Peter MacCallum Cancer Centre,
C/O Monash Cancer Centre,
Department of Radiotherapy,
823-865 Centre Road,
East Bentleigh, VIC 3165
Country 48042 0
Australia
Phone 48042 0
+61 3 9928-8901
Fax 48042 0
+61 3 9928-8918
Email 48042 0
[email protected]
Contact person for public queries
Name 48043 0
Steven David
Address 48043 0
Peter MacCallum Cancer Centre,
C/O Monash Cancer Centre,
Department of Radiotherapy,
823-865 Centre Road,
East Bentleigh, VIC 3165
Country 48043 0
Australia
Phone 48043 0
+61 3 9928-8951
Fax 48043 0
+61 3 9928-8918
Email 48043 0
[email protected]
Contact person for scientific queries
Name 48044 0
Steven David
Address 48044 0
Peter MacCallum Cancer Centre,
C/O Monash Cancer Centre,
Department of Radiotherapy,
823-865 Centre Road,
East Bentleigh, VIC 3165
Country 48044 0
Australia
Phone 48044 0
+61 3 9928-8901
Fax 48044 0
+61 3 9928-8918
Email 48044 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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No documents have been uploaded by study researchers.

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