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A pilot study of patients with oligometastases from breast cancer treated with stereotactic ablative body radiosurgery.

Not Applicable
Recruiting
Conditions
Metastatic Breast Cancer (oligometastatic 1-3 bone metastases)
Cancer - Breast
Cancer - Bone
Registration Number
ACTRN12614000484640
Lead Sponsor
Peter MacCallum Cancer Centre
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
30
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.

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

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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