ACTRN12614000484640
Recruiting
N/A
A pilot Study to assess the feasibility and tolerability of stereotactic ablative body radiosurgery in patients with oligometastases from breast cancer.
Peter MacCallum Cancer Centre0 sites30 target enrollmentMay 9, 2014
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Metastatic Breast Cancer (oligometastatic 1-3 bone metastases)
- Sponsor
- Peter MacCallum Cancer Centre
- Enrollment
- 30
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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