Actively Recruiting
SBRT for Breast Cancer Oligometastases
Led by King Hussein Cancer Center · Updated on 2020-06-11
50
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective data collection of treatment outcome for newly diagnosed oligometastatic breast cancers with 1-3 bone metastases. Eligible patients will be identified from the weekly Breast MDC. Patients will receive the recommended systemic and local treatment (including metastases directed SBRT) according to our clinical practice guidelines.Patients will be followed according to our routine with clinical and radiologic assessment. It is preferred that the same imaging method that was used to originally detect the metastases be used in follow-up assessments. The first imaging for SBRT sites will be three months post SBRT and every three months for the first year, every 6 months for the second year, then annually. Response and progression for these metastases will be evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions is used in the RECIST criteria. If functional imaging (bone scan, PET) were used at staging, changes in the uptake will be used in follow up scans to determine response to treatment and progression. As for SBRT related morbidities, we will use the Common Terminology Criteria for Adverse Events (CTCAE v5) for toxicity reporting and scoring.
CONDITIONS
Official Title
SBRT for Breast Cancer Oligometastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women older than 18 years with pathologically confirmed breast cancer presenting with 1-3 bone metastases
- Metastases confirmed by pathology if possible, or by two different imaging methods (CT or MRI plus bone scan or PET)
- Ability to receive recommended systemic and local treatments
- Primary breast tumor must be controlled at time of SBRT
- Each metastasis must be 5 cm or smaller in any dimension
- Metastases must be more than 5 cm apart from each other (edge to edge)
You will not qualify if you...
- Breast cancer metastases not limited to bone
- Prior radiotherapy to the same sites planned for SBRT
- Pathologic fractures of bones involved
- Contraindications to radiotherapy such as pregnancy or connective tissue diseases
- Patients with impaired cognitive function
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
King Hussein Cancer Center
Amman, Jordan, 11941
Actively Recruiting
Research Team
A
Abdulmajeed H Dayyat, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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