Actively Recruiting
Accelerated Partial Breast Irradiation (APBI) Using Stereotactic Body Radiation Therapy (SBRT)
Led by RPCR, Inc. · Updated on 2022-08-05
200
Participants Needed
2
Research Sites
250 weeks
Total Duration
On this page
Sponsors
R
RPCR, Inc.
Lead Sponsor
C
CyberKnife Coalition
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multi-institutional, prospective, observational registry investigating the safety and efficacy of Accelerated Partial Breast Irradiation (APBI) using a Stereotactic Body Radiation Therapy (SBRT) delivery technique that incorporates real-time image guidance, noncoplanar fields, and respiratory tracking. The study will accrue 200 patients who will be treated to a dose of 30 Gy over the course of 5 fractions. These subjects will then have a follow up time of 5 years
CONDITIONS
Official Title
Accelerated Partial Breast Irradiation (APBI) Using Stereotactic Body Radiation Therapy (SBRT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women 50 years or older
- Diagnosed with low to intermediate grade ductal carcinoma in situ or invasive ductal carcinoma
- Tumor size less than 2 cm for invasive ductal carcinoma and less than 2.5 cm for ductal carcinoma in situ
- Clearly visible lumpectomy cavity on CT scan
- Surgical ink margins greater than 2 mm for invasive cancer and greater than 3 mm for ductal carcinoma in situ
- No lymph node involvement (node negative)
- Single tumor lesion (unifocal)
- Estrogen receptor (ER) and/or progesterone receptor (PR) positive
- HER-2 negative
- BRCA gene negative
- Lumpectomy cavity less than 30% of the whole breast volume
You will not qualify if you...
- Lobular histology
- Presence of angiolymphatic invasion
- Multiple tumor foci
- Lymphovascular invasion
- Active lupus or sarcoidosis
- Distant metastases
- Non-epithelial cancers
- Synchronous cancer in the opposite breast
- Oncoplastic surgery grade 2 or higher
- Ipsilateral pacemaker
- Ipsilateral breast implant
- Previous neoadjuvant chemotherapy
- Prior cancer or radiation in the same breast or chest area
- Poor breast tissue integrity
- Paget's Disease of the nipple
- Pregnancy
- Severe heart, lung, or liver disease
AI-Screening
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Trial Site Locations
Total: 2 locations
1
CyberKnife Center of South Florida in Stuart
Stuart, Florida, United States, 33996
Actively Recruiting
2
CyberKnife Centers of Tampa Bay
Tampa, Florida, United States, 33615
Actively Recruiting
Research Team
M
Mark Perman, MD
CONTACT
D
Debra Freeman, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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