Accelerated Partial Breast Irradiation (APBI) Using Stereotactic Body Radiation Therapy (SBRT)
Recruiting · NCT04985032 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
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
Who can take part
Age range
50 Years to 100 Years
Sex
Female
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Women 50 years or older
- Low to intermediate grade DCIS or invasive ductal carcinoma
- Tumor size \< 2 cm invasive ductal carcinoma and \< 2.5 cm DCIS
- Well defined lumpectomy cavity on CT
- Clear surgical ink margins \> 2mm for invasive cancer and \> 3 mm for DCIS
- Node negative
- Unifocal lesion
- ER and/or PR positive
- HER-2 negative
- BRCA negative
- Lumpectomy cavity must be \< 30% of whole breast volume
Exclusion criteria
- Lobular histology
- Angiolymphatic invasion
- Multiple foci of disease
- Lymphovascular invasion
- Active lupus or sarcoid
- Distant metastases
- Non-epithelial malignancies
- Synchronous contralateral breast cancer
- Grade 2 or higher oncoplastic surgery
- Ipsilateral pacemaker
- Ipsilateral breast implant
- Neoadjuvant chemotherapy
- Prior ipsilateral breast cancer or thoracic radiation
- Poor breast integrity
- Paget's Disease of the nipple
- Pregnant patients
- Severe cardiac, pulmonary, or liver diseases
Where it is running
2 locations listed across 1 US state.
- CyberKnife Center of South Florida in Stuart - Stuart, Florida, United States
- CyberKnife Centers of Tampa Bay - Tampa, Florida, United States