Accelerated Partial Breast Irradiation (APBI) Using Stereotactic Body Radiation Therapy (SBRT): a Multicenter, Observational Clinical Trial
RPCR, Inc.
Summary
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
Description
RADIATION TREATMENT GUIDELINES and DOSIMETRY Fiducial Placement Prior to enrollment, patients will undergo breast conservation surgery preferably with fiducial markers implanted at the time of surgery or under ultrasonic guidance25 Patients treated with gantry-based SBRT preferably will have fiducials placed at the time of surgery. For patients being treated with CyberKnife SBRT, four gold markers will be placed intraoperatively or ultrasonically to define the superior, inferior, medial, and lateral boundaries of the lumpectomy cavity in accordance with the manufacturer's (Accuray) documenta…
Eligibility
- Age range
- 50–100 years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Women 50 years or older 2. Low to intermediate grade DCIS or invasive ductal carcinoma 3. Tumor size \< 2 cm invasive ductal carcinoma and \< 2.5 cm DCIS 4. Well defined lumpectomy cavity on CT 5. Clear surgical ink margins \> 2mm for invasive cancer and \> 3 mm for DCIS 6. Node negative 7. Unifocal lesion 8. ER and/or PR positive 9. HER-2 negative 10. BRCA negative 11. Lumpectomy cavity must be \< 30% of whole breast volume Exclusion Criteria: 1. Lobular histology 2. Angiolymphatic invasion 3. Multiple foci of disease 4. Lymphovascular invasion 5. Active lupus or sar…
Interventions
- Radiationstereotactic body radiation therapy
Treatment technique used to deliver a highly focused and accurate radiation dose to a defined target volume outside the brain; the entire course of therapy delivered in five fractions or less
Locations (2)
- CyberKnife Center of South Florida in StuartStuart, Florida
- CyberKnife Centers of Tampa BayTampa, Florida