Accelerated Partial Breast Irradiation (APBI) Using Stereotactic Body Radiation Therapy (SBRT): a Multicenter, Observational Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Breast Cosmesis as measured by NRG-Radiation Therapy Oncology Group (RTOG) global cosmetic score (GCS) and the Harvard Cosmesis Scale (HCS)
Study Overview
Brief 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
Detailed 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) documentation. At least three fiducials will be required for target tracking purposes to allow for rotational changes.
Simulation Linear Accelerator SBRT For treatments on a gantry-based linear accelerator, patients will be positioned supine with the arms elevated. CT scans will be obtained with 1.25 mm thickness and will be acquired with free breathing as well as additional scans as needed for motion control or gating. 4DCT, MRI and PET imaging may be used to assist in determining motion estimation.
CyberKnife SBRT For treatment on a robotic system, a contrast enhanced CT simulation is to be performed with 1 mm slices with the patient's arms at her sides in the supine position. The scan is to be performed with end-inspiratory breath hold from the thyroid to below the lungs. Breast immobilization devices including a vacuum mattress and a bra system will be allowed however bolus should not be used. Fiducial tracking (Synchrony) is to be used for motion tracking.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 50 Years to 100 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Breast Cosmesis as measured by NRG-Radiation Therapy Oncology Group (RTOG) global cosmetic score (GCS) and the Harvard Cosmesis Scale (HCS)
Time Frame: 2-3 years
physician and patient assessment of breast cosmetic result following SBRT
Acute breast toxicity as measured by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time Frame: 1-6 weeks
assessment of skin and breast tissue changes during and immediately following SBRT
Other late toxicities as measured by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time Frame: 3-60 months
assessment of pulmonary, cardiac and chest wall changes following SBRT
Secondary Outcomes
No secondary outcomes reported