Feasibility of 3-D Conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage, Node Negative Breast Cancer Patients Using Acculoc Fiducial Markers: A Phase I Trial
- To determine if the delivery of external-beam accelerated partial breast irradiation
(APBI) based on gold fiducial markers is more accurate when compared to the delivery of
radiotherapy based on bony anatomy in women with early-stage, node-negative breast
- To assess the migration of fiducial markers during a course of APBI.
- To quantify the change in the volume of the seroma (lumpectomy) cavity during a course
- To compare overall operative time for suturing fiducial markers into place vs current
standard method of placing surgical clips.
OUTLINE: Patients undergo planned lumpectomy with gold fiducial marker placement (if
procedure not already performed). Patients who meet the post lumpectomy criteria for
continue treatment in this study proceed to accelerated partial breast irradiation (APBI).
Between 15-80 days after surgery, patients undergo 3-dimensional APBI (may be
intensity-modulated radiotherapy) using CT-guided planning (with gold fiducial markers
placed at lumpectomy) once daily, 5 days a week, for 15 days.
Patients undergo fluoroscopy weekly to determine real-time movement of bony anatomy and
fiducial markers and cone-beam CT weekly to determine any change in volume of seroma cavity.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Amount of the shifts of the radiation fields based on bony anatomy as compared to that of gold fiducial markers
During radiation therapy
Bruce G. Haffty, MD
Cancer Institute of New Jersey
United States: Institutional Review Board
|Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School||New Brunswick, New Jersey 08903|