NCT00749437

Radiation Therapy Using Gold Markers in Treating Women With Early-Stage Breast Cancer

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: University of Medicine and Dentistry of New Jersey · Academic / Other
• Sex: Female
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Placing gold markers in the area where the tumor was removed may help doctors better direct radiation therapy and help reduce the risk of cancer recurrence. PURPOSE: This phase I trial is studying how well radiation therapy using gold markers works in treating women with early-stage breast cancer.

Detailed description

OBJECTIVES: Primary * 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 cancer. Secondary * 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 of APBI. * 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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
RADIATION	3-dimensional conformal accelerated partial breast irradiation	Accelerated partial breast irradiation following lumpectomy with placement of Acculoc fiducial markers.

Timeline

• Start date: 2008-10-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2008-09-09
• Last updated: 2012-06-14

Locations

1 site across 1 country: United States