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

Phase 1

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00749437
• Lead Sponsor: University of Medicine and Dentistry of New Jersey

Brief 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.

Study Timeline

• Study First Submitted: 2008-09-06
• Study First Submitted QC: 2008-09-06
• Study First Posted: 2008-09-09
• Study Start: 2008-10
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-13
• Last Update Posted: 2012-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 34

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Amount of the shifts of the radiation fields based on bony anatomy as compared to that of gold fiducial markers	During radiation therapy

Secondary Outcome Measures

Name	Time	Method
Movement of the fiducial markers themselves and the change in volume of the seroma cavity during a 15-fraction course of accelerated radiotherapy compared with the pre-radiation volume	During radiation therapy

Trial Locations

Locations (1)

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School; 🇺🇸 New Brunswick, New Jersey, United States