Radiation Therapy Using Gold Markers in Treating Women With Early-Stage Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00749437|
Recruitment Status : Completed
First Posted : September 9, 2008
Last Update Posted : June 14, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Radiation: 3-dimensional conformal accelerated partial breast irradiation||Phase 1|
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||July 2010|
- Radiation: 3-dimensional conformal accelerated partial breast irradiation
Accelerated partial breast irradiation following lumpectomy with placement of Acculoc fiducial markers.
- Amount of the shifts of the radiation fields based on bony anatomy as compared to that of gold fiducial markers [ Time Frame: During radiation therapy ]
- 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 [ Time Frame: During radiation therapy ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00749437
|United States, New Jersey|
|Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School|
|New Brunswick, New Jersey, United States, 08903|
|Principal Investigator:||Bruce G. Haffty, MD||Rutgers Cancer Institute of New Jersey|