Partial-Breast Radiation Therapy in Treating Women With Early-Stage Breast Cancer
RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. It may also cause less damage to normal tissue.
PURPOSE: This phase II trial is studying how well partial-breast radiation therapy works in treating women with early-stage breast cancer.
Procedure: adjuvant therapy
Radiation: accelerated partial breast irradiation
Radiation: intracavitary balloon brachytherapy
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Single Institution, Prospective, Non-randomized Study of Partial Breast Irradiation Using the MammoSite Radiation Therapy System (Breast Brachytherapy Applicator)|
- Proportion of local recurrence [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
- Local recurrence is defined as either invasive or non-invasive local recurrence within the target volume.
- Ipsilateral elsewhere recurrence is defined as either invasive or non-invasive local recurrence outside of the target volume.
- Safety and toxicity [ Time Frame: up to 30 months after radiotherapy ] [ Designated as safety issue: Yes ]
- Cosmetic results [ Time Frame: up to 30 months ] [ Designated as safety issue: No ]
- To examine the efficacy of MammoSite® Radiation Therapy System (RTS) in delivering partial-breast irradiation to women with early-stage breast cancer.
- To assess the toxicities associated with MammoSite® RTS in these patients.
- To evaluate the cosmetic results in the breast after brachytherapy with the MammoSite® RTS.
- To correlate the cosmetic results with the use of chemotherapy, volume of the implant, and distance from the implant to the skin.
- To correlate the local recurrence rate with time between surgery and implant.
OUTLINE: Patients undergo placement of the MammoSite® Radiation Therapy System (RTS) device into the cavity where the tumor was removed either at the time of surgery or percutaneously under ultrasound guidance after surgery. Within 2-5 days after the device implant, patients undergo partial-breast irradiation delivered by MammoSite® RTS twice daily for 5 days.
After completion of study therapy, patients are followed up periodically for 5 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01008514
|Principal Investigator:||Edward Kim, MD||Ohio State University Comprehensive Cancer Center|