Partial-Breast Radiation Therapy in Treating Women With Early-Stage Breast Cancer
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|ClinicalTrials.gov Identifier: NCT01008514|
Recruitment Status : Withdrawn (funding issues and Principal Investigator leaving the institution)
First Posted : November 5, 2009
Last Update Posted : March 26, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: adjuvant therapy Radiation: accelerated partial breast irradiation Radiation: intracavitary balloon brachytherapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 ]
- 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 ]
- Cosmetic results [ Time Frame: up to 30 months ]
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): NCT01008514
|Principal Investigator:||Edward Kim, MD||Ohio State University Comprehensive Cancer Center|