Intra-Operative Radiation Therapy Immediately Following Resection of Early Stage Breast Cancer
This is a physician sponsored multi-center, non-randomized, prospectively enrolling data collection study of patients with early stage breast cancer treated with electronic brachytherapy at the time of surgical resection of the cancer in the operating room. The radiation therapy treatments will be administered with electronic brachytherapy using the FDA cleared Xoft Axxent System.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Intra-Operative Radiation Therapy (IORT) Treatment Immediately Following Resection of Early Stage Breast Cancer|
- Local recurrence in patients treated with intra-operative electronic brachytherapy for early stage breast cancer. [ Time Frame: 5 Years ] [ Designated as safety issue: No ]Local recurrence will be assessed at one (1) month, six (6) months, one (1) year, two (2) years, three (3) years, four (4) years, and five (5) years post IORT.
- Occurence of serious adverse events during and following IORT treatment. [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]
Serious adverse events are defined as a serious injury or illness that:
- is life threatening, even if temporary in nature;
- results in permanent impairment of a body function or permanent damage to a body structure; or
- necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.
- Cosmesis [ Time Frame: 5 Years ] [ Designated as safety issue: No ]Cosmesis will be evaluated with the Harvard scale at one (1) month, six (6) months, and at one (1) year, two (2) years, three (3) years, four (4) years, and five (5) years post IORT.
|Study Start Date:||September 2008|
|Estimated Study Completion Date:||January 2017|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
Experimental: Intra-operative radiation therapy (IORT)
Radiation: Intra-operative radiation therapy (IORT)
All subjects will receive IORT at the time of lumpectomy.
Breast Conserving Therapy (BCT) is a standard treatment option for patients with stage I or II breast cancer. Breast conserving therapy consists of surgical removal of the tumor with negative margins, axillary lymph node dissection or sentinel node biopsy and radiation therapy. Several studies have shown BCT to be comparable to mastectomy in terms of overall and disease free survival for patients. The major advantage to BCT over mastectomy is breast preservation and reduced psychological trauma to the patient. The major disadvantage to BCT is prolonged time of treatment. The whole breast radiation portion of BCT can add 7 weeks to the treatment time. This additional treatment time can be a detriment to women who logistically may not be able to meet the demands of daily irradiation for 6-7 weeks. A new form of treatment, breast brachytherapy, was developed to decrease the treatment time required for breast irradiation. This treatment uses the Xoft Axxent system to administer intra-operative breast brachytherapy in one treatment, at the time of lumpectomy in the operating room.
This study has been designed to assess local recurrence, serious adverse events, adverse events and their severity, and cosmesis following intra-operative radiation therapy (IORT) using the Xoft Axxent System and balloon applicators. The study device is FDA cleared. The purpose of this clinical study is to compile data on the treatment of patients using the Xoft Axxent System for the delivery of radiation therapy in the intra-operative setting as part of breast conserving therapy in women with resected, early stage breast cancer.
|United States, Arizona|
|Cancer Treatment Services Arizona|
|Casa Grande, Arizona, United States, 85122|
|United States, California|
|Long Beach Memorial Medical Center|
|Long Beach, California, United States, 90806|
|Diablo Valley Oncology Hematology|
|Pleasant Hill, California, United States, 94523|
|United States, Florida|
|University South Florida|
|Tampa, Florida, United States, 33612|
|United States, Illinois|
|Little Company of Mary Hospital|
|Evergreen Park, Illinois, United States, 60805|
|Rockford Memorial Hospital|
|Rockford, Illinois, United States, 61103|
|United States, Mississippi|
|University of Mississippi|
|Jackson, Mississippi, United States, 39213|
|United States, New Hampshire|
|Exeter, New Hampshire, United States, 03833|
|United States, Tennessee|
|Chattanooga, Tennessee, United States, 37404|