Research Registry for Intra-Operative Radiotherapy (IORT) During Breast Conserving Surgery in Patients With in Situ and Early Stage Breast Cancer
Saint John's Cancer Institute
Summary
This is a prospective, registry study that will enroll all women with early stage breast cancer who will be treated with intraoperative radiotherapy (IORT) during breast-conserving surgery. The purpose of this study is to further validate the long-term effectiveness and safety of this treatment method. We aim to assess short and long-term patient outcomes associated with IORT, including perioperative complications, local and distance disease recurrences, as well as disease-free survival and overall survival.
Description
At Providence Saint John's Health Center, there is the ongoing integration of Intra-Operative Radiation Therapy (IORT) as a standard treatment option among Breast Conserving Therapy (BCT) for individuals with in situ and early stage breast cancer. Currently, approximately 60 women per year are being treated with IORT. No repository of information of patient outcomes with this treatment has been established. This leaves a critical gap in the ability to assess the long-term outcomes of patients treated with IORT. As the practice of using IORT to treat early stage and in situ breast cancer conti…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Clinical stage Tis, T1, or T2(≤ 3cm), N0, M0 (AJCC Classification) * Unifocal Disease * Candidate for breast-conserving surgery * Recommended treatment by multidisciplinary team Exclusion Criteria: * Clinical stage T3-4, N1-3, M1 * Multifocal disease
Interventions
- RadiationIntraoperative Radiation Therapy (IORT)
IORT involving 50kV Xrays to a dose of 20 Gy during breast-conserving surgery
Location
- John Wayne Cancer Institute, Providence Saint John's Health CenterSanta Monica, California