RECRUITINGOBSERVATIONAL
Registry for Intra-Operative Radiotherapy During Breast Conserving Surgery in Patients With Early Stage Breast Cancer
Research Registry for Intra-Operative Radiotherapy (IORT) During Breast Conserving Surgery in Patients With in Situ and Early Stage Breast Cancer
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- Clinical stage Tis, T1, or T2(≤ 3cm), N0, M0 (AJCC Classification)
- Unifocal Disease
- Candidate for breast-conserving surgery
- Recommended treatment by multidisciplinary team
Who Should NOT Join This Trial:
- Clinical stage T3-4, N1-3, M1
- Multifocal disease
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
RADIATION
Intraoperative Radiation Therapy (IORT)
IORT involving 50kV Xrays to a dose of 20 Gy during breast-conserving surgery
Locations (1)
John Wayne Cancer Institute, Providence Saint John's Health Center
Santa Monica, California, United States