Registry for Intra-Operative Radiotherapy During Breast Conserving Surgery in Patients With Early Stage Breast Cancer
Recruiting · NCT04603209 · Observational (researchers observe without assigning treatment) · Lead sponsor: Saint John's Cancer Institute
View the official record on ClinicalTrials.gov →Interventions studied
Intraoperative Radiation Therapy (IORT)
What this trial is about
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 can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed across 1 US state.
- John Wayne Cancer Institute, Providence Saint John's Health Center - Santa Monica, California, United States