Registry for Intra-Operative Radiotherapy During Breast Conserving Surgery in Patients With Early Stage Breast Cancer
Recruiting now
Conditions studied: Early-stage Breast Cancer, Breast Carcinoma in Situ, Breast Neoplasms
In brief
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.
Key facts
- Study ID
- NCT04603209
- Run by
- Saint John's Cancer Institute
- People needed
- 1000
- Starts
- 2018-10-03
- Expected to finish
- 2028-10-03
- Last updated by the study team
- 2024-04-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Clinical stage Tis, T1, or T2(≤ 3cm), N0, M0 (AJCC Classification)
- Unifocal Disease
- Candidate for breast-conserving surgery
- Recommended treatment by multidisciplinary team
You may not qualify if…
- Clinical stage T3-4, N1-3, M1
- Multifocal disease
Where it is running
- John Wayne Cancer Institute, Providence Saint John's Health Center — Santa Monica, California, United States (enrolling)
Full record on ClinicalTrials.gov
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