Status:
TERMINATED
Oncoplastic Partial Mastectomy With Intraoperative Radiation Therapy (IORT) in Early Stage Breast Cancer Patients With Prior History of Chest Wall Radiation.
Lead Sponsor:
Saint John's Cancer Institute
Conditions:
IORT-Intra-Operative Radiation Therapy
Eligibility:
FEMALE
50+ years
Phase:
NA
Brief Summary
Prospective, Non-randomized, Single-arm.The objectives of this study are to evaluate cosmesis and perioperative complications associated with the use of intraoperative radiotherapy (IORT) at the time ...
Eligibility Criteria
Inclusion
- Age ≥ 50 y.o.
- Histologically proven in situ and invasive ductal or lobular breast recurrence
- Prior history of whole breast/chest wall radiation therapy
- Disease span ≤ 3 cm, unifocal
- No nodal disease (N0)
- No evidence of metastatic disease (M0)
- Time from initial BCT should be ≥ 1 year
- Patients have refused the standard of care of mastectomy
- Skin distance of ≥ 0.8 cm between applicator and skin
Exclusion
- Multifocal and/or multicenter recurrence
- N1-3 status: Regional cytological or histologically proven node recurrence
- M1 status: Metastatic disease
- cT4 (Skin or muscle involvement) or Paget's disease of the nipple
- Patients undergoing mastectomy
- Patients undergoing neoadjuvant systemic therapy
- Connective tissue disease or scleroderma, contraindicating radiotherapy
Key Trial Info
Start Date :
December 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 23 2024
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT05289466
Start Date
December 16 2021
End Date
October 23 2024
Last Update
December 31 2025
Active Locations (1)
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1
Providence Saint John's Hospital
Santa Monica, California, United States, 90404