Status:
TERMINATED
Xoft® Intraoperative Radiotherapy (IORT) for Patients With Early-Stage Breast Cancer
Lead Sponsor:
University of Louisville
Conditions:
Breast Cancer
Breast Cancer, Invasive Ductal
Eligibility:
All Genders
50+ years
Brief Summary
Intraoperative radiotherapy (IORT) is a type of accelerated partial breast irradiation (APBI) in which radiation therapy is delivered to the breast tissue in a single treatment at the time of lumpecto...
Detailed Description
Details of Radiation Therapy: Both breast conserving surgery and IORT will be delivered as per standard practice. Lumpectomy and sentinel lymph node biopsy will be performed by the breast surgeon usin...
Eligibility Criteria
Inclusion
- T1 or T2 invasive carcinoma of the breast undergoing breast conserving surgery
- Clinically lymph node negative and Memorial Sloan Kettering nomogram estimates 20% or less risk of positive sentinel node
- Tumors 2.5 cm or less in size (clinical preoperative staging)
- Estrogen receptor positive tumors (≥10%)
- Her2 negative/not over-expressed
- Patients 50 years of age or greater
Exclusion
- Prior malignancy not in remission
- Active collagen vascular disease requiring active cytotoxic or immunotherapy
- Psychiatric or mental condition which would preclude informed consent
- Prior thoracic radiation which overlaps with IORT field
- Pregnant patients
- Patients \<50 years
- Risk of positive sentinel lymph node \>20% based on nomogram estimates
- Known lymph node metastases (i.e. clinically node positive)
- Patients with invasive lobular carcinoma
- Patients with pure DCIS
- Known multifocal or multicentric tumor
- Patients requiring neoadjuvant chemotherapy
- Patients requiring or choosing mastectomy with or without reconstruction
- Technical contraindications to IORT dose delivery including skin to balloon distance \<7 mm
- Medical contraindication to IORT, radiation or breast conservation
Key Trial Info
Start Date :
September 10 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 5 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04088435
Start Date
September 10 2019
End Date
June 5 2022
Last Update
May 12 2023
Active Locations (1)
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1
James Graham Brown Cancer Center at the University of Louisville
Louisville, Kentucky, United States, 40202