Status:
COMPLETED
Intraoperative Radiation Therapy in Early Stage Breast Cancer
Lead Sponsor:
Benaroya Research Institute
Conditions:
Breast Cancer
Eligibility:
FEMALE
45+ years
Phase:
NA
Brief Summary
Single arm study to assess the effectiveness of single dose intraoperative radiation therapy in patient with in situ and early stage breast cancer.
Detailed Description
The purpose of this clinical study is to assess the effectiveness of IORT, using an electronic brachytherapy system, in patients with limited-volume in situ and early stage breast cancer, with endpoin...
Eligibility Criteria
Inclusion
- General Inclusion Criteria
- Age ≥ 45 years.
- Clinical stage Tis, T1, T2 (≤ 3cm), N0, M0 (AJCC Classification).
- Invasive ductal or lobular carcinoma, DCIS and/ or pleomorphic lobular carcinoma in situ.
Exclusion
- Scleroderma, systemic sclerosis and active lupus.
- Participation in an investigational drug or device study.
- Previous ipsilateral radiation to the thorax or breast.
- Multifocal breast cancer.
- Pregnant patients.
- Patient not competent to provide informed consent.
- Neoadjuvant systemic therapy.
- Lymphovascular invasion on biopsy pathology
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2018
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT02266602
Start Date
February 1 2012
End Date
July 31 2018
Last Update
April 26 2019
Active Locations (1)
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1
Virginia Mason Medical Center
Seattle, Washington, United States, 98101