Status:
COMPLETED
Electronic Xoft Intersociety Brachytherapy Trial: Electronic Brachytherapy (EBT) For Treatment of Early Stage Breast Cancer
Lead Sponsor:
Xoft, Inc.
Conditions:
Breast Cancer
Carcinoma
Eligibility:
FEMALE
50+ years
Phase:
PHASE4
Brief Summary
PRINCIPAL INVESTIGATORS * Rakesh Patel, MD- Radiation Oncologist * Peter Beitsch, MD- Breast Surgeon REGISTRY DESIGN * Multicenter, non-randomized, post market registry of intracavitary accelerated...
Eligibility Criteria
Inclusion
- Patient 50 years of age or older
- Estrogen receptor positive
- Tumor size ≤ 3cm
- Tumor histology: invasive carcinoma or DCIS
- Patient is node negative
- Patient has negative surgical margins (NSABP definition, no tumor on ink) after final surgery
- Life expectancy \> 5 years
Exclusion
- Pregnancy or breast-feeding. (If appropriate, patient must use birth control during the registry.) The need for a pregnancy test is based on the physician's standard practice and will be performed according to the physician's standard of care.
- Collagen Vascular Disease
- Scleroderma
- Systemic sclerosis
- Active lupus
- Infiltrating lobular histology
- Previous ipsilateral radiation to the thorax or breast
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00742222
Start Date
May 1 2008
End Date
January 1 2015
Last Update
May 17 2016
Active Locations (8)
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1
DCH Cancer Treatment Center
Tuscaloosa, Alabama, United States, 35401
2
Beverly Oncology
Montebello, California, United States, 90640
3
Florida Radiation Oncology Group
Orange Park, Florida, United States, 32073
4
St Elizabeth's and Memorial Cancer Center
Swansea, Illinois, United States, 62226