Study Results
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View full resultsBasic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2007-03-26
2016-05-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
This is a single arm study where all patients are treated with FDA cleared electronic brachytherapy treatment.
Electronic brachytherapy (Axxent System)
3.4 Gy per fraction for 10 fractions for a total of 34 Gy.
Interventions
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Electronic brachytherapy (Axxent System)
3.4 Gy per fraction for 10 fractions for a total of 34 Gy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Tumor with Tis, T1, N0, M0 - (AJC Classification)
* Invasive ductal carcinoma or ductal carcinoma in situ
* Negative microscopic surgical margins of at least 1mm in all directions
* Adequate skin spacing between balloon surface and surface of the skin - (\> 7mm)
Exclusion Criteria
* Scleroderma, systemic sclerosis and active lupus
* Infiltrating lobular histology
50 Years
FEMALE
No
Sponsors
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Xoft, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Vivek K Mehta, MD
Role: PRINCIPAL_INVESTIGATOR
Swedish Cancer Institute
Locations
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Mills Peninsula Hospital
San Mateo, California, United States
Wellstar-Kennestone Cancer Center
Marietta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Little Company of Mary Hospital
Evergreen Park, Illinois, United States
Holy Cross Medical Center
Silver Spring, Maryland, United States
Beth Israel Medical Center
New York, New York, United States
Dickstein Cancer Center- White Plains Hospital
White Plains, New York, United States
Oklahoma University Health Science Center
Oklahoma City, Oklahoma, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Swedish Cancer Institute
Seattle, Washington, United States
Countries
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References
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Mehta VK, Algan O, Griem KL, Dickler A, Haile K, Wazer DE, Stevens RE, Chadha M, Kurtzman S, Modin SD, Dowlatshahi K, Elliott KW, Rusch TW. Experience with an electronic brachytherapy technique for intracavitary accelerated partial breast irradiation. Am J Clin Oncol. 2010 Aug;33(4):327-35. doi: 10.1097/COC.0b013e3181d79d9e.
Other Identifiers
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1-04
Identifier Type: -
Identifier Source: org_study_id
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