A Pilot Study of CyberKnife Radiosurgery Delivered to the Partial Breast
NCT ID: NCT00529334
Last Updated: 2013-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2007-09-30
2008-09-30
Brief Summary
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Radiosurgery is defined as the stereotactic delivery of ionizing radiation in 5 stages or less to a designated target with sub-millimeter accuracy. Radiosurgery in the context of this protocol will be given to the region of the tumor bed within 7 weeks of lumpectomy and sentinel/axillary node sampling over a period of five to ten days using the CyberKnife (CK). Subjects will receive CK before chemotherapy, if applicable.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
CyberKnife Partial Breast Irradiation (PBI)
CyberKnife Partial Breast Irradiation
Body radiosurgery will be delivered to the lumpectomy cavity with specified margin. Radiation dose will be 600 cGy x 5 stages = 3000 cGy over five to ten total days.
Interventions
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CyberKnife Partial Breast Irradiation
Body radiosurgery will be delivered to the lumpectomy cavity with specified margin. Radiation dose will be 600 cGy x 5 stages = 3000 cGy over five to ten total days.
Eligibility Criteria
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Inclusion Criteria
* margins clear by at least 2 mm
* age \>=45 years
Exclusion Criteria
* multicentric disease
* nodal metastases
* breast implants
* pregnancy
* connective tissue disease
45 Years
FEMALE
No
Sponsors
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Georgetown University
OTHER
Principal Investigators
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Jefferson EC Moulds, MD
Role: PRINCIPAL_INVESTIGATOR
Georgetown University
Locations
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Georgtown University Medical Center
Washington D.C., District of Columbia, United States
Countries
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Other Identifiers
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GUMC 2007-153
Identifier Type: -
Identifier Source: org_study_id