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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COMPLETED
NA
26 participants
INTERVENTIONAL
2010-09-30
2020-04-23
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 with 7 weeks of the lumpectomy and sent/axillary node sampling over the period of five to ten days using the Cyberknife (CK) or within the 7 weeks of the last chemotherapy treatment if given.
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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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Cyberknife for Early Stage Breast Cancer
Cyberknife Robotic Radiosurgery will be utilized as a 5-fraction post-lumpectomy adjuvant radiation treatment in the management of early stage breast cancer.
Cyberknife for Early Stage Breast Cancer
Utilization of Cyberknife Robotic Radiosurgery as a 5-fraction post-lumpectomy adjuvant radiation treatment in the management of early stage breast cancer
Interventions
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Cyberknife for Early Stage Breast Cancer
Utilization of Cyberknife Robotic Radiosurgery as a 5-fraction post-lumpectomy adjuvant radiation treatment in the management of early stage breast cancer
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Negative inked histologic margins of excision or reexcision and clear of invasive tumor and DClS by at least 2mm
* Negative post-excision or post-reexcision mammography if cancer presented with malignancy-associated microcalcifications; no remaining suspicious microcalcifications in the breast before radiotherapy.
* No involved axillary lymph nodes by routine histologic examination (H\&E) of sentinel node(s) or of nodes identified from axillary dissection.
* Enrollment and initiation of CyberKnife therapy within 42 days of last breast cancer surgery or last chemotherapy treatment.
Exclusion Criteria
* Patients with multicentric carcinoma or with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy.
* Patients who are pregnant.
* Patients who have any histologically confirmed positive axillary nodes.
* Patients with collagen vascular diseases, specifically systemic lupus erythematosis, scleroderma, or dermatomyositis with a creatine phosphokinase level above normal or with an active skin rash.
45 Years
45 Years
FEMALE
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Jonathan A. Haas, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Winthrop Hospital
Locations
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NYU Langone Health
New York, New York, United States
Countries
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Related Links
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CyberKnife Radiosurgery for Early-Stage Breast Cancer
University of Texas Southwestern launches clinical trial for treatment of breast cancer using robotic CyberKnife technology
Other Identifiers
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18-01721
Identifier Type: OTHER
Identifier Source: secondary_id
18-01721
Identifier Type: -
Identifier Source: org_study_id
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