This phase II study based on the Cyberknife Society study will evaluate the technical feasibility and acute toxicity of Partial Breast Irradiation (PBI) with the Cyberknife. It will evaluate quality of life (QOL) issues as they relate to treatment-related side effects, cosmetic result and patient convenience. It will evaluate outcome in terms of local control in the treated breast.
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.
Condition or disease | Intervention/treatment | Phase |
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Early Stage Breast Cancer | Radiation: Cyberknife for Early Stage Breast Cancer | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 26 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Cyberknife Radiosurgery for Early Stage Breast Cancer: A Winthrop-University Hospital Pilot Study of Cyberknife Partial Breast Radiosurgery for Tumors 3 cm or Less |
Actual Study Start Date : | September 2010 |
Actual Primary Completion Date : | September 30, 2014 |
Actual Study Completion Date : | April 23, 2020 |
Arm | Intervention/treatment |
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Experimental: 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.
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Radiation: 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 Name: SBRT (Stereotactic Body Radiation Therapy)
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Ages Eligible for Study: | 45 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
NYU Langone Health | |
New York, New York, United States, 10016 |
Principal Investigator: | Jonathan A. Haas, MD | NYU Winthrop Hospital |
Tracking Information | |||||
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First Submitted Date ICMJE | January 5, 2015 | ||||
First Posted Date ICMJE | May 13, 2019 | ||||
Last Update Posted Date | February 18, 2021 | ||||
Actual Study Start Date ICMJE | September 2010 | ||||
Actual Primary Completion Date | September 30, 2014 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Local Control Rate [ Time Frame: 1 Year ] Mastectomy-free survival rate after Cyberknife body radiosurgery [Mastectomy and death will be considered failures]
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Cyberknife for Early Stage Breast Cancer | ||||
Official Title ICMJE | Cyberknife Radiosurgery for Early Stage Breast Cancer: A Winthrop-University Hospital Pilot Study of Cyberknife Partial Breast Radiosurgery for Tumors 3 cm or Less | ||||
Brief Summary |
This phase II study based on the Cyberknife Society study will evaluate the technical feasibility and acute toxicity of Partial Breast Irradiation (PBI) with the Cyberknife. It will evaluate quality of life (QOL) issues as they relate to treatment-related side effects, cosmetic result and patient convenience. It will evaluate outcome in terms of local control in the treated breast. 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 | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Early Stage Breast Cancer | ||||
Intervention ICMJE | Radiation: 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 Name: SBRT (Stereotactic Body Radiation Therapy)
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Study Arms ICMJE | Experimental: 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.
Intervention: Radiation: Cyberknife for Early Stage Breast Cancer
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
26 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | April 23, 2020 | ||||
Actual Primary Completion Date | September 30, 2014 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 45 Years to 45 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03946683 | ||||
Other Study ID Numbers ICMJE | 18-01721 18-01721 ( Other Identifier: NYU Langone Institutional Review Board ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | NYU Langone Health | ||||
Study Sponsor ICMJE | NYU Langone Health | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | NYU Langone Health | ||||
Verification Date | February 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |