A Pilot Study of CyberKnife Radiosurgery Delivered to the Partial Breast (CK-PBI)
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|ClinicalTrials.gov Identifier: NCT00529334|
Recruitment Status : Withdrawn (PI left institution)
First Posted : September 14, 2007
Last Update Posted : November 20, 2013
This pilot study will evaluate the technical feasibility and acute toxicity of Partial Breast Irradiation (PBI) with the CyberKnife in anticipation of a larger multi-institutional Phase II study. It will evaluate quality of life (QOL) issues as they relate to treatment related side effects, cosmetic result, and patient convenience.
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Radiation: CyberKnife Partial Breast Irradiation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of CyberKnife Radiosurgery Delivered to the Partial Breast for Women With Stage 0, 1, or IIA (<=3cm) Breast Cancer|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||September 2008|
CyberKnife Partial Breast Irradiation (PBI)
Radiation: 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.
- 1. To evaluate the feasibility of CyberKnife body radiosurgery as the sole radiation therapy for this patient population 2. To evaluate the complication rate of CyberKnife body radiosurgery as the sole radiation therapy for this patient population [ Time Frame: 1 year ]
- 1. To evaluate the local control rate of CyberKnife body radiosurgery as the sole radiation therapy for this patient population. 2. To evaluate Quality of Life after CyberKnife body radiosurgery PBI. [ Time Frame: 1 - 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00529334
|United States, District of Columbia|
|Georgtown University Medical Center|
|Washington, District of Columbia, United States, 20057|
|Principal Investigator:||Jefferson EC Moulds, MD||Georgetown University|