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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Recruitment Status : Withdrawn (PI left institution)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
Sponsor:
Information provided by:
Georgetown University

Study Description
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Brief Summary:

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • DCIS or infiltrating ductal carcinoma of the breast <= 3cm
  • margins clear by at least 2 mm
  • age >=45 years

Exclusion Criteria:

  • invasive lobular carcinoma
  • multicentric disease
  • nodal metastases
  • breast implants
  • pregnancy
  • connective tissue disease
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
United States, District of Columbia
Georgtown University Medical Center
Washington, District of Columbia, United States, 20057
Sponsors and Collaborators
Georgetown University
Investigators
Principal Investigator: Jefferson EC Moulds, MD Georgetown University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00529334     History of Changes
Other Study ID Numbers: GUMC 2007-153
First Posted: September 14, 2007    Key Record Dates
Last Update Posted: November 20, 2013
Last Verified: November 2013

Keywords provided by Georgetown University:
Breast Cancer
Partial breast irradiation
Radiosurgery
 CyberKnife
Radiotherapy
PBI

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases