A Pilot Study of CyberKnife Radiosurgery Delivered to the Partial Breast (CK-PBI)

This study has been withdrawn prior to enrollment.

(PI left institution)

Sponsor:

Information provided by:

Georgetown University

ClinicalTrials.gov Identifier:

NCT00529334

First received: September 12, 2007

Last updated: November 19, 2013

Last verified: November 2013

History of Changes

Purpose

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	Intervention
Breast Cancer	Radiation: CyberKnife Partial Breast Irradiation


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer

U.S. FDA Resources

Further study details as provided by Georgetown University:

Primary Outcome Measures:

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. 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 ]


Enrollment:	0
Study Start Date:	September 2007
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility


Ages Eligible for Study:	45 Years and older (Adult, Senior)
Genders 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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


ClinicalTrials.gov Identifier:	NCT00529334 History of Changes
Other Study ID Numbers:	GUMC 2007-153
Study First Received:	September 12, 2007
Last Updated:	November 19, 2013
Health Authority:	United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 26, 2016

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