A Pilot Study of CyberKnife Radiosurgery Delivered to the Partial Breast - Full Text View

Sponsored by:	Georgetown University
Information provided by:	Georgetown University
ClinicalTrials.gov Identifier:	NCT00529334

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

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	A Pilot Study of CyberKnife Radiosurgery Delivered to the Partial Breast for Women With Stage 0, 1, or IIA (<=3cm) Breast Cancer

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 ]

Estimated Enrollment:	10
Study Start Date:	September 2007
Estimated Study Completion Date:	August 2008

Arms	Assigned Interventions
1: Experimental 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
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00529334

Contacts

Contact: Jefferson EC Moulds, MD

202 444-3320

mouldsj@georgetown.edu

Locations

United States, District of Columbia
Georgtown University Medical Center	Recruiting
Washington, District of Columbia, United States, 20057

Sponsors and Collaborators

Georgetown University

Investigators

Principal Investigator:

Jefferson EC Moulds, MD

Georgetown University

More Information

Georgetown University Hospital CyberKnife Center This link exits the ClinicalTrials.gov site

Lombardi Comprehensive Cancer Center Clinical Trials This link exits the ClinicalTrials.gov site

Study ID Numbers:	GUMC 2007-153
Study First Received:	September 12, 2007
Last Updated:	September 12, 2007
ClinicalTrials.gov Identifier:	NCT00529334
Health Authority:	United States: Institutional Review Board

Keywords provided by Georgetown University:

Breast Cancer
Partial breast irradiation
Radiosurgery

CyberKnife
Radiotherapy
PBI

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009