A Pilot Study of CyberKnife Radiosurgery Delivered to the Partial Breast

Withdrawn before enrolling · Not applicable

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00529334

Run by

Georgetown University

People needed

0

Starts

2007-09-01

Expected to finish

2008-09-01

Last updated by the study team

2013-11-20

Who can join

Age: 45 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• invasive lobular carcinoma
• multicentric disease
• nodal metastases
• breast implants
• pregnancy
• connective tissue disease

Where it is running

• Georgtown University Medical Center — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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