NCT00529334

A Pilot Study of CyberKnife Radiosurgery Delivered to the Partial Breast

A Pilot Study of CyberKnife Radiosurgery Delivered to the Partial Breast for Women With Stage 0, 1, or IIA (<=3cm) Breast Cancer

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Georgetown University · Academic / Other
• Sex: Female
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2007-09-14
• Last updated: 2013-11-20

Locations

1 site across 1 country: United States