A Pilot Study of CyberKnife Radiosurgery Delivered to the Partial Breast

Not Applicable

Withdrawn

• Conditions: Breast Cancer
• Interventions: Radiation: CyberKnife Partial Breast Irradiation

• Registration Number: NCT00529334
• Lead Sponsor: Georgetown University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-09-12
• Study First Submitted QC: 2007-09-12
• Study First Posted: 2007-09-14
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-19
• Last Update Posted: 2013-11-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	CyberKnife Partial Breast Irradiation	CyberKnife Partial Breast Irradiation (PBI)

Primary Outcome Measures

Name	Time	Method
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	1 year

Secondary Outcome Measures

Name	Time	Method
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.	1 - 5 years

Trial Locations

Locations (1)

Georgtown University Medical Center; 🇺🇸 Washington, District of Columbia, United States