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

Georgetown University

Status: Withdrawn

Conditions: Breast Cancer

Treatments: Radiation: CyberKnife Partial Breast Irradiation

Study type: Interventional

Funder types: Other

Identifiers

NCT00529334

GUMC 2007-153

Details and patient eligibility

About

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.

Sex: Female

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

1

Experimental group

Description:

CyberKnife Partial Breast Irradiation (PBI)

Treatment:

Radiation: CyberKnife Partial Breast Irradiation