Cyberknife Therapy for Breast Cancer

There has been increasing evidence that breast cancer patients (after a lumpectomy) may not need radiation to the entire breast, but simply radiation to the lumpectomy site (see section on partial breast irradiation or PBI here.)

There is an increase interest in the use of Cyberknife radiosurgery to safely and efficiently deliver partial breast irradiation (see Georgetown protocol below).

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

This study is currently recruiting participants.
Verified by Georgetown University, September 2007

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.

Primary Outcome Measures:
Secondary Outcome Measures:
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.
Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No


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