NCT01162200

Cyberknife® Partial Breast Irradiation (PBI) for Early Stage Breast Cancer

A Phase I Study of Cyberknife® Partial Breast Irradiation (PBI) for Early Stage Breast Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

By using stereotactic body radiation therapy (SBRT) delivered with the Cyberknife system®, the current protocol attempts to mimic or improve the excellent local control rates seen in treatment of early stage breast cancer while attempting to increase convenience, limit invasiveness, decrease toxicity, and improve cosmesis compared to other methods of radiation treatment.

Conditions

• Early Stage Breast Cancer

Interventions

Type	Name	Description
RADIATION	Stereotactic Body Radiation Therapy	3 dose cohorts. Patients in each dose cohort will all be treated as a single group for dose escalation. The starting dose for the dose escalation portion will be 6 Gy per fraction for 5 fractions (total dose = 30 Gy). Subsequent cohorts of patients will receive an additional 0.5 Gy per treatment (total 2.5 Gy per escalation).

Timeline

• Start date: 2010-10-04
• Primary completion: 2015-07-25
• Completion: 2015-12-28
• First posted: 2010-07-14
• Last updated: 2020-08-20

Locations

2 sites across 1 country: United States