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

NCT01162200 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2020-08-20

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Asal Rahimi, MD · UT Southwestern Medical Center Dallas

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-04
Primary Completion
2015-07-25
Completion
2015-12-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01162200 on ClinicalTrials.gov