Conformal Partial Breast Irradiation With CyberKnife After Resection for Early Stage Breast Cancer (CK PBI)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Ken Dornfeld, Essentia Health
ClinicalTrials.gov Identifier:
NCT01290835
First received: February 4, 2011
Last updated: August 16, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to determine if it is feasible, safe, and effective to use Cyberknife radiotherapy to deliver partial breast radiotherapy after lumpectomy.Patients meeting eligibility criteria will be invited to participate. Adjuvant radiotherapy will be delivered using CyberKnife radiotherapy using twice daily sessions for five days for a total of ten sessions. Short-term and long-term toxicity will be assessed as well as Tumor control and site of failure (if any).


Condition Intervention Phase
Breast Cancer
Radiation: Stereotactic radiotherapy delivered by CyberKnife
Radiation: stereotactic radiotherapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Conformal Partial Breast Irradiation With CyberKnife After Resection for Early Stage Breast Cancer

Resource links provided by NLM:


Further study details as provided by Essentia Health:

Primary Outcome Measures:
  • To determine the feasibility of using CyberKnife radiotherapy to deliver partial breast radiotherapy for early stage breast cancer. [ Time Frame: one year ] [ Designated as safety issue: No ]
    Subjects will undergo a treatment plan for partial breast irradiation with cyberknife. Feasibility will be determined by monitoring the number of potential eligible subjects enrolled that can be treatedwhile also respecting normal tissue tolerances.


Secondary Outcome Measures:
  • To determine if conformal irradiation to the operative bed using CyberKnife produces acceptable local control [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Subjects will be followed for disease control following standard guidelines that include periodic PE and imaging with either mammograpy or screening breast MRaI for 5 years.


Enrollment: 20
Study Start Date: June 2010
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stereotactic radiotherapy
Accelerated stereotactic radiotherapy as an adjuvant treatment for early stage breast cancer.
Radiation: Stereotactic radiotherapy delivered by CyberKnife
Adjuvant radiotherapy will be delivered using CyberKnife radiotherapy using twice daily sessions for five days for a total of ten sessions.
Other Name: CyberKnife
Radiation: stereotactic radiotherapy

Detailed Description:

This study will determine the feasibility and toxicity of a short course of accelerated radiotherapy as adjuvant treatment for early stage breast cancer. Successful completion of this project may provide a rationale to offer this treatment for select patients with the benefit of potentially less tissue damage and a shorter overall course of therapy. These improvements may ultimately allow more patients the opportunity of breast conserving therapy to treat their cancer

  Eligibility

Ages Eligible for Study:   60 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of breast malignancy, stage T1
  2. Surgical treatment with lumpectomy
  3. age 60 or older
  4. resection margins negative by at least 2mm
  5. any grade
  6. ER positive
  7. unicentric
  8. invasive ductal
  9. pathologic free of nodal metastases (N0, i- or i+)
  10. Post-lumpectomy cavity to whole breast ratio must be less than or equal to 30%

Exclusion criteria

  1. Prior radiotherapy to the breast
  2. Neoadjuvant chemotherapy
  3. multicentric disease
  4. Pure DCIS histology
  5. Presence of extensive intraductal component
  6. Node positive disease (N1 or greater)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01290835

Locations
United States, Minnesota
Essentia Health SMDC Cancer Center
Duluth, Minnesota, United States, 55805
Sponsors and Collaborators
Essentia Health
Investigators
Principal Investigator: Ken Dornfeld, MD Essentia Health Oncology
  More Information

Publications:
Hepel JT, Tokita M, MacAusland SG, Evans SB, Hiatt JR, Price LL, DiPetrillo T, Wazer DE. Toxicity of three-dimensional conformal radiotherapy for accelerated partial breast irradiation. Int J Radiat Oncol Biol Phys. 2009 Dec 1;75(5):1290-6.

Responsible Party: Ken Dornfeld, Radiation Oncologist, Essentia Health
ClinicalTrials.gov Identifier: NCT01290835     History of Changes
Other Study ID Numbers: SMDC10101
Study First Received: February 4, 2011
Last Updated: August 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Essentia Health:
Stereotactic radiotherapy
CyberKnife following lumpectomy
Breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 26, 2014