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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

February 4, 2011
August 16, 2013
June 2010
June 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01290835 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Conformal Partial Breast Irradiation With CyberKnife After Resection for Early Stage Breast Cancer
Conformal Partial Breast Irradiation With CyberKnife After Resection for Early Stage Breast Cancer

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).

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

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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
Experimental: Stereotactic radiotherapy
Accelerated stereotactic radiotherapy as an adjuvant treatment for early stage breast cancer.
Interventions:
  • Radiation: Stereotactic radiotherapy delivered by CyberKnife
  • Radiation: stereotactic radiotherapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
20
August 2020
June 2015   (final data collection date for primary outcome measure)

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)
Female
60 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01290835
SMDC10101
No
Ken Dornfeld, Essentia Health
Essentia Health
Not Provided
Principal Investigator: Ken Dornfeld, MD Essentia Health Oncology
Essentia Health
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP