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

Primary Purpose

Breast Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stereotactic radiotherapy delivered by CyberKnife
stereotactic radiotherapy
Sponsored by
Essentia Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Stereotactic radiotherapy, CyberKnife following lumpectomy, Breast cancer

Eligibility Criteria

60 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Essentia Health SMDC Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stereotactic radiotherapy

Arm Description

Accelerated stereotactic radiotherapy as an adjuvant treatment for early stage breast cancer.

Outcomes

Primary Outcome Measures

To determine the feasibility of using CyberKnife radiotherapy to deliver partial breast radiotherapy for early stage breast cancer.
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 treated while also respecting normal tissue tolerances.

Secondary Outcome Measures

To determine if conformal irradiation to the operative bed using CyberKnife produces acceptable local control
Subjects will be followed for disease control following standard guidelines that include periodic PE and imaging with either mammography or screening breast MRaI for 5 years.

Full Information

First Posted
February 4, 2011
Last Updated
May 26, 2023
Sponsor
Essentia Health
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1. Study Identification

Unique Protocol Identification Number
NCT01290835
Brief Title
Conformal Partial Breast Irradiation With CyberKnife After Resection for Early Stage Breast Cancer
Acronym
CKPBI
Official Title
Conformal Partial Breast Irradiation With CyberKnife After Resection for Early Stage Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Essentia Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Stereotactic radiotherapy, CyberKnife following lumpectomy, Breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stereotactic radiotherapy
Arm Type
Experimental
Arm Description
Accelerated stereotactic radiotherapy as an adjuvant treatment for early stage breast cancer.
Intervention Type
Radiation
Intervention Name(s)
Stereotactic radiotherapy delivered by CyberKnife
Other Intervention Name(s)
CyberKnife
Intervention Description
Adjuvant radiotherapy will be delivered using CyberKnife radiotherapy using twice daily sessions for five days for a total of ten sessions.
Intervention Type
Radiation
Intervention Name(s)
stereotactic radiotherapy
Primary Outcome Measure Information:
Title
To determine the feasibility of using CyberKnife radiotherapy to deliver partial breast radiotherapy for early stage breast cancer.
Description
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 treated while also respecting normal tissue tolerances.
Time Frame
one year
Secondary Outcome Measure Information:
Title
To determine if conformal irradiation to the operative bed using CyberKnife produces acceptable local control
Description
Subjects will be followed for disease control following standard guidelines that include periodic PE and imaging with either mammography or screening breast MRaI for 5 years.
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of breast malignancy, stage T1 Surgical treatment with lumpectomy age 60 or older resection margins negative by at least 2mm any grade ER positive unicentric invasive ductal pathologic free of nodal metastases (N0, i- or i+) Post-lumpectomy cavity to whole breast ratio must be less than or equal to 30% Exclusion criteria Prior radiotherapy to the breast Neoadjuvant chemotherapy multicentric disease Pure DCIS histology Presence of extensive intraductal component Node positive disease (N1 or greater)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ken Dornfeld, MD
Organizational Affiliation
Essentia Health Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Essentia Health SMDC Cancer Center
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States

12. IPD Sharing Statement

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Conformal Partial Breast Irradiation With CyberKnife After Resection for Early Stage Breast Cancer

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