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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: Stereotactic radiotherapy delivered by CyberKnife
* Radiation: stereotactic radiotherapy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stereotactic radiotherapy<br>Accelerated stereotactic radiotherapy as an adjuvant treatment for early stage breast cancer. | Radiation: Stereotactic radiotherapy delivered by CyberKnife<br>* Adjuvant radiotherapy will be delivered using CyberKnife radiotherapy using twice daily sessions for five days for a total of ten sessions.<br>* Other names: CyberKnife;Radiation: stereotactic radiotherapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stereotactic radiotherapy, CyberKnife following lumpectomy, Breast cancer