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

Essentia Health20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

Stereotactic radiotherapy delivered by CyberKnifeRADIATION

Adjuvant radiotherapy will be delivered using CyberKnife radiotherapy using twice daily sessions for five days for a total of ten sessions.

stereotactic radiotherapyRADIATION

Eligibility

Sex: FEMALEMin age: 60 YearsMax age: 60 Years

Medical Language ↔ Plain English

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)

Locations (1)

Essentia Health SMDC Cancer Center

Duluth, Minnesota, United States

Outcomes

Primary Outcomes

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.

Time frame: one year

Secondary Outcomes

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.

Time frame: 1 year

Data from ClinicalTrials.gov

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