Clinical trial NCT01290835: Conformal Partial Breast Irradiation With CyberKnife After Resection for Early Stage Breast Cancer
Official title: Conformal Partial Breast Irradiation With CyberKnife After Resection for Early Stage Breast Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Stereotactic radiotherapy
CyberKnife following lumpectomy
Breast cancer
Lead sponsor: Essentia Health
Sponsor class: OTHER
First posted: 2011-02-07
Enrollment: 20
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility 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)

Primary outcomes:
measure: To determine the feasibility of using CyberKnife radiotherapy to deliver partial breast radiotherapy for early stage breast cancer.
timeFrame: one year
Secondary outcomes:
measure: To determine if conformal irradiation to the operative bed using CyberKnife produces acceptable local control
timeFrame: 1 year
Other outcomes:
Locations:
city: Duluth
country: United States
facility: Essentia Health SMDC Cancer Center
state: Minnesota
Study officials:
affiliation: Essentia Health Oncology
name: Ken Dornfeld, MD
role: PRINCIPAL_INVESTIGATOR
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