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

Essentia Health

Status: Completed

Conditions: Breast Cancer

Treatments: Radiation: stereotactic radiotherapy; Radiation: Stereotactic radiotherapy delivered by CyberKnife

Study type: Interventional

Funder types: Other

Identifiers

NCT01290835

SMDC10101

Details and patient eligibility

About

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).

Full 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

Enrollment: 20 patients

Sex: Female

Ages: 60 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

Stereotactic radiotherapy

Experimental group

Description:

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

Treatment:

Radiation: stereotactic radiotherapy

Radiation: Stereotactic radiotherapy delivered by CyberKnife