CyberKnife Stereotactic Accelerated Partial Breast Irradiation (SAPBI)

NCT ID: NCT02365714

Last Updated: 2018-04-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2017-01-31

Brief Summary

This study will prospectively evaluate the technical feasibility, acute toxicity, late effects and oncologic outcomes of CyberKnife Stereotactic Accelerated Partial Breast Irradiation (CK-SAPBI) in early stage breast cancer. It will evaluate quality of life (QOL) issues as they relate to treatment-related side effects and cosmetic results.

Detailed Description

This study will determine the feasibility, acute and late toxicity as well as oncologic outcomes following CK-SAPBI.

Conditions

Breast Cancer; DCIS; Invasive Ductal Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment-Radiation

CyberKnife (CK) Stereotactic Accelerated Partial Breast Irradiation. Adjuvant radiation therapy delivered to the region around the lumpectomy cavity. Patients will receive 30 Gy in 5 fractions over 5-14 days.

Group Type: OTHER

CK Stereotactic Accelerated Partial Breast Irradiation

Intervention Type: RADIATION

Adjuvant radiation therapy will be delivered to the region of the lumpectomy cavity once daily for 5 treatments over 5-10 days.

Interventions

CK Stereotactic Accelerated Partial Breast Irradiation

Adjuvant radiation therapy will be delivered to the region of the lumpectomy cavity once daily for 5 treatments over 5-10 days.

Intervention Type: RADIATION

Other Intervention Names

CyberKnife, SAPBI

Eligibility Criteria

Inclusion Criteria

• -Newly diagnosed Stage 0 or I breast cancer.
• On histological examination, the tumor must be DCIS or invasive non-lobular carcinoma of the breast
• Surgical treatment of the breast must have been wide excision, lumpectomy or partial mastectomy
• Age 50 years or greater
• ER positive: (≥1% of breast tumor cells express ER in their nuclei)
• PR (progesterone receptor) positive: (≥ 1% of breast tumor cells express PR in their nuclei)
• Her2 negative (IHC 0-1+; for IHC 2+, FISH (fluorescence in situ hybridization) must be non-amplified)
• Subjects with invasive tumors should undergo axillary sentinel lymph node evaluation or axillary lymph node dissection.
• Negative inked surgical margins of excision or re-excision, clear of invasive tumor (no cells on ink) and DCIS by at least 1 mm
• Negative post-excision or post-reexcision mammography if cancer presented with malignancy-associated microcalcifications with no remaining suspicious calcifications in the breast before radiotherapy. Alternatively, a specimen radiograph can be obtained showing all the suspicious calcifications.
• No involved axillary lymph nodes, N0(i+) allowed
• Enrollment and the plan to initiate of CyberKnife therapy within 12 weeks of the last breast cancer surgery.
• Target lumpectomy cavity/whole breast reference volume must be <30% based on treatment planning CT
• Signed study-specific informed consent form

Exclusion Criteria

• -Patients with invasive lobular carcinoma or nonepithelial breast malignancies such as sarcoma or lymphoma.
• Patients with tumors greater than 2 cm
• Patients with surgical margins which cannot be microscopically assessed or not cleared by at least 2mm at pathological evaluation.
• Patients with multicentric carcinoma or with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy. Breast MRI will be recommended to exclude multicentric disease and additional suspicious areas will require biopsy to exclude malignancy.
• Patient with lymphovascular space invasion (LVSI).
• Patients with involved axillary nodes.
• Patients with collagen vascular diseases.
• Patient with known deleterious BRCA1/2 mutations or known mutations in other high penetrance genes (TP53, STK11, PTEN-phosphatase and tensin homolog, CDH1)
• Patients with prior ipsilateral breast irradiation.
• Patients with prior ipsilateral thoracic irradiation.
• Patients with Paget's disease of the nipple.
• Patients with diffuse suspicious microcalcifications.
• Patients with suspicious microcalcifications remaining on the post-excision mammogram.
• Patients receiving (neo)adjuvant systemic therapy other than hormonal therapy
• Patients with oncoplastic reconstruction and absence of surgical clips

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Georgetown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sonali Rudra, M.D.

Role: PRINCIPAL_INVESTIGATOR

Georgetown University Hospital

Locations

Georgetown University Hospital

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

CRC012015-02

Identifier Type: -

Identifier Source: org_study_id