Clinical Trials /

CyberKnife Stereotactic Accelerated Partial Breast Irradiation (SAPBI)

NCT02365714

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Terminated

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: CyberKnife Stereotactic Accelerated Partial Breast Irradiation (SAPBI)
  • Official Title: A Pilot Study of Stereotactic Accelerated Partial Breast Irradiation (SAPBI) for Post-Menopausal Women (>50 y/o) With Ductal Carcinoma in Situ (DCIS) or Early Stage Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: CRC012015-02
  • NCT ID: NCT02365714

Conditions

  • Breast Cancer
  • DCIS
  • Invasive Ductal Carcinoma

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Treatment-RadiationOtherCyberKnife (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.

    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
          
    Maximum Eligible Age:99 Years
    Minimum Eligible Age:50 Years
    Eligible Gender:Female
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:The primary endpoint for this study is the percentage of enrolled subjects in whom CyberKnife SAPBI PBI is technically feasible to deliver and complete treatment
    Time Frame:Enrollment to 24 months
    Safety Issue:
    Description:

    Secondary Outcome Measures

    Measure:Ipsilateral breast recurrence
    Time Frame:1 month post radiation treatment through 5 years post treatment
    Safety Issue:
    Description:

    Details

    Phase:Phase 1/Phase 2
    Primary Purpose:Interventional
    Overall Status:Terminated
    Lead Sponsor:Georgetown University

    Last Updated

    January 17, 2017