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Pilot Study of Cyberknife for Early Stage Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03946683
Recruitment Status : Active, not recruiting
First Posted : May 13, 2019
Last Update Posted : May 13, 2019
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:

This phase II study based on the Cyberknife Society study will evaluate the technical feasibility and acute toxicity of Partial Breast Irradiation (PBI) with the Cyberknife. It will evaluate quality of life (QOL) issues as they relate to treatment-related side effects, cosmetic result and patient convenience. It will evaluate outcome in terms of local control in the treated breast.

Radiosurgery is defined as the stereotactic delivery of ionizing radiation in 5 stages or less to a designated target with sub-millimeter accuracy. Radiosurgery in the context of this protocol will be given to the region of the tumor bed with 7 weeks of the lumpectomy and sent/axillary node sampling over the period of five to ten days using the Cyberknife (CK) or within the 7 weeks of the last chemotherapy treatment if given.

Condition or disease Intervention/treatment Phase
Early Stage Breast Cancer Radiation: Cyberknife for Early Stage Breast Cancer Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cyberknife Radiosurgery for Early Stage Breast Cancer: A Winthrop-University Hospital Pilot Study of Cyberknife Partial Breast Radiosurgery for Tumors 3 cm or Less
Actual Study Start Date : September 2010
Actual Primary Completion Date : September 2014
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Cyberknife for Early Stage Breast Cancer
Cyberknife Robotic Radiosurgery will be utilized as a 5-fraction post-lumpectomy adjuvant radiation treatment in the management of early stage breast cancer.
Radiation: Cyberknife for Early Stage Breast Cancer
Utilization of Cyberknife Robotic Radiosurgery as a 5-fraction post-lumpectomy adjuvant radiation treatment in the management of early stage breast cancer
Other Name: SBRT (Stereotactic Body Radiation Therapy)

Primary Outcome Measures :
  1. Local Control Rate [ Time Frame: 1 Year ]
    Mastectomy-free survival rate after Cyberknife body radiosurgery [Mastectomy and death will be considered failures]

Secondary Outcome Measures :
  1. Complication Rate [ Time Frame: 1 Year ]
    Rate of complications or toxicities after Cyberknife body radiosurgery (including skin reactions to radiotherapy and any acute complications or unusual side effects) will be measured via physician's observation and via toxicity reports.

  2. Cosmesis [ Time Frame: 1 Year ]
    Cosmesis after Cyberknife body radiosurgery will be measured via Harvard Breast Cosmesis Scale.

  3. Measure of self reported quality of life using the QOLS [ Time Frame: 1 Year ]
    41-item survey can be administered by interviewed in person or over the telephone, and it may also be self-administered by respondents with adequate cognitive functioning.

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with stage 0, I, or II (Tis, Ti, or T2 <=3cm & NO) histologically confirmed invasive non-lobular carcinoma or ductal carcinoma in situ of the breast with a lesion <= 3 cm, treated with wide excision.
  • Negative inked histologic margins of excision or reexcision and clear of invasive tumor and DClS by at least 2mm
  • Negative post-excision or post-reexcision mammography if cancer presented with malignancy-associated microcalcifications; no remaining suspicious microcalcifications in the breast before radiotherapy.
  • No involved axillary lymph nodes by routine histologic examination (H&E) of sentinel node(s) or of nodes identified from axillary dissection.
  • Enrollment and initiation of CyberKnife therapy within 42 days of last breast cancer surgery or last chemotherapy treatment.

Exclusion Criteria:

  • Patients with invasive lobular carcinoma or nonepithelial breast malignancies such as sarcoma or lymphoma.
  • 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.
  • Patients who are pregnant.
  • Patients who have any histologically confirmed positive axillary nodes.
  • Patients with collagen vascular diseases, specifically systemic lupus erythematosis, scleroderma, or dermatomyositis with a creatine phosphokinase level above normal or with an active skin rash.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03946683

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United States, New York
NYU Langone Health
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
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Principal Investigator: Jonathan A. Haas, MD NYU Winthrop Hospital

Additional Information:
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Responsible Party: NYU Langone Health Identifier: NCT03946683     History of Changes
Other Study ID Numbers: 18-01721
18-01721 ( Other Identifier: NYU Langone Institutional Review Board )
First Posted: May 13, 2019    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases