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出境医 / 临床实验 / Cyberknife for Early Stage Breast Cancer

Cyberknife for Early Stage Breast Cancer

Study Description
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

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
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 30, 2014
Actual Study Completion Date : April 23, 2020
Arms and Interventions
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)

Outcome Measures
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. Score on The Harvard/NSABP/RTOG Breast Cosmesis Scale. [ Time Frame: Baseline, week 10, and week 26 ]
    4 Point Scale (I-IV): I. Excellent: When compared with the untreated breast, there is minimal or no difference in the size or shape of the treated breast. II. Good: There is a slight difference in the size or shape of the treated breast as compared with the opposite breast or the original appearance of the treated breast. There may be some mild reddening or darkening of the breast. The thickening or scar tissue III. Fair: Obvious difference in the size and shape of the treated breast. This change involves one-quarter or less of the breast. IV. Poor: Marked change in the appearance of the treated breast involving more than onequarter of the breast tissue. The skin changes may be obvious and detract from the appearance of the breast.

  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. The questions are divided into 5 categories-Material and Physical Well-being, Relationships with other People, Social, Community, and Civic Activities, Personal Development and Fulfillment and Recreation.The QOLS is scored by adding up the score on each item to yield a total score for the instrument. Scores can range from 16 to 112.


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

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.
Contacts and Locations

Locations
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United States, New York
NYU Langone Health
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
Layout table for investigator information
Principal Investigator: Jonathan A. Haas, MD NYU Winthrop Hospital
Tracking Information
First Submitted Date  ICMJE January 5, 2015
First Posted Date  ICMJE May 13, 2019
Last Update Posted Date February 18, 2021
Actual Study Start Date  ICMJE September 2010
Actual Primary Completion Date September 30, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
Local Control Rate [ Time Frame: 1 Year ]
Mastectomy-free survival rate after Cyberknife body radiosurgery [Mastectomy and death will be considered failures]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2020)
  • 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.
  • Score on The Harvard/NSABP/RTOG Breast Cosmesis Scale. [ Time Frame: Baseline, week 10, and week 26 ]
    4 Point Scale (I-IV): I. Excellent: When compared with the untreated breast, there is minimal or no difference in the size or shape of the treated breast. II. Good: There is a slight difference in the size or shape of the treated breast as compared with the opposite breast or the original appearance of the treated breast. There may be some mild reddening or darkening of the breast. The thickening or scar tissue III. Fair: Obvious difference in the size and shape of the treated breast. This change involves one-quarter or less of the breast. IV. Poor: Marked change in the appearance of the treated breast involving more than onequarter of the breast tissue. The skin changes may be obvious and detract from the appearance of the breast.
  • 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. The questions are divided into 5 categories-Material and Physical Well-being, Relationships with other People, Social, Community, and Civic Activities, Personal Development and Fulfillment and Recreation.The QOLS is scored by adding up the score on each item to yield a total score for the instrument. Scores can range from 16 to 112.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • 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.
  • Cosmesis [ Time Frame: 1 Year ]
    Cosmesis after Cyberknife body radiosurgery will be measured via Harvard Breast Cosmesis Scale.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cyberknife for Early Stage Breast Cancer
Official Title  ICMJE Cyberknife Radiosurgery for Early Stage Breast Cancer: A Winthrop-University Hospital Pilot Study of Cyberknife Partial Breast Radiosurgery for Tumors 3 cm or Less
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Early Stage Breast Cancer
Intervention  ICMJE 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)
Study Arms  ICMJE 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.
Intervention: Radiation: Cyberknife for Early Stage Breast Cancer
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 9, 2019)
26
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 23, 2020
Actual Primary Completion Date September 30, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 45 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03946683
Other Study ID Numbers  ICMJE 18-01721
18-01721 ( Other Identifier: NYU Langone Institutional Review Board )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jonathan A. Haas, MD NYU Winthrop Hospital
PRS Account NYU Langone Health
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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