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| ID | Type | Description | Link |
|---|---|---|---|
| 18-01721 | Other Identifier | NYU Langone Institutional Review Board |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyberknife for Early Stage Breast Cancer | Experimental | Cyberknife Robotic Radiosurgery will be utilized as a 5-fraction post-lumpectomy adjuvant radiation treatment in the management of early stage breast cancer. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyberknife for Early Stage Breast Cancer | Radiation | Utilization of Cyberknife Robotic Radiosurgery as a 5-fraction post-lumpectomy adjuvant radiation treatment in the management of early stage breast cancer |
| Measure | Description | Time Frame |
|---|---|---|
| Local Control Rate | Mastectomy-free survival rate after Cyberknife body radiosurgery [Mastectomy and death will be considered failures] | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Complication Rate | 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. | 1 Year |
| Score on The Harvard/NSABP/RTOG Breast Cosmesis Scale. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan A. Haas, MD | NYU Winthrop Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
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| Label | URL |
|---|---|
| CyberKnife Radiosurgery for Early-Stage Breast Cancer | View source |
| University of Texas Southwestern launches clinical trial for treatment of breast cancer using robotic CyberKnife technology | View source |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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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. |
| Baseline, week 10, and week 26 |
| Measure of self reported quality of life using the QOLS | 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. | 1 Year |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |