Pilot Study of Cyberknife for Early Stage Breast Cancer
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|ClinicalTrials.gov Identifier: NCT03946683|
Recruitment Status : Active, not recruiting
First Posted : May 13, 2019
Last Update Posted : May 13, 2019
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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)
- Local Control Rate [ Time Frame: 1 Year ]Mastectomy-free survival rate after Cyberknife body radiosurgery [Mastectomy and death will be considered failures]
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT03946683
|United States, New York|
|NYU Langone Health|
|New York, New York, United States, 10016|
|Principal Investigator:||Jonathan A. Haas, MD||NYU Winthrop Hospital|