A Multi-Institutional Registry for CyberKnife Stereotactic Accelerated Partial Breast Irradiation (CK-SAPBI)
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|ClinicalTrials.gov Identifier: NCT02457117|
Recruitment Status : Unknown
Verified July 2019 by Georgetown University.
Recruitment status was: Recruiting
First Posted : May 29, 2015
Last Update Posted : July 17, 2019
|Condition or disease||Intervention/treatment|
|Breast Cancer||Radiation: CyberKnife Stereotactic Accelerated Partial Breast Irradiation (CK-SAPBI)|
Radiotherapy for breast cancer is delivered using several whole breast and partial breast approaches. The optimal approach is unknown. The utilization of partial breast irradiation is growing due to the convenience of fewer fractions versus fifteen- thirty treatments required with conventional or hypofractionated whole breast radiation therapy.
Early results with partial breast techniques are promising, showing similar cancer control and toxicity. There is a large body of mature Phase I/II and preliminary Phase III data available exploring the replacement of WBI with an accelerated course of radiation therapy restricted to the region around the tumor bed (accelerated Partial Breast Irradiation, aPBI) using a variety of techniques. For appropriately selected patients treated with modern techniques, the results are encouraging and the techniques have been shown to be safe, tolerable, and highly reproducible with outcomes similar to WBI.
Currently, there is limited data assessing the quality of life, cosmetic and oncologic outcomes following stereotactic partial breast irradiation in a large patient population. Our study will be the first essential step in aggregating the outcomes of patients undergoing this type of external beam irradiation in a large patient population.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||200 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||A Multi-Institutional Registry for CyberKnife Stereotactic Accelerated Partial Breast Irradiation (CK-SAPBI)|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
- Radiation: CyberKnife Stereotactic Accelerated Partial Breast Irradiation (CK-SAPBI)
Five fraction radiation therapy to the lumpectomy cavityOther Names:
- Breast SBRT
- partial breast irradiation
- In breast failure [ Time Frame: 5 years ]To evaluate the in-breast local failure (Ipsilateral breast events) and patterns of in-breast failure following CK-SAPBI
- Cosmesis [ Time Frame: 5 years ]Treatment related Cosmesis based on the Harvard Cosmesis Scale
- Regional Recurrence [ Time Frame: 5 years ]Regional recurrence free interval defined as time from end of radiation treatment to the diagnosis of disease in the regional lymph nodes
- Distant Recurrence [ Time Frame: 5 years ]Distant disease free interval defined as the time from end of radiation treatment to first diagnosis of distant disease, regardless of the occurrence of any intervening local or regional failure, contralateral breast cancer, or non-breast second primary cancer
- Adverse reactions [ Time Frame: 5 years ]Toxicity from treatment based on CTCAE version 4.0
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): NCT02457117
|Contact: Olusola Obayomi-Davies, M.D.||firstname.lastname@example.org|
|Contact: Michael Repka, M.D.||email@example.com|
|United States, District of Columbia|
|Georgetown University Hospital||Recruiting|
|Washington, District of Columbia, United States, 20008|
|Contact: Olusola OBAYOMI-DAVIES, M.D 202-444-3320 firstname.lastname@example.org|
|Principal Investigator: Olusola Obayomi-Davies, M.D|