Conformal Partial Breast Irradiation With CyberKnife After Resection for Early Stage Breast Cancer (CKPBI)
|ClinicalTrials.gov Identifier: NCT01290835|
Recruitment Status : Active, not recruiting
First Posted : February 7, 2011
Last Update Posted : October 5, 2016
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Radiation: Stereotactic radiotherapy delivered by CyberKnife Radiation: stereotactic radiotherapy||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Conformal Partial Breast Irradiation With CyberKnife After Resection for Early Stage Breast Cancer|
|Study Start Date :||June 2010|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||August 2020|
Experimental: Stereotactic radiotherapy
Accelerated stereotactic radiotherapy as an adjuvant treatment for early stage breast cancer.
Radiation: Stereotactic radiotherapy delivered by CyberKnife
Adjuvant radiotherapy will be delivered using CyberKnife radiotherapy using twice daily sessions for five days for a total of ten sessions.
Other Name: CyberKnifeRadiation: stereotactic radiotherapy
- To determine the feasibility of using CyberKnife radiotherapy to deliver partial breast radiotherapy for early stage breast cancer. [ Time Frame: one year ]Subjects will undergo a treatment plan for partial breast irradiation with cyberknife. Feasibility will be determined by monitoring the number of potential eligible subjects enrolled that can be treated while also respecting normal tissue tolerances.
- To determine if conformal irradiation to the operative bed using CyberKnife produces acceptable local control [ Time Frame: 1 year ]Subjects will be followed for disease control following standard guidelines that include periodic PE and imaging with either mammography or screening breast MRaI for 5 years.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01290835
|United States, Minnesota|
|Essentia Health SMDC Cancer Center|
|Duluth, Minnesota, United States, 55805|
|Principal Investigator:||Ken Dornfeld, MD||Essentia Health Oncology|