Intensity Modulated Accelerated Partial Breast Irradiation Before Surgery in Treating Older Patients With Hormone Responsive Stage 0-I Breast Cancer
|Ductal Breast Carcinoma in Situ Estrogen Receptor-negative Breast Cancer Estrogen Receptor-positive Breast Cancer Invasive Ductal Breast Carcinoma Invasive Ductal Breast Carcinoma With Predominant Intraductal Component Lobular Breast Carcinoma in Situ Medullary Ductal Breast Carcinoma With Lymphocytic Infiltrate Mucinous Ductal Breast Carcinoma Papillary Ductal Breast Carcinoma Progesterone Receptor-positive Breast Cancer Stage IA Breast Cancer Stage IB Breast Cancer Tubular Ductal Breast Carcinoma||Radiation: accelerated partial breast irradiation Radiation: intensity-modulated radiation therapy Radiation: image-guided radiation therapy Procedure: therapeutic conventional surgery Other: questionnaire administration Other: laboratory biomarker analysis|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Feasibility of Assessing Radiation Response With MRI/CT Directed Preoperative Accelerated Partial Breast Irradiation in the Prone Position for Hormone Responsive Early Stage Breast Cancer|
- Reproducibility of the MRI directed pre-operative APBI treatment method based on meeting 3 criteria: acceptability of the definition of treatment targets by MRI, radiation virtual IMRT plans and completion of treatment (APBI and surgery) [ Time Frame: 4 weeks post-APBI ]The movement of the center of mass for each organ will be determined. Their means and the standard deviations will be calculated. Histogram will also be generated. The volumetric dosimetric parameters will be compared with historic data and will be used to search any correlation with follow-up outcome data.
- Acute surgical and radiotherapy toxicity as scored by the National Cancer Institute Common Toxicity Criteria (NCI CTCAE) version 4.0 [ Time Frame: Up to 4 weeks post-surgery ]
- Late surgical and radiotherapy toxicity as scored by the NCI CTCAE version 4.0 [ Time Frame: Up to 3 years ]
- Cosmetic outcome by the physician and patient [ Time Frame: At year 1 ]
- Cosmetic outcome by the physician and patient [ Time Frame: At year 3 ]
- In-breast recurrence [ Time Frame: Up to 3 years ]
- Regional recurrence [ Time Frame: Up to 3 years ]
- Distant metastases [ Time Frame: Up to 3 years ]
- Disease free survival [ Time Frame: Up to 3 years ]
- Overall survival [ Time Frame: Up to 3 years ]
|Study Start Date:||June 2015|
|Estimated Primary Completion Date:||October 2018 (Final data collection date for primary outcome measure)|
Experimental: Treatment (image-guided intensity-modulated APBI)
Patients undergo image-guided intensity-modulated APBI BID for 5 days over a period of 5-10 days for a total of 10 fractions. Within 4-6 weeks post-APBI, patients undergo lumpectomy.
Radiation: accelerated partial breast irradiation
Undergo image-guided intensity-modulated APBI
Other Name: APBIRadiation: intensity-modulated radiation therapy
Undergo image-guided intensity-modulated APBI
Other Name: IMRTRadiation: image-guided radiation therapy
Undergo image-guided intensity-modulated APBIProcedure: therapeutic conventional surgery
Undergo lumpectomyOther: questionnaire administration
Ancillary studiesOther: laboratory biomarker analysis
I. Establish the feasibility for preoperative APBI delivered with intensity-modulated radiation therapy (IMRT) in the prone position using daily computed tomography (CT) guidance for stage 0-I breast cancer patients who are intended to undergo a lumpectomy for breast conserving therapy.
I. To determine the acute and late surgical and radiation toxicity of preoperative APBI delivered with IMRT in the prone position.
II. To document the cosmetic appearance of the breast when treated with preoperative APBI IMRT in the prone position.
III. Establish the percentage of patients that can meet dosimetric goals and normal tissue constraints if treated with preoperative APBI IMRT in the prone position.
Patients undergo image-guided intensity-modulated APBI twice daily (BID) for 5 days over a period of 5-10 days for a total of 10 fractions. Within 4-6 weeks post-APBI, patients undergo lumpectomy.
After completion of treatment, patients are followed up at 4 weeks and then at 1, 2, and 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02186470
|Contact: Ohio State University Comprehensive Cancer Center||1-800-293-5066||Jamesline@osumc.edu|
|United States, Ohio|
|Ohio State University Comprehensive Cancer Center||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Julia R. White, MD 614-688-7367 Julia.White@osumc.edu|
|Principal Investigator: Julia R. White, MD|
|Principal Investigator:||Julia White, MD||Ohio State University Comprehensive Cancer Center|