The goal of this study is to examine the role of Intraoperative Radiotherapy (IORT) in Ductal Carcinoma In-Situ (DCIS) and to improve the understanding of the clinical, radiographic, and patient-related impact of adopting IORT.
With advances in technology and screening, the overdiagnosis and overtreatment of ductal carcinoma in situ (DCIS) have increased. Minimizing treatment toxicity and cost is a high priority area of research. Intraoperative Radiation Therapy (IORT)is a form of radiation where a single high dose of irradiation is applied to the tumor bed at the time of lumpectomy. Its use has not been previously studied in DCIS. Proposed advantages include decreased toxicity to adjacent tissue and organs, reduction in healthcare costs, and improved quality of life. The investigators hypothesize that IORT is a safe and patient-friendly alternative to whole breast irradiation.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
265
Quality of Life questionnaires will be completed by each subject.
Columbia University Irving Medical Center
New York, New York, United States
Rate of local recurrence
Defined by ipsilateral breast tumor recurrence
Time frame: 5 years
Disease-free survival
Determine incidence of any distant or local recurrence after the breast-conserving surgery (BCS) and IORT
Time frame: 5 years
Overall survival
Quantify the overall survival in women with DCIS following BCS and IORT at 5 years.
Time frame: 5 years
Acute Toxicities associated with IORT
Quantify the frequency of acute toxicities that occur within 6 months of having BCS and IORT. Measured using physician and patient reported toxicity surveys.
Time frame: 6 months
Longterm radiation toxicity
Quantify the frequency of toxicities that occur at greater than 6 months after having BCS and IORT. Measured using using physician and patient reported toxicity surveys as well as photographic assessment of cosmetic outcome.
Time frame: 5 years
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