Locoregional Breast Cancer Recurrence Following Targeted Intraoperative Radiotherapy (IORT) for Ductal Carcinoma in Situ (DCIS)

STATUS

Recruiting
End date

Dec 20, 2027
participants needed

265
sponsor

Columbia University

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Updated on 20 October 2022

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carcinoma

carcinoma in situ

ductal carcinoma in situ

breast-conserving surgery

mammogram

ductal carcinoma

intraoperative radiation therapy

Summary

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.

Description

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.

Details

Condition	Breast Cancer, Ductal Carcinoma in Situ
Treatment	Quality of Life Questionnaires
Clinical Study Identifier	NCT03216421
Sponsor	Columbia University
Last Modified on	20 October 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Pathologically confirmed DCIS of the breast
	Clinical ≤ 3.0 cm unifocal lesion
	No clinical or pathological evidence of nodal involvement
	Operable DCIS, suitable for breast conserving surgery
	Plans to administer irradiation to the breast only
	Eastern Cooperative Oncology Group (ECOG) performance status of 0-3, however grade 4 patients may be enrolled at the discretion of the treating radiation oncologist
	Must have had a diagnostic mammogram or MRI performed within last 6 months
	Women of child-bearing potential must have a negative pregnancy test in accordance to institutional guidelines
	Women of child-bearing potential must agree to use adequate contraceptive precautions (defined as oral contraceptives, intrauterine devices, surgical contraceptives, or combination of condom and spermicide) from the time of negative pregnancy test through the radiation treatment period
	English or Spanish speaking
	Able to sign informed consent
	Amenable to regular follow-up (according to research policies) for at least 5 years
Exclusion Criteria
	Histologic or clinical evidence of invasive breast cancer
	Multicentric cancer in the ipsilateral breast as diagnosed by clinical examination, imaging, or pathologic assessment, not amenable to excision with negative margins with a single lumpectomy
	Synchronous bilateral breast cancer at the time of diagnosis
	Pathologic or imaging evidence of lymph node involvement
	Any severe concomitant disease that may limit their life expectancy to less than 5 years
	Prior history of breast cancer or in-field radiation in the ipsilateral breast
	Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
	Pregnant or breast feeding women

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Locoregional Breast Cancer Recurrence Following Targeted Intraoperative Radiotherapy (IORT) for Ductal Carcinoma in Situ (DCIS)