NCT03216421

Intraoperative Radiation Therapy (IORT) in DCIS

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 265 (estimated)
• Sponsor: Columbia University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Breast Cancer
• Ductal Carcinoma in Situ

Interventions

Type	Name	Description
OTHER	Quality of Life Questionnaires	Quality of Life questionnaires will be completed by each subject.

Timeline

• Start date: 2017-09-12
• Primary completion: 2027-08-01
• Completion: 2029-12-31
• First posted: 2017-07-13
• Last updated: 2025-08-19

Locations

1 site across 1 country: United States