Intraoperative Radiation Therapy (IORT) in DCIS

NCT03216421 | Active Not Recruiting DMC

• 1 other identifier: AAAQ7853
• Study Type: interventional
• Target: 265
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Ductal Carcinoma in Situ

Keywords

DCIS; Intraoperative Radiation (IORT); Lumpectomy; Breast Conserving Surgery

Outcome Measures

Primary Outcomes (1)

• Rate of local recurrence

  Defined by ipsilateral breast tumor recurrence

  5 years

Secondary Outcomes (4)

• Disease-free survival

  5 years

• Overall survival

  5 years

• Acute Toxicities associated with IORT

  6 months

• Longterm radiation toxicity

  5 years

Study Arms (2)

Low/Intermediate Grade DCIS

OTHER

Subjects with Low/Intermediate Grade DCIS will complete quality of life questionnaires before and after the IORT.

Other: Quality of Life Questionnaires

High Grade DCIS

OTHER

Subjects with High Grade DCIS will complete quality of life questionnaires before and after the IORT.

Other: Quality of Life Questionnaires

Interventions

Quality of Life Questionnaires OTHER

Quality of Life questionnaires will be completed by each subject.

High Grade DCIS; Low/Intermediate Grade DCIS

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Study Officials

• Eileen Connolly, MD

  Assistant Professor of Radiation Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 11, 2017
• First Posted: July 13, 2017
• Study Start: September 12, 2017
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)