Intraoperative Radiation Therapy (IORT) in DCIS

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Ductal Carcinoma in Situ
• Intervention / Treatment: Other: Quality of Life Questionnaires

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.

• Study Type: Interventional
• Enrollment (Anticipated): 265
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Irving Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Low/Intermediate Grade DCIS; Subjects with Low/Intermediate Grade DCIS will complete quality of life questionnaires before and after the IORT.	Other: Quality of Life Questionnaires; Quality of Life questionnaires will be completed by each subject.
Other: High Grade DCIS; Subjects with High Grade DCIS will complete quality of life questionnaires before and after the IORT.	Other: Quality of Life Questionnaires; Quality of Life questionnaires will be completed by each subject.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of local recurrence	Defined by ipsilateral breast tumor recurrence	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free survival	Determine incidence of any distant or local recurrence after the breast-conserving surgery (BCS) and IORT	5 years
Overall survival	Quantify the overall survival in women with DCIS following BCS and IORT at 5 years.	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.	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.	5 years

Collaborators and Investigators

• Sponsor: Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2017
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2027

Study Registration Dates

• First Submitted: July 11, 2017
• First Submitted That Met QC Criteria: July 11, 2017
• First Posted (Actual): July 13, 2017

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 10, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Breast Conserving Surgery; DCIS; Lumpectomy; Intraoperative Radiation (IORT)
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Breast Diseases; Neoplasms, Ductal, Lobular, and Medullary; Breast Carcinoma In Situ; Carcinoma in Situ; Breast Neoplasms; Carcinoma; Carcinoma, Ductal; Carcinoma, Intraductal, Noninfiltrating
• Other Study ID Numbers: AAAQ7853

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No