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Intraoperative Radiation Therapy (IORT) in DCIS

Primary Purpose

Breast Cancer, Ductal Carcinoma in Situ

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Quality of Life Questionnaires
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring DCIS, Intraoperative Radiation (IORT), Lumpectomy, Breast Conserving Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Columbia University Irving Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Low/Intermediate Grade DCIS

High Grade DCIS

Arm Description

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

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

Outcomes

Primary Outcome Measures

Rate of local recurrence
Defined by ipsilateral breast tumor recurrence

Secondary Outcome Measures

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

Full Information

First Posted
July 11, 2017
Last Updated
October 10, 2022
Sponsor
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT03216421
Brief Title
Intraoperative Radiation Therapy (IORT) in DCIS
Official Title
Locoregional Breast Cancer Recurrence Following Targeted Intraoperative Radiotherapy (IORT) for Ductal Carcinoma in Situ (DCIS)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 12, 2017 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Ductal Carcinoma in Situ
Keywords
DCIS, Intraoperative Radiation (IORT), Lumpectomy, Breast Conserving Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
265 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low/Intermediate Grade DCIS
Arm Type
Other
Arm Description
Subjects with Low/Intermediate Grade DCIS will complete quality of life questionnaires before and after the IORT.
Arm Title
High Grade DCIS
Arm Type
Other
Arm Description
Subjects with High Grade DCIS will complete quality of life questionnaires before and after the IORT.
Intervention Type
Other
Intervention Name(s)
Quality of Life Questionnaires
Intervention Description
Quality of Life questionnaires will be completed by each subject.
Primary Outcome Measure Information:
Title
Rate of local recurrence
Description
Defined by ipsilateral breast tumor recurrence
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Disease-free survival
Description
Determine incidence of any distant or local recurrence after the breast-conserving surgery (BCS) and IORT
Time Frame
5 years
Title
Overall survival
Description
Quantify the overall survival in women with DCIS following BCS and IORT at 5 years.
Time Frame
5 years
Title
Acute Toxicities associated with IORT
Description
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
Title
Longterm radiation toxicity
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eileen Connolly, MD
Phone
212-305-5050
Email
epc2116@cumc.columbia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mariamne Reyna
Phone
646-317-4244
Email
mo2213@cumc.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eileen Connolly, MD
Organizational Affiliation
Assistant Professor of Radiation Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eileen Connolly, MD
Phone
212-305-5050
Email
epc2116@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Mariamne Reyna
Phone
646-317-4244
Email
mo2213@cumc.columbia.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Intraoperative Radiation Therapy (IORT) in DCIS

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