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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

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

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

NCT ID

NCT03216421

First Posted

July 11, 2017

Last Updated

October 10, 2022

Sponsor

Columbia University

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

Studies a U.S. FDA-regulated Device Product

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

Time Frame

5 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

epc2116@cumc.columbia.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Mariamne Reyna

Phone

646-317-4244

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

epc2116@cumc.columbia.edu

First Name & Middle Initial & Last Name & Degree

Mariamne Reyna

Phone

646-317-4244

mo2213@cumc.columbia.edu

12. IPD Sharing Statement

Plan to Share IPD

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Intraoperative Radiation Therapy (IORT) in DCIS

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