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Radiation Therapy

Intraoperative Radiotherapy for Breast Cancer

N/A
Waitlist Available
Led By Eileen Connolly, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Plans to administer irradiation to the breast only
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
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will look at using Intraoperative Radiotherapy (IORT) to treat Ductal Carcinoma In-Situ (DCIS). Researchers want to learn more about how well it works and what effects it has on patients.

Who is the study for?
This trial is for women with a specific breast condition called DCIS, who are fit enough for surgery and radiation (ECOG 0-3), have no invasive cancer or multiple tumors in one breast, no lymph node involvement, and not pregnant. They must be able to follow up for 5 years and use birth control if of childbearing age.
What is being tested?
The study tests Intraoperative Radiotherapy (IORT) as a treatment option for Ductal Carcinoma In-Situ (DCIS) of the breast. It aims to understand its effects on clinical outcomes, imaging results, and patient quality of life through questionnaires.
What are the potential side effects?
While the trial focuses on IORT's effectiveness and impact rather than side effects, typical risks may include skin irritation, fatigue, pain or discomfort at the treatment site. Quality of Life Questionnaires assess personal experiences.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for radiation therapy to my breast only.
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I agree to use effective birth control during the study.
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My breast cancer is diagnosed as DCIS.
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My breast cancer is at an early stage and can be removed with surgery.
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My cancer is in one spot and is 3 cm or smaller.
Select...
My cancer has not spread to my lymph nodes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with invasive breast cancer.
Select...
I have multiple tumors in one breast that cannot be removed with a single surgery.
Select...
I was diagnosed with cancer in both breasts at the same time.
Select...
I do not have any severe illness that would limit my life to under 5 years.
Select...
I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
Select...
My cancer has spread to my lymph nodes.
Select...
I have had breast cancer or radiation in the same breast before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of local recurrence
Secondary study objectives
Acute Coryza
Disease
Longterm radiation toxicity
+1 more

Side effects data

From 2008 Phase 4 trial • 314 Patients • NCT00734097
5%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Esomeprazole 40mg, Daily

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Low/Intermediate Grade DCISExperimental Treatment1 Intervention
Subjects with Low/Intermediate Grade DCIS will complete quality of life questionnaires before and after the IORT.
Group II: High Grade DCISExperimental Treatment1 Intervention
Subjects with High Grade DCIS will complete quality of life questionnaires before and after the IORT.

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,486 Previous Clinical Trials
2,662,915 Total Patients Enrolled
29 Trials studying Breast Cancer
23,389 Patients Enrolled for Breast Cancer
Eileen Connolly, MDPrincipal Investigator - Assistant Professor of Radiation Oncology
Columbia Presbyterian Radiologists, New York Presbyterian Hospital-Columbia Presbyterian Center
New York University School Of Medicine (Medical School)
2 Previous Clinical Trials
45 Total Patients Enrolled

Media Library

IORT (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03216421 — N/A
Breast Cancer Research Study Groups: High Grade DCIS, Low/Intermediate Grade DCIS
Breast Cancer Clinical Trial 2023: IORT Highlights & Side Effects. Trial Name: NCT03216421 — N/A
IORT (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03216421 — N/A
~72 spots leftby Aug 2027
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