← Back to Search

Intraoperative Radiation Therapy for Breast Cancer (NRR Trial)

N/A
Waitlist Available
Led By David Olilla, MD
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Tumor size ≤ 3 cm
No clinical or radiographic multifocal disease not amenable to single segmental mastectomy
Must not have
No prior chemotherapy for this malignancy
No prior radiotherapy to the breast
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying radiation therapy during surgery for older women with invasive breast cancer.

Who is the study for?
This trial is for women aged 48 and over with invasive ductal carcinoma of the breast, suitable for breast-conserving surgery. They should be able to undergo surgery without medical issues, have a life expectancy of at least 5 years, not be pregnant, and use effective contraception if fertile. Prior malignancies are okay if there's no recurrence risk.
What is being tested?
The study is examining the effectiveness of radiation therapy administered during surgery in older women with invasive breast cancer. It aims to see how well this approach works as part of their treatment plan.
What are the potential side effects?
Radiation therapy can cause side effects such as skin irritation at the treatment site, fatigue, mild swelling or heaviness in the treated breast, changes in skin texture or coloration, and rarely more serious complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My tumor is 3 cm or smaller.
Select...
My breast cancer can be treated with a single surgery.
Select...
My tumor can be removed with a lumpectomy.
Select...
I do not have cancer in both breasts.
Select...
I have multiple tumors in one breast, but only one is cancerous.
Select...
I do not have any collagen vascular diseases.
Select...
I have no health issues that would prevent me from having surgery.
Select...
My breast cancer is confirmed to be invasive ductal carcinoma.
Select...
My tumor is not attached to the skin, muscle, or chest wall.
Select...
I am 48 years old or older.
Select...
I can take care of myself and perform daily activities.
Select...
My breast cancer does not have a large non-invasive part.
Select...
I am female.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not had chemotherapy for my current cancer.
Select...
I have not had radiation therapy to my breast.

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
Incidence of Grade 3/4 Toxicity
Ipsilateral Breast Recurrence
Rates of Good/Excellent Cosmesis as Measured by the Radiation Therapy Oncology Group (RTOG) Cosmetic Rating Scale - Rated by Patients
+1 more

Awards & Highlights

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Intraoperative Radiation ArmExperimental Treatment3 Interventions
Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
therapy
2016
N/A
~270
surgery
2005
Completed Phase 4
~7080
radiation therapy
1994
Completed Phase 3
~13390

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor
365 Previous Clinical Trials
92,631 Total Patients Enrolled
52 Trials studying Breast Cancer
28,017 Patients Enrolled for Breast Cancer
David Olilla, MDPrincipal InvestigatorUNC Lineberger Comprehensive Cancer Center

Media Library

therapy Clinical Trial Eligibility Overview. Trial Name: NCT00182728 — N/A
Breast Cancer Research Study Groups: Intraoperative Radiation Arm
Breast Cancer Clinical Trial 2023: therapy Highlights & Side Effects. Trial Name: NCT00182728 — N/A
therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT00182728 — N/A
~4 spots leftby Jan 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top