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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

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

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My tumor is 3 cm or smaller.

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My breast cancer can be treated with a single surgery.

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My tumor can be removed with a lumpectomy.

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I do not have cancer in both breasts.

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I have multiple tumors in one breast, but only one is cancerous.

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I do not have any collagen vascular diseases.

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I have no health issues that would prevent me from having surgery.

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My breast cancer is confirmed to be invasive ductal carcinoma.

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My tumor is not attached to the skin, muscle, or chest wall.

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I am 48 years old or older.

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I can take care of myself and perform daily activities.

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My breast cancer does not have a large non-invasive part.

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I am female.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had chemotherapy for my current cancer.

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I have not had radiation therapy to my breast.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

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

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

~180

surgery

2005

Completed Phase 4

~7020

radiation therapy

1994

Completed Phase 3

~13390

0 / 15Eligibility criteria met

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor

359 Previous Clinical Trials

89,806 Total Patients Enrolled

52 Trials studying Breast Cancer

27,917 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 Sep 2025

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