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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
NRR Trial 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.Check my eligibility
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.See study design
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.
NRR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
NRR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
Association of Nuclear Factor Kappa-light-chain-enhancer of Activated B Cells (NFkB) Expression in Tumor and Normal Tissue Before and After IORT
Association of Nuclear p53 Expression in Tumor and Normal Tissue Before and After IORT
Body tissue
NRR 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
~6010
radiation therapy
1994
Completed Phase 3
~13390
Find a Location
Who is running the clinical trial?
UNC Lineberger Comprehensive Cancer CenterLead Sponsor
351 Previous Clinical Trials
88,243 Total Patients Enrolled
51 Trials studying Breast Cancer
27,897 Patients Enrolled for Breast Cancer
David Olilla, MDPrincipal InvestigatorUNC Lineberger Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had chemotherapy for my current cancer.My tumor is 3 cm or smaller.My breast cancer can be treated with a single surgery.My tumor can be removed with a lumpectomy.I do not have cancer in both breasts.My breast cancer is confirmed to be invasive ductal carcinoma.I had cancer before, but it was treated, hasn't returned in 5 years, and is unlikely to come back.I have multiple tumors in one breast, but only one is cancerous.I do not have any collagen vascular diseases.My tumor is not attached to the skin, muscle, or chest wall.I am 48 years old or older.I can take care of myself and perform daily activities.My breast cancer does not have a large non-invasive part.My doctors agree I can have surgery to remove my breast cancer without removing the entire breast.I have no health issues that would prevent me from having surgery.I have not had radiation therapy to my breast.Not applicable.I am female.
Research Study Groups:
This trial has the following groups:- Group 1: Intraoperative Radiation Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the research team currently looking to enroll more participants?
"As shown on clinicaltrials.gov, this trial is no longer open for recruitment - it was initially posted on March 18th 2003 and last updated December 20th 2021. However, there are over 2600 other studies requiring participants currently available to join."
Answered by AI
Is the age threshold for inclusion in this research limited to those younger than 35?
"This clinical trial seeks participants that are between 48 and 120 years of age."
Answered by AI
Is it possible for me to be enrolled in this clinical experiment?
"Individuals with a diagnosis of breast cancer, aged between 48 and 120 years old, may be eligible for this clinical trial. It is currently looking to enrol 89 participants in total."
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