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Surgery vs Pre-Surgery Radiotherapy for Breast Cancer (NORDIS Trial)
N/A
Recruiting
Led By Irene Wapnir, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Mammographic or MRI non-mass lesion (calcifications, non-mass enhancement on MRI) measuring 4 cm or less in greatest dimension
ECOG performance status 0, 1, or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
NORDIS Trial Summary
This trial is comparing two methods for treating ductal carcinoma in situ, or DCIS. One method is surgery to remove the DCIS, and the other is neoadjuvant radiotherapy, or radiation therapy before surgery.
Who is the study for?
This trial is for individuals with non-palpable, image-detected ductal carcinoma in situ (DCIS) of the breast measuring up to 4 cm. Participants must have a biopsy marker placed and an ECOG performance status of 0-2. Prior contralateral breast cancer is okay, but not ipsilateral cancer or multicentric/multifocal DCIS, Paget's disease, invasive carcinoma on biopsy, mass lesions/palpable tumors over 4 cm, or positive lymph nodes.Check my eligibility
What is being tested?
The study compares immediate surgical removal (lumpectomy) versus radiation therapy followed by delayed surgery for treating DCIS. The goal is to assess which method is more effective based on pathological findings from the excised tissue.See study design
What are the potential side effects?
Potential side effects include skin changes like redness and irritation from radiation therapy; pain, swelling, infection risk at the surgery site; fatigue from both treatments; and possible scarring or changes in breast shape.
NORDIS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast scan shows a non-mass lesion 4 cm or smaller.
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I can take care of myself and perform daily activities.
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I had cancer in the opposite breast before.
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My breast cancer was found by imaging, not by feeling it, and confirmed with a needle biopsy.
NORDIS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of ductal carcinoma in situ (DCIS) pathologic complete response
Secondary outcome measures
Correlation of ductal carcinoma in situ (DCIS) subtypes with rate of DCIS pathologic complete response to neoadjuvant partial breast irradiation (PBI)
Correlation of post-radiation imaging characteristics with pathologic findings
Nuclear atypia comparison of radiation-induced treatment effect pathologically pre- versus post-therapy
+5 moreNORDIS Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Neoadjuvant partial breast irradiationExperimental Treatment2 Interventions
Partial breast irradiation will be delivered once a day for 5 days before surgery. The planned daily dose is 6 Gy.
Group II: Surgical ExcisionActive Control1 Intervention
Surgical excision of ductal carcinoma
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lumpectomy
2008
N/A
~670
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,393 Previous Clinical Trials
17,341,266 Total Patients Enrolled
Irene Wapnir, MDPrincipal InvestigatorStanford University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My breast scan shows a non-mass lesion 4 cm or smaller.I can take care of myself and perform daily activities.I have no remaining signs of the lesion after my biopsy.I may have abnormal cells or lobular carcinoma in either breast.I had cancer in the opposite breast before.My breast cancer is larger than 4 cm on imaging tests.A specialist confirmed that less than 30% of my breast will be affected by radiation.I may or may not have a marker placed in my tumor area to guide surgery.You have been diagnosed with invasive cancer using a core needle biopsy.I have a marker in my tumor confirmed by recent imaging showing remaining abnormality.I have had breast cancer before in the same breast.My breast cancer's hormone receptor status can be any type.My breast cancer is in more than one location.I have Paget's disease of the breast.I have an active connective tissue disease.I have cancer in both breasts at the same time.My cancer has spread to the lymph nodes under my arm.I was not eligible for partial breast irradiation initially.My breast cancer was found by imaging, not by feeling it, and confirmed with a needle biopsy.I have a lump in my breast that can be felt or seen on scans.I haven't had hormone therapy before surgery, except for cancer on the other side.I am planning to have a lumpectomy, but may consider a mastectomy if needed.I have had radiation therapy on the same side of my chest or breast before.
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.
Research Study Groups:
This trial has the following groups:- Group 1: Surgical Excision
- Group 2: Neoadjuvant partial breast irradiation
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are spaces available for participants in this experiment?
"According to the clinicaltrials.gov records, this study is still accepting candidates with initial posting on March 22nd 2019 and recent revisions made on January 3rd 2022."
Answered by AI
What is the estimated quantity of participants in this clinical trial?
"Affirmative. As indicated on clinicaltrials.gov, this medical trial is currently recruiting patients and has been since March 22nd 2019. The most recent update was made January 3rd 2022 with the aim of finding 50 participants across a single site."
Answered by AI
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