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Radiation Therapy
IOeRT for Breast Cancer
N/A
Waitlist Available
Led By Kyle Arneson, MD
Research Sponsored by Avera McKennan Hospital & University Health Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Unifocal (unicentric), invasive ductal carcinoma or favorable sub-types (mucinous, tubular, colloid) < 2.0 cm in diameter, primary T-stage of T1 (AJCC criteria)
Patient agrees to evaluation of the axilla with sentinel lymph node biopsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights
Study Summary
This trial is testing a new way to give partial breast irradiation that may be better than the current method.
Who is the study for?
This trial is for post-menopausal women over 60 with a specific type of early-stage breast cancer that hasn't spread to lymph nodes. Candidates must have negative surgical margins, be BRCA1/2 negative, and agree to breast conservation therapy and sentinel lymph node biopsy. They should not have received prior chemotherapy for this cancer or have certain aggressive cancer features.Check my eligibility
What is being tested?
The study tests if a single dose of Intraoperative Electron Radiation Therapy (IOeRT) after lumpectomy can prevent the recurrence of local breast cancer effectively while maintaining cosmetic appearance and minimizing side effects compared to traditional treatments.See study design
What are the potential side effects?
While the trial aims to reduce side effects, potential risks may include skin changes, pain at the treatment site, fatigue, infection risk increase due to radiation exposure, and possible long-term tissue damage or complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is a single, small tumor less than 2cm.
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I agree to have a sentinel lymph node biopsy to check my underarm area.
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My cancer is estrogen receptor positive.
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I agree to have part of my breast removed and radiation therapy for my breast cancer.
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I understand the study and can legally consent.
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My cancer has not spread to my lymph nodes.
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I am a woman over 60 and have not had a period in the last year.
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I do not have BRCA1 or BRCA2 gene mutations, if tested.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of patients who are free of breast cancer.
Secondary outcome measures
Local recurrance rate with acute toxicity and cosmetic evaluations
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single Fraction IOeRTExperimental Treatment1 Intervention
A single dose of 21 Gy calculated such that the 90% isodose line encompasses the posterior of the tumor bed will be administered.
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Who is running the clinical trial?
Avera McKennan Hospital & University Health CenterLead Sponsor
34 Previous Clinical Trials
29,087 Total Patients Enrolled
3 Trials studying Breast Cancer
25,054 Patients Enrolled for Breast Cancer
Kyle Arneson, MDPrincipal InvestigatorAvera Cancer Insitute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My immune system is weakened.My breast cancer is a single, small tumor less than 2cm.The edges of the removed tissue show no signs of cancer under a microscope.I have had breast cancer or another cancer that has not spread and is not expected to shorten my life within 5 years.My breast cancer has spread to my skin or chest wall.My condition is ductal carcinoma in situ (DCIS) of any grade.I am recommended to have chemotherapy before surgery.I have at least one lymph node that tested positive for cancer.My condition is considered severe.I agree to have a sentinel lymph node biopsy to check my underarm area.I cannot have breast-conserving surgery because I've had whole breast radiation before.I have LCIS along with my main breast condition.My cancer is estrogen receptor positive.My condition is mild or moderate.My cancer is HER2 positive.I agree to have part of my breast removed and radiation therapy for my breast cancer.I understand the study and can legally consent.My breast cancer is of the invasive lobular type.My breast cancer has a large area of non-invasive cells.There are signs that the cancer has spread to the lymphatic or blood vessels.My cancer is not driven by estrogen.My cancer has not spread to my lymph nodes.I am a woman over 60 and have not had a period in the last year.I have an active connective tissue disorder like scleroderma or lupus.I do not have BRCA1 or BRCA2 gene mutations, if tested.
Research Study Groups:
This trial has the following groups:- Group 1: Single Fraction IOeRT
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.
Are there any patient enrolment opportunities available for this clinical trial?
"According to clinicaltrials.gov, recruitment for this trial has closed since the last update on December 22nd 2021. There have been 2602 other studies posted to support research in the meantime."
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