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Intraoperative Radiation Therapy for Breast Cancer
Phase 2
Recruiting
Led By Jose Bazan, MD, MS
Research Sponsored by Ohio State University Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 5 years
Awards & highlights
Study Summary
This trial looks at the side effects of giving a single dose of electron beam radiation to the tumor cavity during breast surgery before reconstruction.
Who is the study for?
This trial is for women with stage I-II breast cancer who are clinically node negative and have no distant metastases. They must not have had previous invasive breast cancers (except LCIS), be non-pregnant, non-lactating, and willing to use contraception during radiation therapy. Exclusions include prior chest radiotherapy, bilateral or multiple cancers not removable through one incision, active lupus or scleroderma, among others.Check my eligibility
What is being tested?
The trial tests intraoperative electron beam radiotherapy as a boost during surgery before reconstruction in patients with early-stage breast cancer. It aims to see if delivering this single dose of radiation directly to the tumor site is effective in killing remaining tumor cells and reducing the tumor size.See study design
What are the potential side effects?
Potential side effects may include skin changes at the treatment site, fatigue, discomfort from the procedure itself, possible wound healing complications due to radiation exposure during surgery, and typical risks associated with surgical procedures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 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 adverse events in the first 30 patients enrolled as graded by the National Cancer Institute Common Toxicity Criteria version 4.0
Rate of grade 3 fibrosis using the Late Effects Normal Tissue Task Force-Subjective, Objective, Management, Analytic scales
Secondary outcome measures
Change in self-reported cosmesis using the BCTOS
Physician reported cosmesis using the Harvard Breast Cosmesis scale and digital photographs
Quality of life assessed by Breast Cancer Treatment Outcome Scale
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (IOERT boost)Experimental Treatment6 Interventions
Patients undergo standard of care lumpectomy and then undergo 1 fraction of IOERT boost to the lumpectomy cavity. Patients then undergo standard of care oncoplastic reconstruction and whole breast radiation therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lumpectomy
2008
N/A
~670
Radiation Therapy
2017
Completed Phase 3
~7250
Reconstructive Surgery
2016
N/A
~70
Find a Location
Who is running the clinical trial?
Ohio State University Comprehensive Cancer CenterLead Sponsor
320 Previous Clinical Trials
289,991 Total Patients Enrolled
22 Trials studying Breast Cancer
2,884 Patients Enrolled for Breast Cancer
Jose Bazan, MD, MSPrincipal Investigator - Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
1 Previous Clinical Trials
61 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You can participate if you have had lobular breast carcinoma in situ (LCIS), but not if you have had any other type of breast cancer.You have advanced stage breast cancer that has spread to nearby lymph nodes or other parts of the body.You have two or more cancers that cannot be removed through one small incision.You have had radiation treatment to the same area of the breast before.You have cancer in both of your breasts.You have a type of breast cancer that is not epithelial, such as sarcoma or lymphoma.Men with breast cancer.You have early stage breast cancer that has not spread to the lymph nodes.Your doctor may recommend an ultrasound and biopsy of lymph nodes in your armpit before surgery if they think it's necessary.You have only ductal breast carcinoma in situ (DCIS).You have Paget's disease of the nipple.You have been diagnosed with breast cancer by a pathologist.You currently have a severe autoimmune disease or a history of certain skin conditions with active symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (IOERT boost)
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.
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