Intraoperative Radiation Therapy for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment for stage I-II breast cancer using a special type of radiation administered during surgery. The goal is to determine if a single dose of electron beam radiation (Intraoperative Electron Beam Radiotherapy Boost) can effectively kill cancer cells when applied directly to the area where a tumor was removed, before breast reconstruction. This approach might better shrink tumors and prevent recurrence. Patients diagnosed with stage I or II breast cancer, without cancer in their lymph nodes, are suitable candidates for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that intraoperative electron beam radiotherapy boost is safe for treating breast cancer?
Research has shown that intraoperative electron beam radiotherapy (IOERT) is generally well-tolerated by patients. Studies with breast cancer patients indicate that IOERT is a safe option with good results. For instance, one study found that most patients received this type of radiation without major problems. Another study supported these findings, suggesting that IOERT is both safe and effective.
Patients in these studies reported positive experiences with few side effects. Additionally, compared to other radiation methods, IOERT has a similar safety record. Overall, IOERT appears to be a good choice for patients undergoing a lumpectomy (surgery to remove a breast tumor) with reconstruction.12345Why do researchers think this study treatment might be promising?
Intraoperative Electron Beam Radiotherapy (IOERT) is unique because it delivers radiation directly to the breast cancer site during surgery, reducing the time and exposure needed compared to the traditional post-surgery radiation treatments. Unlike standard external beam radiation therapy, which typically requires multiple hospital visits over several weeks, IOERT can administer a precise, high dose of radiation in just one session. This targeted approach not only minimizes radiation exposure to healthy surrounding tissues but also potentially reduces the recurrence of cancer by delivering immediate treatment to the area at risk. Researchers are excited about IOERT because it could significantly streamline and improve the effectiveness of breast cancer treatment.
What evidence suggests that intraoperative electron beam radiotherapy boost is effective for treating stage I-II breast cancer?
Research has shown that intraoperative electron beam radiotherapy (IOERT) can effectively treat early-stage breast cancer. In this trial, participants will undergo a standard lumpectomy followed by one fraction of IOERT boost to the lumpectomy cavity. Studies have found that using IOERT during surgery as an additional boost can lead to better outcomes compared to traditional radiation methods. It is particularly effective when combined with whole breast irradiation (WBI) after breast-conserving surgery. Long-term results indicate that IOERT is as effective as external beam radiation in preventing cancer recurrence. Additionally, patients have reported good cosmetic results after treatment, which is important for many undergoing breast cancer surgery.12678
Who Is on the Research Team?
Jose Bazan, MD, MS
Principal Investigator
Ohio State University Comprehensive Cancer Center
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery and IOERT
Patients undergo standard of care lumpectomy and 1 fraction of intraoperative electron beam radiation therapy (IOERT) boost to the lumpectomy cavity
Oncoplastic Reconstruction and Whole Breast Radiation
Patients undergo standard of care oncoplastic reconstruction and whole breast radiation therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Intraoperative Electron Beam Radiotherapy Boost
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ohio State University Comprehensive Cancer Center
Lead Sponsor