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
Trial Overview
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.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ohio State University Comprehensive Cancer Center
Lead Sponsor
Citations
Early Outcome, Cosmetic Result and Tolerability of an ...
Our study with 139 breast cancer patients treated with intraoperative radiotherapy reports favorable data on the cosmetic outcome as well as ...
Intraoperative Radiotherapy as a Tumour-Bed Boost ...
IORT boost+WBI is more effective than conventional radiotherapy after breast-conserving surgery in patients with early-stage breast cancer, and ...
Long-term oncologic outcome of intraoperative ...
In this study, we aimed to investigate the long-term oncologic outcomes of Korean patients who received IORT with low-energy X-ray as a tumor-bed boost. Methods.
Long-Term Outcomes of an International Cooperative ...
•Intraoperative radiotherapy as an upfront boost for breast cancer seems effective. •Ten-year local control rates are similar to those of external beam ...
Postoperative cosmetic outcome of intraoperative ...
In this study, we aim to evaluate the cosmetic outcome differences between Intraoperative electron beam radiation therapy (IOERT) and whole breast radiotherapy ...
Full-Dose Intraoperative Electron Radiotherapy for Early ...
Our data confirmed that IOERT is a feasible and valid therapeutic option in low-risk BC patients treated with lumpectomy.
Long‑term follow‑up outcomes of intraoperative ...
These findings suggest that IORT offers comparable safety, improved cosmesis and greater cost‑effectiveness than PORT, supporting its ...
Feasibility of Intraoperative Radiotherapy Tumor Bed Boost ...
Conclusion: Most patients successfully received IORT as a tumor bed boost after neoadjuvant chemotherapy. Thus, IORT may be a safe and feasible ...
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