Intraoperative Radiation Therapy for Breast Cancer

Recruiting at 4 trial locations

Overseen By Sohyun McElroy

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Stage III/IV cancer, Prior malignancy, Pregnancy, Lupus, Scleroderma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

108 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Intraoperative Electron Beam Radiotherapy Boost for breast cancer?

Research shows that using intraoperative electron radiotherapy (IOERT) as a boost during breast-conserving surgery can reduce the risk of cancer returning in the same area. It also offers benefits like easier scheduling with other treatments and less strain on radiotherapy clinics. ^{1 2 3 4 5}

Is intraoperative radiation therapy for breast cancer safe?

Intraoperative radiation therapy for breast cancer has been studied and generally shows a good safety profile. Some patients experienced mild complications like breast pain, fibrosis (thickening and scarring of tissue), and fat necrosis (death of fat tissue), but these were manageable and resolved over time. Overall, it appears to be a feasible and safe option for treating early-stage breast cancer. ^{2 4 6 7 8}

How is intraoperative radiation therapy different from other breast cancer treatments?

Intraoperative radiation therapy for breast cancer is unique because it delivers a single, high dose of radiation directly to the tumor site during surgery, which can reduce the overall treatment time and limit radiation exposure to surrounding healthy tissues. This approach can be used as a standalone treatment or as a boost in combination with whole-breast irradiation, offering similar local control and cosmetic results to standard treatments. ^{1 5 8 9 10}

What is the purpose of this trial?

This phase II trial studies the side effects of intraoperative electron beam radiotherapy boost and to see how well it works in treating patients with stage I-II breast cancer undergoing surgery with reconstruction. Giving a single dose of electron beam radiation to the tumor cavity during the breast surgery before reconstruction may be a better way to kill tumor cells and shrink tumors.

Research Team

Jose Bazan, MD, MS

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

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

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 been diagnosed with breast cancer by a pathologist.

Exclusion 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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and IOERT

Patients undergo standard of care lumpectomy and 1 fraction of intraoperative electron beam radiation therapy (IOERT) boost to the lumpectomy cavity

1 day

1 visit (in-person)

Oncoplastic Reconstruction and Whole Breast Radiation

Patients undergo standard of care oncoplastic reconstruction and whole breast radiation therapy

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Follow-up at 1 month, 6 months, 1 year, and annually thereafter

Treatment Details

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.

Participant Groups

Group I: Treatment (IOERT boost) Experimental Treatment 6 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.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

References

1. Turkey pubmed.ncbi.nlm.nih.gov

Long-term results of breast cancer patients who received IOERT as boost during BCS: A single-institution retrospective analysis. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Electron intraoperative treatment in patients with early-stage breast cancer: data update. [2007]

3. United States pubmed.ncbi.nlm.nih.gov

Intraoperative radiation therapy delivered prior to lumpectomy for early-stage breast cancer: a single institution study. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Intraoperative radiation therapy with electrons in breast cancer conservative treatment: our experience. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Intraoperative Tumor Bed Boost With Electrons in Breast Cancer of Clinical Stages I Through III: Updated 10-Year Results. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Intraoperative electron radiotherapy boost as a component of adjuvant radiation for breast cancer in the community setting. [2012]

7. United States pubmed.ncbi.nlm.nih.gov

Preliminary results of electron intraoperative therapy boost and hypofractionated external beam radiotherapy after breast-conserving surgery in premenopausal women. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Intraoperative electron radiotherapy in early invasive ductal breast cancer: 6-year median follow-up results of a prospective monocentric registry. [2022]

9. France pubmed.ncbi.nlm.nih.gov

[Debate: Pro intraoperative radiation therapy in breast cancer]. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Intraoperative irradiation: a pilot study combining external beam photons with "boost" dose intraoperative electrons. [2019]