IOeRT for Breast Cancer

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Avera McKennan Hospital & University Health Center

Disqualifiers: Prior malignancy, Immuno-compromised, Pregnancy, others

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

Compensation: Varies

Number of Visits: 1

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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 Single Fraction IOeRT for breast cancer?

Research shows that intraoperative electron radiotherapy (IOERT) for breast cancer, when used as a boost or as full-dose partial breast irradiation, has excellent long-term local control rates, even in high-risk groups. In one study, a 9 Gy IOERT boost combined with whole breast irradiation provided a 98.4% local tumor control rate at 5 years, with limited postoperative complications. ^{1 2 3 4 5}

Is IOeRT safe for use in humans?

IOeRT (intraoperative electron radiotherapy) has been used safely in breast cancer treatment, with studies showing it generally has a low rate of side effects. Some patients experienced mild pain, delayed wound healing, or fat necrosis (a condition where fat tissue is damaged), but these issues were typically resolved over time. Overall, IOeRT is considered a feasible and safe option with good cosmetic outcomes. ^{3 6 7 8 9}

How does the treatment IOeRT for breast cancer differ from other treatments?

IOeRT (intraoperative electron radiotherapy) is unique because it delivers a high dose of radiation directly to the tumor bed during surgery, which helps avoid missing the target area and spares the skin, leading to better cosmetic outcomes. It also shortens the overall treatment time compared to traditional whole breast irradiation and has shown excellent long-term local control rates, even in high-risk breast cancer groups. ^{3 10 11 12 13}

What is the purpose of this trial?

The purpose of this study is to determine if lumpectomy followed by Intraoperative Electron Radiation Therapy (IOeRT) as a single, full dose partial breast irradiation will have as good or better results in preventing recurrence of local breast cancer, cosmetic appearance and early and late side effects.

Research Team

Kyle Arneson

Principal Investigator

Avera Cancer Insitute

Eligibility Criteria

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.

Inclusion Criteria

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 agree to have a sentinel lymph node biopsy to check my underarm area.

Exclusion Criteria

My immune system is weakened.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Radiation

Participants undergo lumpectomy and receive a single dose of Intraoperative Electron Radiation Therapy (IOeRT)

1 day

1 visit (in-person)

Post-Surgery Consultation

Participants meet with a medical oncologist to discuss chemotherapy and/or hormone therapy if indicated

1-2 weeks

Follow-up

Participants are monitored for safety, effectiveness, and cosmetic outcomes after treatment

10 years

Regular visits with surgeon, radiation oncologist, and research staff

Treatment Details

Interventions

• Single Fraction IOeRT

Trial Overview 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.

Participant Groups

Group I: Single Fraction IOeRT Experimental Treatment 1 Intervention

A single dose of 21 Gy calculated such that the 90% isodose line encompasses the posterior of the tumor bed will be administered.

Who Is Running the Clinical Trial?

Avera McKennan Hospital & University Health Center

Lead Sponsor

Trials

35

Recruited

29,200+

Findings from Research

Intraoperative radiotherapy (IORT) is an emerging treatment option for early-stage breast cancer that aims to reduce the volume of treatment, minimize toxicity, and shorten treatment duration after breast-conserving surgery.

The implementation of IORT in community cancer centers involves various challenges, including licensing, staffing, technical support, and reimbursement, which need to be addressed for successful adoption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative radiotherapy for breast cancer: its perceived simplicity. Ash, RB., Williams, VL., Wagman, LD., et al.[2013]

References

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

Recurrence rates for patients with early-stage breast cancer treated with IOERT at a community hospital per the ASTRO consensus statement for APBI. [2020]

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

Early experience with ultrasound features after intrabeam intraoperative radiation for early stage breast cancer. [2016]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Intraoperative Electron Radiotherapy (IOERT) in the Treatment of Primary Breast Cancer. [2020]

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

Oncological outcome, postoperative complications, and mammographic changes after intraoperative radiotherapy with electrons (IOERT) as a boost in a large single-institution cohort of breast cancer patients. [2021]

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

Intraoperative radiotherapy for breast cancer: its perceived simplicity. [2013]

6. Iran pubmed.ncbi.nlm.nih.gov

Assessment of Thyroid Lobe Dose in Breast Cancer Intraoperative Radiotherapy. [2022]

7. 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]

8. Ireland pubmed.ncbi.nlm.nih.gov

ESTRO IORT Task Force/ACROP recommendations for intraoperative radiation therapy with electrons (IOERT) in breast cancer. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Early Outcome, Cosmetic Result and Tolerability of an IOERT-Boost Prior to Adjuvant Whole-Breast Irradiation. [2023]

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

Long-Term Outcomes Using Electron IOERT APBI for Early Stage Breast Cancer: The Verona University Hospital Experience. [2022]

11. Egypt pubmed.ncbi.nlm.nih.gov

Early invasive cancer and partial intraoperative electron radiation therapy of the breast: experience of the jules bordet institute. [2021]

12. Ireland pubmed.ncbi.nlm.nih.gov

On-line optimization of intraoperative electron beam radiotherapy of the breast. [2022]

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

Intraopertive radiation therapy for breast cancer. [2019]