Intraoperative Radiotherapy for Breast Cancer

Overseen By Janie Grumley, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: John Wayne Cancer Institute

Disqualifiers: Stage T3-4, N1-3, M1, multifocal

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial studies a treatment called Intraoperative Radiation Therapy (IORT) for women with early-stage breast cancer. The goal is to assess the safety and effectiveness of IORT during breast-conserving surgery, which aims to remove cancer while preserving as much of the breast as possible. Researchers will monitor patient outcomes, including side effects, cancer recurrence, and overall health. Women with a single breast cancer tumor smaller than 3 cm who are scheduled for a partial mastectomy may be suitable candidates for this trial. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in breast cancer care.

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 this treatment method is safe for women with early stage breast cancer?

Research has shown that Intraoperative Radiation Therapy (IORT) is generally safe for patients with early-stage breast cancer. Studies have found that skin reactions are usually milder with IORT compared to traditional external radiation. However, long-term effects like breast fibrosis, where the breast tissue becomes hard, can occur.

Patients have often tolerated IORT well. It has been used successfully in real-world clinical settings, with most patients not experiencing severe side effects. This treatment targets radiation directly to the area where the tumor was removed, reducing exposure to healthy tissue.

While no treatment is without risk, current evidence supports the safety of IORT for many women with early-stage breast cancer. Patients should always discuss potential risks and benefits with their doctor before deciding on a treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Intraoperative Radiation Therapy (IORT) is unique because it delivers radiation directly to the tumor site during surgery, unlike traditional radiation therapy, which often involves multiple sessions over several weeks. This method provides a concentrated dose of radiation right after the tumor is removed, potentially reducing the overall treatment time and sparing healthy surrounding tissue from exposure. Researchers are excited about IORT because it could lead to faster recovery times and fewer side effects, offering a more convenient and patient-friendly approach for those undergoing breast-conserving surgery for early-stage breast cancer.

What evidence suggests that Intraoperative Radiation Therapy (IORT) is effective for early stage breast cancer?

Research has shown that intraoperative radiation therapy (IORT), which participants in this trial may receive, effectively treats early-stage breast cancer. Studies have found that IORT offers similar results to traditional whole-breast radiation therapy but with milder side effects, such as skin irritation. Patients receiving IORT experience fewer long-term issues, like breast hardening, compared to those undergoing external beam radiation therapy. In real-world situations, IORT has successfully controlled cancer with low recurrence rates. Overall, it presents a promising option for patients seeking efficient and convenient treatment. ^{1 2 3 4 6}

Who Is on the Research Team?

Janie Grumley, MD

Principal Investigator

John Wayne Cancer Institute, Providence Saint John's Health Center

Are You a Good Fit for This Trial?

Inclusion Criteria

Clinical stage Tis, T1, or T2(≤ 3cm), N0, M0 (AJCC Classification)

Unifocal Disease

Candidate for breast-conserving surgery

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Intra-Operative Radiotherapy

Participants undergo partial mastectomy and receive intra-operative radiotherapy (IORT)

1 day

1 visit (in-person)

Follow-up

Participants are monitored for short and long-term outcomes, including perioperative complications and disease recurrence

5 years

Regular visits as per protocol

Long-term Follow-up

Participants are monitored for disease-specific and overall survival

10 years

What Are the Treatments Tested in This Trial?

Interventions

• Intraoperative Radiation Therapy (IORT)

How Is the Trial Designed?

Group I: IORT Experimental Treatment 1 Intervention

All participants who plan to undergo partial mastectomy for treatment of early stage breast cancer will be considered for eligibility for IORT. Patient with single breast cancer less than 3cm in disease span, clinical negative axillary node will be offered the option of having IORT. If IORT is delivered following surgical resection of the tumor they will be followed in this registry for short and long term outcomes.

Intraoperative Radiation Therapy (IORT) is already approved in United States, European Union for the following indications:

Approved in United States as Intraoperative Radiation Therapy for:

• Cervical cancer
• Colorectal cancer
• Soft tissue sarcoma
• Uterine cancer
• Breast cancer
• Pancreatic cancer

Approved in European Union as Intraoperative Radiation Therapy for:

• Colorectal cancer
• Uterine cancer
• Breast cancer
• Pancreatic cancer

Who Is Running the Clinical Trial?

John Wayne Cancer Institute

Lead Sponsor

Trials

22

Recruited

5,500+

Saint John's Cancer Institute

Lead Sponsor

Trials

27

Recruited

6,800+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12222354/

Intraoperative Radiation Therapy (IORT) for Breast Cancer IORT is extremely convenient for the patient and offers many advantages when compared with other methods of partial or whole breast treatment.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2405630825000904

IORT for early-stage, low-risk breast cancer This study reports on oncological outcomes in a real-world clinical setting and contributes to the understanding of its optimal indication.

3. breast-cancer-research.biomedcentral.com breast-cancer-research.biomedcentral.com/articles/10.1186/s13058-024-01936-0

Intraoperative radiotherapy versus ... - Breast Cancer Research We aimed to compare the outcome of IORT to that of whole-breast external beam radiotherapy (EBRT) in highly selected breast cancer patients.

4. astro.org astro.org/news-and-publications/news-and-media-center/news-releases/2025/astro-corrects-media-misinformation-on-breast-cancer-treatment-options

ASTRO corrects media misinformation on breast cancer ... While acute skin toxicity is less severe with IORT compared to external beam radiation, long-term toxicity such as breast fibrosis is ...

5. advancesradonc.org advancesradonc.org/article/S2452-1094(23)00062-3/fulltext

Long-Term Results of Intraoperative Radiation Therapy for ... To present the long-term results of intraoperative radiation therapy (IORT) for early breast cancer using a nondedicated linear accelerator.

6. spandidos-publications.com spandidos-publications.com/10.3892/ol.2025.15092

Long‑term follow‑up outcomes of intraoperative ... The current study was a retrospective cohort study exploring the efficacy, safety and cosmetics of IORT in patients with early-stage breast ...