Intraoperative Radiotherapy for Breast Cancer

Not currently recruiting at 1 trial location

Overseen By Eileen P. Connolly

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Invasive cancer, Multicentric cancer, Lymph node involvement, Severe disease, others

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

Compensation: Varies

Number of Visits: 1

Duration: Single session

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how Intraoperative Radiotherapy (IORT), a type of radiation treatment administered during surgery, can benefit individuals with Ductal Carcinoma In-Situ (DCIS), a non-invasive breast cancer. Researchers aim to understand IORT's effects on patients' quality of life and the condition itself. The trial includes two groups: one for high-grade DCIS and another for low/intermediate-grade DCIS. Women with a confirmed DCIS diagnosis, a single breast tumor less than 3.0 cm, and no lymph node involvement may be suitable candidates. Participants should be prepared to complete questionnaires and attend follow-ups for at least five years. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future treatment options for DCIS.

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 prior data suggests that this technique is safe for treating DCIS?

Research has shown that Intraoperative Radiotherapy (IORT) is generally safe and well-tolerated for treating breast cancer. Studies have found that breast cancer-specific survival rates remain high. One study reported a 99.7% survival rate over eight years, even in cases where the cancer recurred. This suggests that IORT remains a safe option even if the cancer returns.

The likelihood of cancer returning in the same area with IORT is quite low. In one study, only 2.1% of patients experienced a recurrence. Additionally, skin reactions are usually milder with IORT compared to other radiation treatments. However, some long-term side effects, such as thickening or scarring of breast tissue, may still occur.

While current findings are encouraging, researchers continue to study the long-term safety of IORT. Overall, IORT appears to be a safe choice for breast cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Intraoperative Radiotherapy (IORT) is unique because it delivers a concentrated dose of radiation directly to the tumor site during surgery, which is different from the traditional external beam radiation therapy that typically follows surgery and lasts several weeks. This method not only reduces the overall treatment time significantly but also minimizes exposure to surrounding healthy tissues, potentially leading to fewer side effects. Researchers are excited about IORT because it has the potential to improve the quality of life for patients by streamlining the treatment process and reducing the physical and emotional burden associated with prolonged radiation sessions.

What evidence suggests that IORT is effective for DCIS?

Research has shown that Intraoperative Radiotherapy (IORT) effectively treats some early-stage breast cancers. Studies have found IORT to be as safe and effective as traditional radiation therapy, with the added convenience of being administered during surgery. Data from the TARGIT trial suggested that IORT works well for early-stage invasive breast cancer and may lead to fewer deaths from causes other than breast cancer. In this trial, participants with Ductal Carcinoma In-Situ (DCIS) received IORT, which appeared to be a promising, safe, and effective treatment. While there are some differences in local cancer recurrence, overall survival rates are similar to other treatments. ^{2 3 6 7 8}

Who Is on the Research Team?

Eileen Connolly, MD

Principal Investigator

Assistant Professor of Radiation Oncology

Are You a Good Fit for This Trial?

This trial is for women with a specific breast condition called DCIS, who are fit enough for surgery and radiation (ECOG 0-3), have no invasive cancer or multiple tumors in one breast, no lymph node involvement, and not pregnant. They must be able to follow up for 5 years and use birth control if of childbearing age.

Inclusion Criteria

I am scheduled for radiation therapy to my breast only.

I can care for myself but may not be able to do active work.

I am a woman who can have children and have a negative pregnancy test.

Exclusion Criteria

Pregnant or breast feeding women

I have been diagnosed with invasive breast cancer.

I have multiple tumors in one breast that cannot be removed with a single surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Intraoperative Radiation Therapy (IORT) during lumpectomy

Single session

1 visit (in-person)

Follow-up

Participants are monitored for safety, effectiveness, and recurrence after treatment

5 years

Regular visits as per study protocol

Long-term follow-up

Participants are monitored for long-term radiation toxicity and overall survival

5 years

What Are the Treatments Tested in This Trial?

Interventions

• IORT

Trial Overview The study tests Intraoperative Radiotherapy (IORT) as a treatment option for Ductal Carcinoma In-Situ (DCIS) of the breast. It aims to understand its effects on clinical outcomes, imaging results, and patient quality of life through questionnaires.

How Is the Trial Designed?

Group I: Low/Intermediate Grade DCIS Experimental Treatment 1 Intervention

Subjects with Low/Intermediate Grade DCIS will complete quality of life questionnaires before and after the IORT.

Group II: High Grade DCIS Experimental Treatment 1 Intervention

Subjects with High Grade DCIS will complete quality of life questionnaires before and after the IORT.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Published Research Related to This Trial

Intraoperative radiotherapy (IORT) for early-stage breast cancer significantly improves radiation-related quality of life (QoL) parameters, with patients reporting less pain and better functioning compared to those receiving external beam radiotherapy (EBRT).

In a study of 230 women, those treated with IORT alone experienced fewer breast and arm symptoms and better overall role functioning, indicating that IORT may be a more patient-friendly option than traditional EBRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation-related quality of life parameters after targeted intraoperative radiotherapy versus whole breast radiotherapy in patients with breast cancer: results from the randomized phase III trial TARGIT-A. Welzel, G., Boch, A., Sperk, E., et al.[2021]

Intraoperative radiotherapy (IORT) for early-stage breast cancer has been shown to be safe and effective, with two large randomized trials confirming its efficacy in thousands of women, allowing for targeted treatment of high-risk tissue during surgery.

IORT offers several advantages, including reduced treatment time, lower toxicity, and improved patient convenience, but it may require additional whole breast radiation if final pathology reveals unexpected findings, which could limit some of its benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative Radiotherapy for Breast Cancer. Harris, EER., Small, W.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39439951/

Comparative long-term oncological outcomes of ... At a long-term follow-up, the LRR rate was higher in the BCS followed by IORT, without significant differences in metastasis-free or overall survival rates.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11493767/

Comparative long-term oncological outcomes of ... At a long-term follow-up, the LRR rate was higher in the BCS followed by IORT, without significant differences in metastasis-free or overall survival rates.

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

IORT for early-stage, low-risk breast cancer IORT has been associated with lower non–breast cancer mortality, as reported in the long-term results of the TARGIT-A trial[3], which observed fewer deaths ...

4. redjournal.org redjournal.org/article/S0360-3016(12)01612-4/fulltext

Intraoperative Radiation Therapy (IORT) for Ductal ... Published data from the TARGIT trial have shown that IORT is effective in treating select early stage invasive breast cancer with short-term follow up. We ...

5. blogs.the-hospitalist.org blogs.the-hospitalist.org/content/intraoperative-radiation-looks-good-dcis

Intraoperative radiation looks good for DCIS | MDedge Key clinical point: Intraoperative radiation appears safe and effective, and is more convenient than postoperative radiation. Major finding: ...

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

Long‑term follow‑up outcomes of intraoperative ... However, the long‑term outcomes and safety of IORT in patients with breast cancer remain incompletely understood.

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

Intraoperative Radiation Therapy (IORT) for Breast Cancer Our breast-cancer-specific survival at 8 -years was 99.7% despite 106 local recurrences. This speaks to the safety of IORT and the treatability ...

8. 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 ...