Intraoperative Radiotherapy for Breast Cancer

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

265 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to examine the role of Intraoperative Radiotherapy (IORT) in Ductal Carcinoma In-Situ (DCIS) and to improve the understanding of the clinical, radiographic, and patient-related impact of adopting IORT.

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 IORT for breast cancer?

Research shows that intraoperative radiotherapy (IORT) can be effective for early stage breast cancer, offering similar outcomes to whole breast radiotherapy with potentially better quality of life. Studies indicate that IORT is a promising option for women with early stage breast cancer, providing targeted treatment during surgery. ^{1 2 3 4 5}

Is intraoperative radiotherapy (IORT) safe for breast cancer patients?

Intraoperative radiotherapy (IORT) for breast cancer has been studied in large trials and is generally considered safe with favorable toxicity profiles. It involves delivering a single dose of radiation during surgery, which can reduce the need for additional radiation sessions and has shown acceptable safety in terms of side effects. ^{5 6 7 8 9}

How is intraoperative radiotherapy (IORT) for breast cancer different from other treatments?

Intraoperative radiotherapy (IORT) for breast cancer is unique because it delivers a single dose of radiation directly to the surgical area immediately after tumor removal, reducing the need for multiple radiation sessions. This approach is particularly beneficial for select women with early-stage breast cancer, offering a more convenient and potentially less toxic alternative to traditional whole-breast radiation therapy. ^{1 3 10 11 12}

Research Team

Eileen Connolly, MD

Principal Investigator

Assistant Professor of Radiation Oncology

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Long-Term Results of Intraoperative Radiation Therapy for Early Breast Cancer Using a Nondedicated Linear Accelerator. [2023]

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

TARGIT-R (Retrospective): North American Experience with Intraoperative Radiation Using Low-Kilovoltage X-Rays for Breast Cancer. [2022]

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

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

4. Italy pubmed.ncbi.nlm.nih.gov

Intraoperative radiotherapy versus no radiotherapy for early stage low-risk breast cancer patients undergoing breast-conserving surgery: a propensity score matching study based on the SEER database. [2022]

5. England 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. [2021]

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

Multicenter Phase II Study of Intraoperative Radiotherapy of Early Breast Cancer: Ipsilateral Tumor Recurrence. [2019]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Radiation dose-event relationship after intraoperative radiotherapy as a boost in patients with breast cancer. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Intraoperative Radiotherapy for Breast Cancer. [2020]

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

Risk analysis of electronic intraoperative radiation therapy for breast cancer. [2019]

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

Single-center long-term follow-up after intraoperative radiotherapy as a boost during breast-conserving surgery using low-kilovoltage x-rays. [2011]

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

Intraoperative Radiation Therapy Versus Whole Breast Radiation for Early-Stage Breast Cancer Treatment in Rural Appalachia. [2021]

12. Switzerland pubmed.ncbi.nlm.nih.gov

[Intraoperative radiation therapy in conservative treatment of breast cancer: Quo Vadis?]. [2019]