Breast Cancer Clinical Trial

Registry for Intra-Operative Radiotherapy During Breast Conserving Surgery in Patients With Early Stage Breast Cancer

Summary

This is a prospective, registry study that will enroll all women with early stage breast cancer who will be treated with intraoperative radiotherapy (IORT) during breast-conserving surgery. The purpose of this study is to further validate the long-term effectiveness and safety of this treatment method. We aim to assess short and long-term patient outcomes associated with IORT, including perioperative complications, local and distance disease recurrences, as well as disease-free survival and overall survival.

View Full Description

Full Description

At Providence Saint John's Health Center, there is the ongoing integration of Intra-Operative Radiation Therapy (IORT) as a standard treatment option among Breast Conserving Therapy (BCT) for individuals with in situ and early stage breast cancer. Currently, approximately 60 women per year are being treated with IORT. No repository of information of patient outcomes with this treatment has been established. This leaves a critical gap in the ability to assess the long-term outcomes of patients treated with IORT.

As the practice of using IORT to treat early stage and in situ breast cancer continues to grow at Providence Saint John's Health Center, this registry will provide the data needed to compare patient outcomes with those being treated with the traditional whole breast radiation therapy. In addition, the Providence Health & Services strives to improve patient care and outcomes with excellence whenever possible. The registry will provide the data needed to compare patient outcomes to national and community standards that can inform internal practice patterns and contribute to advancing breast cancer care nationally and internationally.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Clinical stage Tis, T1, or T2(≤ 3cm), N0, M0 (AJCC Classification)
Unifocal Disease
Candidate for breast-conserving surgery
Recommended treatment by multidisciplinary team

Exclusion Criteria:

Clinical stage T3-4, N1-3, M1
Multifocal disease

Study is for people with:

Breast Cancer

Estimated Enrollment:

1000

Study ID:

NCT04603209

Recruitment Status:

Recruiting

Sponsor:

Saint John's Cancer Institute

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

John Wayne Cancer Institute, Providence Saint John's Health Center
Santa Monica California, 90404, United States More Info
Janie Grumley, MD
Contact
310-582-7100
[email protected]
Robert Wollman, MD
Sub-Investigator
Lisa Chaiken, MD
Sub-Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

1000

Study ID:

NCT04603209

Recruitment Status:

Recruiting

Sponsor:


Saint John's Cancer Institute

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.