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

Study Overview
=================
Brief 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.

Detailed 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.

Official Title
-----------------
Research Registry for Intra-Operative Radiotherapy (IORT) During Breast Conserving Surgery in Patients With in Situ and Early Stage Breast Cancer

Conditions
-----------------
Early-stage Breast Cancer, Breast Carcinoma in Situ, Breast Neoplasms

Intervention / Treatment
-----------------
* Radiation: Intraoperative Radiation Therapy (IORT)


Participation 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IORT<br>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. | Radiation: Intraoperative Radiation Therapy (IORT)<br>* IORT involving 50kV Xrays to a dose of 20 Gy during breast-conserving surgery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Recurrence | Presence of recurrent tumor in ipsilateral breast or distant site | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease specific survival | survival | 10 years | 
| Overall Survival | survival | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Cancer, Early-stage Breast Cancer, Intraoperative Radiotherapy, IORT