Intra-Operative Radiation Registry

Study Overview
=================
Brief Summary
-----------------
This registry trial is designed to track the local control rates and side effects of IORT, which will be implemented for women who are suitable PBI per the latest ASTRO guidelines.

Detailed Description
-----------------
Eligible patients will be referred for radiation oncology consultation by the operating surgeon. Patients will be presented with all radiation options and if they choose IORT, they will be offered enrollment onto the registry trial and consented accordingly. The registry will collect treatment data from the operation, radiation and pathology notes post IORT for each patient enrolled. Sources of research material, i.e. resected breast tissue and lymph nodes, will be obtained as part of routine clinical care. No additional tissue will be collected from patients due to enrollment on this registry trial. No additional studies will be performed outside of the routine standard of care. Post treatment, the registry will collect data based on the standard of care follow up schedule. Follow-up visits will be scheduled 2-3 weeks post-operatively, as per standard of care, to review the final pathology and for the initial toxicity assessment. Patients found to have positive margins and/or lymph node involvement may require further surgery and/or additional external beam radiation. Additional follow-up visits with radiation oncology will be scheduled at 6 months and 1, 2, 3, 4, and 5 years following IORT. Toxicity will be scored using CTCAE v4.03. Local control will be evaluated using clinical exam and semi-annual to annual mammograms. All such information will be tracked and recorded into the registry database.

Official Title
-----------------
Intra-Operative Radiation Therapy (IORT) Using the IntraBeam® System - A Registry Protocol

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female gender Age ≥ 45 cT1-2N0, <3.5cm invasive breast cancer, estrogen-receptor positive or DCIS of breast, Grade 1-2, mammographically detected, < 2.5 cm, estrogen-receptor positive Suitable for breast conserving surgery No contraindication to radiation Mammogram within 6 months of planned procedure Fitness for lumpectomy under general anesthesia Planned to receive IORT Exclusion criteria Known axillary lymph node positive breast cancer (negative biopsy not required) Multicentric cancer in the same breast as diagnosed by clinical examination, mammography, ultrasound, MRI or pathologic assessment, not amenable to excision with negative margins with a single lumpectomy. Patients known to have BRCA 1/2 (breast cancer 1, breast cancer 2) gene Patients undergoing neoadjuvant chemotherapy

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

Sexes Eligible for Study
-----------------
Female

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with locally controlled disease | How many patients have recurrent disease following intra-operative radiation | 5 years following radiation therapy | 
| Number of patients with regionally controlled disease | How many patients have recurrent nodal disease following intra-operative radiation | 5 years following radiation therapy | 
| Number of patients with grade 2 or higher toxicities | How many patients have toxicity as measured by the CTCAE | 5 years following radiation therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intraoperative radiation therapy, partial breast irradiation