Lumpectomy Followed By Intraoperative Electron Radiation Therapy (IOERT)

Study Overview
=================
Brief Summary
-----------------
The overall objective of this study is to determine the feasibility and tolerability of single dose Intraoperative Electron Radiation Treatment (IOERT) as definitive therapy when administered at the time of breast conserving surgery for patients with early stage breast cancer.

Detailed Description
-----------------
Evaluate local and distant recurrence rates and cosmetic outcomes. Both clinical evaluation of cosmetic outcome by the Surgeon, and subjective impression of cosmetic outcome by the patient, are evaluated using questionnaire. Local recurrence is evaluated under the same imaging protocol used for Whole breast radiation.

Official Title
-----------------
Lumpectomy Followed By Intraoperative Electron Radiation Therapy (IOERT) As A Single, Full Dose Partial Breast Irradiation For Early Stage, Node Negative, Invasive Breast Cancer

Conditions
-----------------
Invasive Ductal Breast Cancer, Carcinoma Breast Stage I

Intervention / Treatment
-----------------
* Radiation: Intraoperative Electron Radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient agrees to breast conservation therapy (segmental resection, partial mastectomy, and radiation therapy) as the treatment for their breast cancer Patient agrees to evaluation of the axilla with sentinel lymph node biopsy Peri or post-menopausal women age > 50, defined as women who have experienced no menstrual period in the past 6 months or more BRCA1 and 2 gene mutation negative, if tested. [genetic testing is NOT required based upon personal or family history] Unifocal (unicentric), invasive ductal carcinoma or favorable sub-types (mucinous, tubular, colloid) < 2.0 cm in diameter, primary T-stage of Tis or T1 (AJCC criteria) Grade 1, 2, or 3 acceptable Associated LCIS is allowed Pure DCIS allowed if <2.5 cm, low to intermediate nuclear grade and resected margins negative at > 3 mm (per ASTRO criteria) Estrogen receptor (ER) status of positive Patient has clear margins >2 mm on gross pathologic examination Patient is node-negative, defined as N0 (i-) or N0 (i+) Patient must be deemed functionally and mentally competent to understand and sign the informed consent Neoadjuvant hormonal therapy is allowed if all other ASTRO suitable criteria have been met prior to onset of hormonal therapy Exclusion Criteria: Prior breast malignancy or other malignancy if metastatic, or with expected survival of < 5 years Immunocompromised status Pregnancy Women with an active connective tissue disorder (i.e. scleroderma, lupus and others) Breast cancer that involves the skin or chest wall, locally advanced breast cancer Invasive lobular carcinoma Evidence of lymphovascular invasion (LVI) Invasive carcinoma with extensive intraductal component (EIC) Neoadjuvant chemotherapy Patients with 1 or more positive lymph node determined during surgery with sentinel node and/or axillary dissection Someone who is not a candidate for breast conserving management, i.e., prior whole breast radiation therapy

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 95 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IOERT arm<br>Intraoperative electron radiotherapy (IOERT) is delivered after completion of the lumpectomy and sentinel node procedure. IOERT is performed on a mobile self-shielded magnetron-driven X-band linear accelerator specifically developed for use in the operating room. This machine produces megavoltage electron beams of energy ranging between 4 and 12 MeV. The radiation is delivered from the device to the tumor bed through an attached applicator. A single dose of 21 Gy calculated to the 90% depth posterior to the tumor bed will be administered and will last approximately 2.5 minutes. | Radiation: Intraoperative Electron Radiotherapy<br>* Intraoperative Electron Radiotherapy (IOERT) is delivered after completion of the lumpectomy and sentinel node procedure.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate change over time on the incidence of local and distance recurrence rates. | Subjects will be followed for recurrence rates at one month, three months, six months, twelve months, and then annually for up to 10 years. This will include: history and physical exam, as well as radiographic images at physician discretion and per study protocol. | 1 month, 3 months, 6 months, 12 months, and then annually for 10 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate changes in the short-term and long-term side effects related to IOERT | Assessment of the overall patient satisfaction related to the therapy and cosmetic outcome. Cosmesis will be scored by both the physician and patient using the RTOG cosmesis rating system at one month, three months, six months, twelve months, and 24 months. The secondary outcome measure will only take place in the first two years of the 10 year time frame for patient follow up. After 24 month evaluations, patients will only be followed for incidence of local and distance recurrence rates. | 1 month, 3 months, 6 months, 12 months, and then annually for 10 years. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stage I Breast Carcinoma