Prospective Registry of Intraoperative Radiation Therapy Using Low Energy X-ray for Breast Cancer at Medical Center, Navicent Health
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 94
- Locations
- 1
- Primary Endpoint
- Rate of recurrence
Study Overview
Brief Summary
Intraoperative Breast Radiation Therapy (IORT-Breast) utilizing the Xoft Axxent Electronic Brachytherapy System (Xoft) has been recently introduced as a treatment option for women 50 years of age and older who have early stage, low risk Invasive Breast Cancer (IBC). Clinical trials have shown IORT to be non-inferior to whole breast radiation, however some concern continues with rates of recurrence and clinical outcomes.
Given the recent introduction and continued debate it is an excellent opportunity to observe and monitor outcomes in the patients that are treated at Navicent Health through this prospective, observational registry. The opportunity also permits examination of the participant's thoughts and feeling on Quality of Life and Cosmetic Appearance
Detailed Description
Objectives: (primary and important secondary objectives) The primary objective is to determine rates of recurrence at 5, and 10 years following IORT-Breast at Navicent Health.
Secondary objectives include determination of acute and late effects of IORT-Breast at the treatment site, cosmetic outcomes and satisfaction over 10 years.
In addition, the study will determine why patients who were scheduled for IORT-Breast did not receive it after lumpectomy.
Study Design:
Prospective, observational registry.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 55 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Signed informed consent and HIPAA authorization
- •T1 tumor (less than or equal to 20mm in greatest diameter)
- •Histological Grade 1 or 2
- •Node Negative
- •HER-2 -ve
Exclusion Criteria
- •Previous radiation therapy to the involved breast other than IORT within 6 months
- •High grade tumors (Histologic grade 3)
- •Her-2 Positive
- •Lymphovascular invasion
- •Metastatic disease
- •close proximity to or involvement of skin
- •Multifocal cancer
Arms & Interventions
Cohort B- Postoperative Prospective
Subjects who have had IORT performed within the previous 6 month who agree to participate.
Intervention: Lumpectomy (Procedure)
Cohort A- Preoperative Prospective
Subjects are eligible to receive IORT and have agreed to participate in the study prior to any intervention.
Intervention: Lumpectomy (Procedure)
Cohort A- Preoperative Prospective
Subjects are eligible to receive IORT and have agreed to participate in the study prior to any intervention.
Intervention: Intraoperative Radiation Therapy (Radiation)
Cohort B- Postoperative Prospective
Subjects who have had IORT performed within the previous 6 month who agree to participate.
Intervention: Intraoperative Radiation Therapy (Radiation)
Outcomes
Primary Outcomes
Rate of recurrence
Time Frame: 10 year
To determine rate of recurrence of disease at specific time period
Rate of recurrence
Time Frame: 5 year
To determine rate of recurrence of disease at specific time period
Secondary Outcomes
- Treatment Abandonment(5 years)
- Acute and late effects(5 years)