Clinical trial NCT04595435: IORT-Breast at Medical Center Navicent Health
Official title: Prospective Registry of Intraoperative Radiation Therapy Using Low Energy X-ray for Breast Cancer at Medical Center, Navicent Health
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer Female
Early-stage Breast Cancer
Keywords: Intraoperative Radiation Therapy
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Atrium Health Navicent
First posted: 2020-10-20
Enrollment: 94
Sex: FEMALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated at Navicent Health who meet eligibility criteria for IORT-Breast or who have received IORT-Breast within the previous 6 months

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.

Setting/Participants:

The study focuses on outpatients/short stay surgery performed at the Medical Center, Navicent Health, Macon, GA only.

Participants have been deemed eligible for IORT-Breast or have received IORT-Breast within the last 6 months. Key eligibility criteria for IORT- Breast includes women, aged 55 years old or greater, diagnosed with clinically node negative, grade 1 or 2 Invasive Breast Cancer with no lymphovascular invasion, that is 20mm or less in greatest dimension, Estrogen Receptor (ER) positive, HER 2 Neu Negative, and with a depth greater than 10mm from skin.

Study Interventions and Measures:

Participants will be eligible for IORT-Breast or have received IORT-Breast in the previous 6 months. Participants who were scheduled for IORT-Breast and do not receive IORT-Breast will have reasons for not receiving IORT-Breast recorded and will not be followed further. Participants receiving IORT-Breast will have treatment parameters recorded and will be followed every 6 months for 2 years and then annually until up to 10 years following treatment.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent and HIPAA authorization
* T1 tumor (less than or equal to 20mm in greatest diameter)
* Unifocal
* Histological Grade 1 or 2
* Node Negative
* ER +ve
* 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

Primary outcomes:
measure: Rate of recurrence
timeFrame: 5 year
measure: Rate of recurrence
timeFrame: 10 year
Secondary outcomes:
measure: Acute and late effects
timeFrame: 5 years
measure: Treatment Abandonment
timeFrame: 5 years
Other outcomes:
Locations:
city: Macon
country: United States
facility: Medical Center, Navicent Health
state: Georgia
Study officials:
affiliation: Atrium Health Navicent Physician's Group
name: Paul Dale, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Georgia Radiation Oncology
name: David Cole, MD
role: PRINCIPAL_INVESTIGATOR
References: