IORT-Breast at Medical Center Navicent Health

Breast Cancer Female Clinical Trial

— IORT-Breast  

Official title:

Prospective Registry of Intraoperative Radiation Therapy Using Low Energy X-ray for Breast Cancer at Medical Center, Navicent Health

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04595435
• Other study ID #: IRB00092014
• Secondary ID: H1901940IORT
• Status: Active, not recruiting
• Start date: March 19, 2019
• Est. completion date: December 31, 2029

Study information

• Verified date: January 2024
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms
• Early-stage Breast Cancer

Intervention

Procedure:
• Lumpectomy
Removal of lump/tumor from breast utilizing an approach that saves as much breast as possible.

Radiation:
• Intraoperative Radiation Therapy
Delivery of low energy radiation therapy directly at surgical site, immediately removal of lump and tissue prior to final surgical closure

Locations

Country	Name	City	State
United States	Medical Center, Navicent Health	Macon	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Atrium Health Navicent

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of recurrence	To determine rate of recurrence of disease at specific time period	5 year
Primary	Rate of recurrence	To determine rate of recurrence of disease at specific time period	10 year
Secondary	Acute and late effects	To determine the rate of acute and late effects of IORT at the treatment site. Periodic review by surgeon and self reports identifying acute and late effects and calculating the rate of incidence for the treated group.	5 years
Secondary	Treatment Abandonment	To determine rate and reason for abandoning procedure after being scheduled for procedure. Calculating the rate of those who were scheduled to receive IORT and then did not receive the treatment as planned and reason why they did not receive the treatment.	5 years