IORT with Xoft Axxent System for Breast Cancer

Overseen By Maen Farha, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: MedStar Franklin Square Medical Center

Disqualifiers: Pregnancy, Auto-immune disease, Pacemaker, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

100 Participants Needed

Trial Summary

What is the purpose of this trial?

Single arm, prospective, multi-center, non-randomized study of subjects treated with single fraction, intra-operative radiation therapy at the time of lumpectomy for early stage breast cancer.To assess the rate of ipsilateral breast tumor recurrence in subjects treated with the Xoft Axxent Electronic Brachytherapy System when used for single-fraction, intra-operative radiation therapy treatment of early stage breast cancer when compared to whole breast irradiation (WBI) at 5 years of follow-up. The results of this single arm study will be compared to whole breast irradiation (WBI).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the Xoft Axxent Electronic Brachytherapy System treatment for breast cancer?

Research shows that the Xoft Axxent Electronic Brachytherapy System is a promising treatment for early-stage breast cancer, as it delivers targeted radiation with less exposure to normal tissues compared to other methods. It simplifies the process by not requiring special shielding and has been associated with effective outcomes in preliminary studies. ^{1 2 3 4 5}

Is the Xoft Axxent System safe for use in humans?

The Xoft Axxent System has been evaluated for safety in treating early-stage breast cancer and endometrial cancer. Studies suggest it delivers less radiation to normal tissues compared to some other methods, and it does not require a shielded vault for treatment. However, high skin doses can occur if the device is placed too close to the skin, which may lead to skin issues. ^{1 2 5 6 7}

How is the Xoft Axxent System treatment for breast cancer different from other treatments?

The Xoft Axxent System is unique because it uses an electronic source to produce X-rays for accelerated partial breast irradiation, eliminating the need for a high-dose-rate afterloader unit or a shielded vault, unlike traditional brachytherapy methods. This system delivers less radiation to normal tissues and can optimize skin dose, making it potentially safer and more convenient for patients. ^{1 2 4 5 6}

Research Team

Maen Farha, MD

Principal Investigator

Medstar Health Research Institute

Eligibility Criteria

This trial is for women over 40 with early-stage breast cancer, where the tumor is less than 3cm and hasn't spread. It's open to those who haven't had recurrent breast cancer or certain genetic mutations, aren't pregnant or nursing, don’t have significant autoimmune diseases or a pacemaker in the radiation field, and haven’t received prior treatments that could affect the study.

Inclusion Criteria

Women of child-bearing potential must have a negative pregnancy test within one week of IORT treatment

Subject must have provided written Informed Consent

I agree to use effective birth control during and after my treatment.

Exclusion Criteria

I cannot undergo radiation therapy due to health risks.

My cancer has spread to my lymph or blood vessels.

I have a BRCA 1 or 2 mutation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intra-Operative Radiation Therapy

Participants receive single fraction, intra-operative radiation therapy at the time of lumpectomy for early stage breast cancer

1 day

1 visit (in-person)

Follow-up

Participants are monitored for ipsilateral breast tumor recurrence and other outcomes

5 years

Treatment Details

Interventions

• Xoft Axxent Electronic Brachytherapy System

Trial Overview The study tests intra-operative radiation therapy (IORT) using Xoft Axxent eBx System during lumpectomy in patients with early-stage breast cancer. The goal is to compare this single treatment's effectiveness against traditional whole breast irradiation after five years.

Participant Groups

Group I: XOFT-Intra-Operative Radiation Therapy Experimental Treatment 1 Intervention

XOFT-Intra-Operative Radiation Therapy

Who Is Running the Clinical Trial?

MedStar Franklin Square Medical Center

Lead Sponsor

Trials

2

Recruited

110+

Medstar Health Research Institute

Collaborator

Trials

202

Recruited

187,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Experience with an electronic brachytherapy technique for intracavitary accelerated partial breast irradiation. [2010]

2. England pubmed.ncbi.nlm.nih.gov

Xoft Axxent electronic brachytherapy: a new device for delivering brachytherapy to the breast. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Dosimetric effects of saline- versus water-filled balloon applicators for IORT using the model S700 electronic brachytherapy source. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Multi-center study on patient selection for and the oncologic safety of intraoperative radiotherapy (IORT) with the Xoft Axxent® eBx® System for the management of early stage breast cancer in Taiwan. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Modeling study for optimization of skin dose for partial breast irradiation using Xoft Axxent electronic brachytherapy applicator. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Design and dosimetric characteristics of a new endocavitary contact radiotherapy system using an electronic brachytherapy source. [2017]

7. England pubmed.ncbi.nlm.nih.gov

Prospective multi-center trial utilizing electronic brachytherapy for the treatment of endometrial cancer. [2021]