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Brachytherapy

IORT with Xoft Axxent System for Breast Cancer

N/A
Waitlist Available
Led By Maen Farha, MD
Research Sponsored by MedStar Franklin Square Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women of child-bearing potential must agree to use adequate contraceptive precautions (defined as intrauterine devices, surgical contraceptives or a combination of condom and spermicide) from the time of negative pregnancy test through completion of the radiation treatment period
Subject must be female ≥ 40 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial will compare the rate of ipsilateral breast tumor recurrence in subjects treated with a single fraction of intra-operative radiation therapy using the Xoft Axxent Electronic Brachytherapy System to those treated with whole breast irradiation at 5 years of follow-up.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects of IORT are not listed here, common ones from similar procedures include skin changes like redness and irritation, fatigue, discomfort at the treatment site, and potential risks associated with anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to use effective birth control during and after my treatment.
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I am a woman aged 40 or older.
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I have been diagnosed with a type of breast cancer that started in the milk ducts.
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My cancer is in the early stages and has not spread beyond its original site.
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My tumor is smaller than 3.0 cm in size.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
tumor recurrence

Trial Design

1Treatment groups
Experimental Treatment
Group I: XOFT-Intra-Operative Radiation TherapyExperimental Treatment1 Intervention
XOFT-Intra-Operative Radiation Therapy

Find a Location

Who is running the clinical trial?

MedStar Franklin Square Medical CenterLead Sponsor
1 Previous Clinical Trials
27 Total Patients Enrolled
Medstar Health Research InstituteOTHER
188 Previous Clinical Trials
115,521 Total Patients Enrolled
7 Trials studying Breast Cancer
1,268 Patients Enrolled for Breast Cancer
Maen Farha, MDPrincipal InvestigatorMedstar Health Research Institute

Media Library

Xoft Axxent Electronic Brachytherapy System (Brachytherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03561454 — N/A
Breast Cancer Research Study Groups: XOFT-Intra-Operative Radiation Therapy
Breast Cancer Clinical Trial 2023: Xoft Axxent Electronic Brachytherapy System Highlights & Side Effects. Trial Name: NCT03561454 — N/A
Xoft Axxent Electronic Brachytherapy System (Brachytherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03561454 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment currently open for this investigation?

"As seen on clinicaltrials.gov, this trial is currently accepting applications from eligible patients. The listing was originally published on November 1st 2019 and has since been modified as of August 30th 2021."

Answered by AI

Is geriatric participation being accepted in this experiment?

"According to the stated prerequisites for this research, prospective patients must have attained a minimum age of 40 and not exceed 100."

Answered by AI

How many individuals are participating in this experiment?

"Affirmative. Clinicaltrials.gov indicates that this study, which was first published on November 11th 2019 and last revised August 30th 2021 is actively enrolling participants. The trial seeks to recruit a total of 50 patients from one clinical centre."

Answered by AI

Is participation in this experiment an option for me?

"This clinical trial is targeting 50 individuals between 40 and 100 years of age that have been diagnosed with breast cancer."

Answered by AI
~46 spots leftby Aug 2028