Xoft® Intraoperative Radiotherapy (IORT) for Patients With Early-Stage Breast Cancer
Public ClinicalTrials.gov record NCT04088435. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Prospective Observational Trial of Xoft® Intraoperative Radiotherapy (IORT) as a Component of Breast Conserving Therapy (BCT) in Patients With Early-Stage Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Intraoperative radiotherapy (IORT) is a type of accelerated partial breast irradiation (APBI) in which radiation therapy is delivered to the breast tissue in a single treatment at the time of lumpectomy for breast cancer. The Xoft device (Axxent, Xoft, San Jose, CA) is a device that allows for IORT for breast cancer using kilovoltage (kV) photons. A central goal of this study is to report acute and late toxicities and cosmetic outcomes following breast IORT with the Xoft device in women with early-stage breast cancer treated with lumpectomy. The investigators hypothesize that IORT following lumpectomy will be safe and well tolerated with a lower rate of physician reported acute side effects than traditional whole breast radiation therapy after lumpectomy.
Study identification
- NCT ID
- NCT04088435
- Recruitment status
- Terminated
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 10 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 50 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 9, 2019
- Primary completion
- Jun 4, 2022
- Completion
- Jun 4, 2022
- Last update posted
- May 11, 2023
2019 – 2022
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| James Graham Brown Cancer Center at the University of Louisville | Louisville | Kentucky | 40202 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04088435, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 11, 2023 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04088435 live on ClinicalTrials.gov.