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Xoft® Intraoperative Radiotherapy (IORT) for Patients With Early-Stage Breast Cancer

NCT04088435 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2023-05-12

No results posted yet for this study

Summary

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.

Conditions

  • Breast Cancer
  • Breast Cancer, Invasive Ductal
  • Invasive Mammary Carcinoma
  • Breast Cancer Stage I
  • Breast Cancer Stage IIA

Interventions

RADIATION

Intraoperative radiotherapy

The IORT component of this treatment is being delivered as per standard clinical practice. 20 Gy in one fraction will be delivered at the time of lumpectomy.

Sponsors & Collaborators

  • University of Louisville

    lead OTHER

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-10
Primary Completion
2022-06-05
Completion
2022-06-05

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04088435 on ClinicalTrials.gov