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NCT04088435 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by University of Louisville.

Terminated
Registry status
10
Enrollment target

NCT04088435 is a clinical trial that was terminated before completion, run by University of Louisville. The registered enrollment target is 10 participants.

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The verdict

NCT04088435 was terminated before completion, sponsored by University of Louisville.

TERMINATED
Registry status
10 participants
Enrollment target

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.

Interventions

  • RADIATION Intraoperative radiotherapy

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2019-09-10
Est. Completion 2022-06-05

Sponsor

University of Louisville

217 total trials

What the Registry Record Tells You About NCT04088435

The ClinicalTrials.gov registry entry for NCT04088435 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Louisville, which has 217 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Intraoperative radiotherapy is the first listed.

NCT04088435 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04088435 about?

NCT04088435 is a clinical study titled "Xoft® Intraoperative Radiotherapy (IORT) for Patients With Early-Stage Breast Cancer". 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 ...

What is the current status of trial NCT04088435?

This trial is currently terminated. The enrollment target is 10 participants. The study started on 2019-09-10. Estimated completion is 2022-06-05.

What interventions are being tested in trial NCT04088435?

The interventions under investigation include: Intraoperative radiotherapy (RADIATION).

Who is sponsoring clinical trial NCT04088435?

This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.