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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: Clinical Trial study, sponsored by University of Louisville.
NCT04088435 is a clinical trial that was terminated before completion, run by University of Louisville. The registered enrollment target is 10 participants. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Adverse side effects of radiation grade 2 or higher as per CTCAE version 5.0
Interventions
- RADIATION Intraoperative radiotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2019-09-10 |
| Est. Completion | 2022-06-05 |
Why NCT04088435 stopped before completion
NCT04088435 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 10 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Intraoperative radiotherapy is the first listed.
NCT04088435 does not publish any study locations in the registry export this page uses.
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.
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