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NCT03561454 · ClinicalTrials.gov registry record
A Registry of Intra-Operative Radiation Therapy (IORT) Using the Xoft ® Axxent ® eBx ™ System Patients
A clinical trial of Early Stage Breast Cancer, sponsored by MedStar Franklin Square Medical Center.
- Active
- Registry status
- 100
- Enrollment target
- 1
- Study location
NCT03561454: Active study of Early Stage Breast Cancer, sponsored by MedStar Franklin Square Medical Center.
NCT03561454 is a study of Early Stage Breast Cancer that is active but no longer recruiting, run by MedStar Franklin Square Medical Center. The registered enrollment target is 100 participants, below the 409-participant average among 21 other Early Stage Breast Cancer trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03561454, a study of Early Stage Breast Cancer, is active but no longer recruiting, sponsored by MedStar Franklin Square Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
Single arm, prospective, multi-center, non-randomized study of subjects treated with single fraction, intra-operative radiation therapy at the time of lumpectomy for early stage breast cancer.To assess the rate of ipsilateral breast tumor recurrence in subjects treated with the Xoft Axxent Electronic Brachytherapy System when used for single-fraction, intra-operative radiation therapy treatment of early stage breast cancer when compared to whole breast irradiation (WBI) at 5 years of follow-up. The results of this single arm study will be compared to whole breast irradiation (WBI).
Conditions Studied
Interventions
- DEVICE IORT
Study Locations (1)
Maryland
- MedStar Good Samaritan Hospital - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2019-01-11 |
| Est. Completion | 2029-08-01 |
What the registry record for NCT03561454 still lists
NCT03561454 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 409-participant average among 21 other Early Stage Breast Cancer trials with a reported enrollment target (76% lower).
The record links to 1 condition, with Early Stage Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which IORT is the first listed.
NCT03561454 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03561454 about?
NCT03561454 is a clinical study titled "A Registry of Intra-Operative Radiation Therapy (IORT) Using the Xoft ® Axxent ® eBx ™ System Patients". Single arm, prospective, multi-center, non-randomized study of subjects treated with single fraction, intra-operative radiation therapy at the time of lumpectomy for early stage breast cancer.To assess the rate of ipsilateral breast tumor recurrence in subjects treated with the Xoft Axxent Electroni...
What is the current status of trial NCT03561454?
This trial is currently active not recruiting. The enrollment target is 100 participants. The study started on 2019-01-11. Estimated completion is 2029-08-01.
What conditions does trial NCT03561454 study?
This clinical trial studies the following conditions: Early Stage Breast Cancer.
What interventions are being tested in trial NCT03561454?
The interventions under investigation include: IORT (DEVICE).
Who is sponsoring clinical trial NCT03561454?
This trial is sponsored by MedStar Franklin Square Medical Center, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03561454 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Early Stage Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03561454's enrollment target sits among peer trials
100 7th of 21 higher than 14 of 21 other Early Stage Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Stage Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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