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NCT03953976 · ClinicalTrials.gov registry record · Phase 2
INRT-AIR: A Prospective Phase II Study of Involved Nodal Radiation Therapy
A Phase 2 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 67
- Enrollment target
NCT03953976: Completed Phase 2 study, sponsored by University of Texas Southwestern Medical Center.
NCT03953976 is a Phase 2 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 67 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03953976, a Phase 2 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 67 participants
- Enrollment target
Study Summary
Elective nodal irradiation has been a longstanding standard-of-care in the management of mucosal squamous cell carcinoma of the head and neck. Recent studies have suggested that reduced elective dose and volume may be a viable approach to improve toxicity. In this study, we are eliminating the elective neck treatment, focusing therapy on involved and suspicious nodes.
Primary Outcome
Definition: solitary means that the recurrence occurred without a preceding or synchronous in-field or distant recurrence By definition, local recurrence (LR) means disease recurrence in the primary site, and regional recurrence (RR) is a nodal failure anywhere in the neck. Patients who experienced either an LR or RR (or both), were also coded as a locoregional recurrence.
Interventions
- RADIATION Intensity modulated radiation therapy (IMRT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2019-07-23 |
| Est. Completion | 2024-01-22 |
| Phase | Phase 2 |
What the finished NCT03953976 record still lists
NCT03953976 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 1 intervention - of which Intensity modulated radiation therapy (IMRT) is the first listed.
NCT03953976 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03953976 about?
NCT03953976 is a clinical study titled "INRT-AIR: A Prospective Phase II Study of Involved Nodal Radiation Therapy". Elective nodal irradiation has been a longstanding standard-of-care in the management of mucosal squamous cell carcinoma of the head and neck. Recent studies have suggested that reduced elective dose and volume may be a viable approach to improve toxicity. In this study, we are eliminating the elect...
What is the current status of trial NCT03953976?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 67 participants. The study started on 2019-07-23. Estimated completion is 2024-01-22.
What interventions are being tested in trial NCT03953976?
The interventions under investigation include: Intensity modulated radiation therapy (IMRT) (RADIATION).
Who is sponsoring clinical trial NCT03953976?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03953976's enrollment target sits among peer trials
67 974th of 2000 higher than 1,026 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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