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NCT04883281 · ClinicalTrials.gov registry record · Phase 2
A Prospective Study of Daily Adaptive Radiotherapy to Better Organ-at-Risk Doses in Head and Neck Cancer
A Phase 2 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT04883281: Completed Phase 2 study, sponsored by University of Texas Southwestern Medical Center.
NCT04883281 is a Phase 2 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04883281, a Phase 2 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
Varian Medical Systems has recently deployed a completely novel radiation treatment system called EthosTM, a first-of-its-kind system that allows for daily adapative radiotherapy (DART), such that the treatment for that day can be created on-the-fly based on the patient's current positioning and anatomy. This system is commercially-available and FDA-approved, and UTSW Radiation Oncology has installed two such units. The ability to adjust the dose delivery every day means both that adaptive therapy is possible with every fraction and that the PTV margin can be dramatically reduced/eliminated, since investigators are treating for that day's patient setup. Investigators are therefore proposing a randomized trial using DART with near marginless (ML) setup margins (a 1 mm margin will be retained for intrafractional motion).
Primary Outcome
1-year score on the Xerostomia Questionnaire (XQ) to determine the difference in chronic xerostomia between patients treated with conventional INRT versus ML DART INRT. The XQ score at one year will be compared between the arms using a two-sided t test.
Interventions
- RADIATION Intensity modulated radiation therapy (IMRT) with or without chemotherapy
- DRUG cisplatin, cetuximab, or carboplatin-paclitaxel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2022-02-23 |
| Est. Completion | 2026-03-11 |
| Phase | Phase 2 |
What the finished NCT04883281 record still lists
NCT04883281 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which Intensity modulated radiation therapy (IMRT) with or without chemotherapy is the first listed.
NCT04883281 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04883281 about?
NCT04883281 is a clinical study titled "A Prospective Study of Daily Adaptive Radiotherapy to Better Organ-at-Risk Doses in Head and Neck Cancer". Varian Medical Systems has recently deployed a completely novel radiation treatment system called EthosTM, a first-of-its-kind system that allows for daily adapative radiotherapy (DART), such that the treatment for that day can be created on-the-fly based on the patient's current positioning and ana...
What is the current status of trial NCT04883281?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2022-02-23. Estimated completion is 2026-03-11.
What interventions are being tested in trial NCT04883281?
The interventions under investigation include: Intensity modulated radiation therapy (IMRT) with or without chemotherapy (RADIATION), cisplatin, cetuximab, or carboplatin-paclitaxel (DRUG).
Who is sponsoring clinical trial NCT04883281?
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 NCT04883281's enrollment target sits among peer trials
50 1195th of 2000 higher than 740 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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