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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 is a Phase 2 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 50 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04883281
The ClinicalTrials.gov registry entry for NCT04883281 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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