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NCT04477759 · ClinicalTrials.gov registry record · Phase 1
Dose-Escalated Hypofractionated Adaptive Radiotherapy for Head and Neck Cancer
A Phase 1 study of Head and Neck Neoplasm, sponsored by Medical College of Wisconsin.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT04477759: Completed Phase 1 study of Head and Neck Neoplasm, sponsored by Medical College of Wisconsin.
NCT04477759 is a Phase 1 study of Head and Neck Neoplasm that has completed, run by Medical College of Wisconsin. The registered enrollment target is 18 participants, below the 175-participant average among 3 other Head and Neck Neoplasm trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04477759, a Phase 1 study of Head and Neck Neoplasm, has completed, sponsored by Medical College of Wisconsin.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
Locoregional failure remains the principal mode of mortality in head and neck squamous cell carcinoma (HNSCC) treated with conventional chemoradiation therapy. Magnetic resonance-guided radiation therapy (MRgRT) allows for adaptive radiation dose escalation based on tumor response and may improve therapeutic outcomes while limiting toxicities. This protocol evaluates a novel framework for radiation delivery with concurrent atezolizumab in patients with advanced HNSCC. Dose-Escalated Hypofractionated Adaptive Radiotherapy (DEHART) modifies radiation dose using MRgRT by escalating radiation dose to residual tumor while deescalating radiation dose to areas of tumor regression.
Primary Outcome
This measure is the number of subjects experiencing a dose-limiting toxicity. A dose-limiting toxicity is defined as an inability to complete radiation treatment within 30 days of the start of radiotherapy that is not deemed to be related to disease progression; OR an unacceptable toxicity within one year of treatment (Grade 4+ toxicity) that is probably or definitely related to radiation treatment as determined by the treating physician or a death within one year of treatment that is probably o
Conditions Studied
Interventions
- RADIATION 50 Gy Radiation Therapy
- RADIATION 55 Gy Radiation Therapy
- RADIATION 60 Gy Radiation Therapy
- DRUG Concurrent Atezolizumab
- DRUG Adjuvant Atezolizumab
Study Locations (1)
Wisconsin
- Froedtert & Medical College of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2021-01-26 |
| Est. Completion | 2025-04-14 |
| Phase | Phase 1 |
What the finished NCT04477759 record still lists
NCT04477759 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 175-participant average among 3 other Head and Neck Neoplasm trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Head and Neck Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which 50 Gy Radiation Therapy is the first listed.
NCT04477759 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT04477759 about?
NCT04477759 is a clinical study titled "Dose-Escalated Hypofractionated Adaptive Radiotherapy for Head and Neck Cancer". Locoregional failure remains the principal mode of mortality in head and neck squamous cell carcinoma (HNSCC) treated with conventional chemoradiation therapy. Magnetic resonance-guided radiation therapy (MRgRT) allows for adaptive radiation dose escalation based on tumor response and may improve th...
What is the current status of trial NCT04477759?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2021-01-26. Estimated completion is 2025-04-14.
What conditions does trial NCT04477759 study?
This clinical trial studies the following conditions: Head and Neck Neoplasm.
What interventions are being tested in trial NCT04477759?
The interventions under investigation include: 50 Gy Radiation Therapy (RADIATION), 55 Gy Radiation Therapy (RADIATION), 60 Gy Radiation Therapy (RADIATION), Concurrent Atezolizumab (DRUG), Adjuvant Atezolizumab (DRUG).
Who is sponsoring clinical trial NCT04477759?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04477759 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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