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NCT05053737 · ClinicalTrials.gov registry record · Phase 1
Radiotherapy in Combination With Atezolizumab Prior to Surgical Resection for HPV Unrelated HNSCC
A Phase 1 study of Squamous Cell Carcinoma of Head and Neck, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
- 4
- Study locations
NCT05053737: Completed Phase 1 study of Squamous Cell Carcinoma of Head and Neck, sponsored by University of Colorado, Denver.
NCT05053737 is a Phase 1 study of Squamous Cell Carcinoma of Head and Neck that has completed, run by University of Colorado, Denver. The registered enrollment target is 11 participants, below the 170-participant average among 37 other Squamous Cell Carcinoma of Head and Neck trials with a reported enrollment target (94% lower). The trial reports 4 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05053737, a Phase 1 study of Squamous Cell Carcinoma of Head and Neck, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
- 4
- Study locations
Study Summary
To determine the outcomes of patients with specific head and neck cancer after undergoing radiation therapy with atezolizumab followed by surgery then radiation with or without chemotherapy according to national guidelines.
Primary Outcome
Phase I lead in: the primary endpoint will be the binary outcome of whether or not a patient experiences the occurrence of a dose-limiting toxicity (DLT). Adverse events will be reviewed for safety assessments.
Conditions Studied
Interventions
- DRUG Atezolizumab
- RADIATION Stereotactic Body Radiation Therapy
Study Locations (4)
Colorado
- Colorado Research Center - Aurora
- Memorial Health Central - Colorado Springs
- Memorial Hospital North - Colorado Springs
- Highlands Ranch Hospital - Highlands Ranch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2021-11-02 |
| Est. Completion | 2024-06-21 |
| Phase | Phase 1 |
What the finished NCT05053737 record still lists
NCT05053737 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 170-participant average among 37 other Squamous Cell Carcinoma of Head and Neck trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Squamous Cell Carcinoma of Head and Neck appearing as the primary indexed condition, and to 2 interventions - of which Atezolizumab is the first listed.
NCT05053737 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT05053737 about?
NCT05053737 is a clinical study titled "Radiotherapy in Combination With Atezolizumab Prior to Surgical Resection for HPV Unrelated HNSCC". To determine the outcomes of patients with specific head and neck cancer after undergoing radiation therapy with atezolizumab followed by surgery then radiation with or without chemotherapy according to national guidelines.
What is the current status of trial NCT05053737?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2021-11-02. Estimated completion is 2024-06-21.
What conditions does trial NCT05053737 study?
This clinical trial studies the following conditions: Squamous Cell Carcinoma of Head and Neck.
What interventions are being tested in trial NCT05053737?
The interventions under investigation include: Atezolizumab (DRUG), Stereotactic Body Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT05053737?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05053737 being conducted?
This trial has 4 study locations across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05053737's enrollment target sits among peer trials
11 34th of 37 higher than 3 of 37 other Squamous Cell Carcinoma of Head and Neck trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Squamous Cell Carcinoma of Head and Neck 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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