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NCT05387915 · ClinicalTrials.gov registry record · Phase 2
Biomarker-Driven Radiation Therapy Dose Reduction After Transoral Robotic Surgery for the Treatment of HPV-Positive Oropharyngeal Cancer
A Phase 2 study of Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and Oropharyngeal HPV-Positive Squamous Cell Carcinoma, sponsored by Emory University.
- Active
- Registry status
- Phase 2
- Development phase
- 33
- Enrollment target
- 3
- Study locations
NCT05387915: Active Phase 2 study of Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and Oropharyngeal HPV-Positive Squamous Cell Carcinoma, sponsored by Emory University.
NCT05387915 is a Phase 2 study of Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and Oropharyngeal HPV-Positive Squamous Cell Carcinoma that is active but no longer recruiting, run by Emory University. The registered enrollment target is 33 participants, below the 184-participant average among 9 other Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 trials with a reported enrollment target (82% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05387915, a Phase 2 study of Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and Oropharyngeal HPV-Positive Squamous Cell Carcinoma, is active but no longer recruiting, sponsored by Emory University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 33 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase II trial tests whether reduced dose radiation therapy after transoral robotic surgery works in treating patients with human papillomavirus (HPV)-positive oropharyngeal cancer. HPV positive oropharyngeal cancer has a better prognosis than oropharyngeal cancer not caused by HPV. A standard of care treatment for HPV positive oropharyngeal cancer is transoral robotic surgery followed by radiation therapy. However, this treatment is associated with many long-term side effects including difficulty swallowing. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving reduced dose radiation therapy after transoral robotic surgery may improve swallowing outcomes and quality of life compared to standard of care dose radiation therapy after transoral robotic surgery.
Primary Outcome
Will be assessed by the MD Anderson Dysphagia Index (MDADI) composite score (range 20 - 100, higher is better). Mean MDADI composite score will be reported at one year, along with a 95% confidence interval for the mean.
Conditions Studied
Interventions
- RADIATION Radiation Therapy
Study Locations (3)
Georgia
- Emory University Midtown Hospital - Atlanta
- Emory University Hospital/Winship Cancer Institute - Atlanta
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2022-06-06 |
| Est. Completion | 2026-05-05 |
| Phase | Phase 2 |
What the registry record for NCT05387915 still lists
NCT05387915 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 184-participant average among 9 other Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 trials with a reported enrollment target (82% lower).
The record links to 2 conditions, with Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 appearing as the primary indexed condition, and to 1 intervention - of which Radiation Therapy is the first listed.
NCT05387915 reports a single indexed study location in Georgia, Tennessee.
Frequently Asked Questions
What is clinical trial NCT05387915 about?
NCT05387915 is a clinical study titled "Biomarker-Driven Radiation Therapy Dose Reduction After Transoral Robotic Surgery for the Treatment of HPV-Positive Oropharyngeal Cancer". This phase II trial tests whether reduced dose radiation therapy after transoral robotic surgery works in treating patients with human papillomavirus (HPV)-positive oropharyngeal cancer. HPV positive oropharyngeal cancer has a better prognosis than oropharyngeal cancer not caused by HPV. A standard ...
What is the current status of trial NCT05387915?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2022-06-06. Estimated completion is 2026-05-05.
What conditions does trial NCT05387915 study?
This clinical trial studies the following conditions: Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Oropharyngeal HPV-Positive Squamous Cell Carcinoma.
What interventions are being tested in trial NCT05387915?
The interventions under investigation include: Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT05387915?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05387915 being conducted?
This trial has 3 study locations across Georgia, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05387915's enrollment target sits among peer trials
33 8th of 9 higher than 2 of 9 other Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 trials
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Each bar is a band; taller bars hold more other Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 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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