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NCT05419089 · ClinicalTrials.gov registry record · Phase 2
The Sinai Robotic Surgery Trial in HPV-related Oropharyngeal Squamous Cell Carcinoma (SIRS 2.0 Trial)
A Phase 2 study of HPV Positive Oropharyngeal Squamous Cell Carcinoma, sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 83
- Enrollment target
- 2
- Study locations
NCT05419089: Recruiting Phase 2 study of HPV Positive Oropharyngeal Squamous Cell Carcinoma, sponsored by Icahn School of Medicine at Mount Sinai.
NCT05419089 is a Phase 2 study of HPV Positive Oropharyngeal Squamous Cell Carcinoma that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 83 participants, roughly in line with the 87-participant average among 16 other HPV Positive Oropharyngeal Squamous Cell Carcinoma trials with a reported enrollment target. The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05419089, a Phase 2 study of HPV Positive Oropharyngeal Squamous Cell Carcinoma, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 83 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to determine whether treatment of HPV-related oropharyngeal squamous cell carcinoma in patients with undetectable postoperative HPV circulating tumor DNA (cfHPVDNA) with transoral robotic surgery (TORS) alone can result in cancer control and survival comparable to those previously reported with standard therapy. The protocol includes patients with only with low or intermediate pathologic risk factors following surgery with detectable pre-surgery cfHPVDNA and undetectable post-surgery cfHPVDNA. The hope is that with this approach, the long-term complications from chemotherapy and radiation can be reduced.
Primary Outcome
Local and/or regional disease recurrence (LRR) at 2 years
Conditions Studied
Interventions
- PROCEDURE Robotic surgery
Study Locations (2)
New Jersey
- Valley - Mount Sinai Comprehensive Cancer Care - Paramus
New York
- Mount Sinai Health System - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2022-07-12 |
| Est. Completion | 2027-06 |
| Phase | Phase 2 |
What NCT05419089 shows while recruiting
NCT05419089 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, roughly in line with the 87-participant average among 16 other HPV Positive Oropharyngeal Squamous Cell Carcinoma trials with a reported enrollment target.
The record links to 1 condition, with HPV Positive Oropharyngeal Squamous Cell Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which Robotic surgery is the first listed.
NCT05419089 reports a single indexed study location in New Jersey, New York.
Frequently Asked Questions
What is clinical trial NCT05419089 about?
NCT05419089 is a clinical study titled "The Sinai Robotic Surgery Trial in HPV-related Oropharyngeal Squamous Cell Carcinoma (SIRS 2.0 Trial)". The purpose of this study is to determine whether treatment of HPV-related oropharyngeal squamous cell carcinoma in patients with undetectable postoperative HPV circulating tumor DNA (cfHPVDNA) with transoral robotic surgery (TORS) alone can result in cancer control and survival comparable to those ...
What is the current status of trial NCT05419089?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 83 participants. The study started on 2022-07-12. Estimated completion is 2027-06.
What conditions does trial NCT05419089 study?
This clinical trial studies the following conditions: HPV Positive Oropharyngeal Squamous Cell Carcinoma.
What interventions are being tested in trial NCT05419089?
The interventions under investigation include: Robotic surgery (PROCEDURE).
Who is sponsoring clinical trial NCT05419089?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05419089 being conducted?
This trial has 2 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HPV Positive Oropharyngeal Squamous Cell Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05419089's enrollment target sits among peer trials
83 8th of 16 higher than 8 of 16 other HPV Positive Oropharyngeal Squamous Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HPV Positive Oropharyngeal Squamous Cell Carcinoma 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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