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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 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.

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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.

Conditions Studied

HPV Positive Oropharyngeal Squamous Cell Carcinoma

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

FieldValue
Enrollment Target 83 participants
Start Date 2022-07-12
Est. Completion 2027-06
Phase Phase 2

Sponsor

Icahn School of Medicine at Mount Sinai

708 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05419089

The ClinicalTrials.gov registry entry for NCT05419089 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 83 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 87-participant average among 16 other HPV Positive Oropharyngeal Squamous Cell Carcinoma trials with a reported enrollment target. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.