RecruitingPhase 2NCT05419089

The Sinai Robotic Surgery Trial in HPV-related Oropharyngeal Squamous Cell Carcinoma (SIRS 2.0 Trial)

Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

83 participants

Start Date

Jul 12, 2022

Study Type

INTERVENTIONAL

Conditions

HPV Positive Oropharyngeal Squamous Cell Carcinoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a surgical approach using robotic technology to remove throat cancers (oropharyngeal squamous cell carcinoma) that are linked to HPV (human papillomavirus). The goal is to see whether surgery-first can allow doctors to reduce or eliminate the need for radiation and chemotherapy afterward, reducing long-term side effects. **You may be eligible if...** - You have been diagnosed with oropharyngeal cancer (back of the throat, tonsils, base of tongue) - Your tumor is HPV-related (confirmed positive for p16 protein) - Your cancer is considered surgically removable (resectable) - You are 18 or older and in adequate health to undergo surgery **You may NOT be eligible if...** - Your cancer has spread to distant organs - Your tumor has grown into major blood vessels or other structures making surgery unsafe - You have had prior radiation to the head and neck - You are pregnant - Your overall health is too poor to undergo surgery or general anesthesia Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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