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 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 c

Trial Details

NCT ID
NCT05419089
Phase
PHASE2
Sponsor
Icahn School of Medicine at Mount Sinai
Status
RECRUITING
Cancer Type
Head and Neck Cancer
Interventions
  • Robotic surgery
Locations (sample)
  • Paramus, New Jersey, United States|40.94454,-74.07542
  • New York, New York, United States|40.71427,-74.00597

Key Eligibility Criteria

  • Patients must have histologically or cytologically confirmed and identified resectable primary OPSCC with positive p16 immunohistochemistry, define…
  • Patients enrolled in the trial must have pre-surgery baseline cfHPVDNA using the NavDX assay (Naveris, Cambridge, MA). Detectable baseline cfHPVDNA…
  • Undetectable cfHPVDNA after surgery. All patients should have a repeat cfHPVDNA test within 1 to 5 weeks post-operatively and prior to treatment as…
  • AJCC 7th edition early and intermediate stage (T1N0-2B, T2N0-2B) (non-matted) disease without evidence of distant metastases or gross extranodal ex…

For full eligibility, visit ClinicalTrials.gov.

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