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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Primary and study completion dates: Jun 2027 to Jun 2029v11
  2. Site contacts updated at 1 of 2 sitesv10
  3. Enrollment target: 74 to 83
    • Eligibility criteria shortened, about 20 words
    v9
  4. Enrollment target: 199 to 74v8 Show 5 more changesShow less
    • Interventions: Cisplatin (Drug), De-intensified XRT (Radiation), Robotic surgery (Procedure) to Robotic surgery (Procedure)
    • Eligibility criteria expanded, about 384 words
    • Study description expanded, about 51 words
    • Site contacts updated at 1 of 2 sites
    • Study arms: 2 to 1
  5. Re-verified, no change to tracked fieldsv7
Show 5 earlier versionsHide 5 earlier versions
  1. Study sites: 1 to 2
    • Eligibility criteria shortened, about 3 words
    v6
  2. Eligibility criteria revised
    • Site contact updated
    v5
  3. Eligibility criteria expanded, about 22 wordsv4
  4. Eligibility criteria expanded, about 19 words
    • Study description revised
    v3
  5. Start date changed from estimate of Jun 2022 to Jul 12, 2022v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05419089
Lead Sponsor Icahn School of Medicine at Mount Sinai
Conditions
(from sponsor)		 HPV-positive Oropharyngeal Squamous Cell Carcinoma
Related terms Squamous Cell Carcinoma of Head and Neck
Enrollment 83 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov