OncoMatch/Clinical Trials/NCT05419089
The Sinai Robotic Surgery Trial in HPV-related Oropharyngeal Squamous Cell Carcinoma (SIRS 2.0 Trial)
Is NCT05419089 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies non-drug interventions for hpv-positive oropharyngeal squamous cell carcinoma.
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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: CDKN2A p16 overexpression (strong and diffuse nuclear and cytoplasmic staining in > 70% of tumor cells)
positive p16 immunohistochemistry, defined as strong and diffuse nuclear and cytoplasmic staining in > 70% of tumor cells
Required: HPV high-risk subtype
HR-HPV status ... Non-HR-HPV subtype on initial biopsy or final pathology [excluded]
Required: HPV detectable cfHPVDNA (baseline, pre-surgery) (≥ 10 fragments/mL)
Detectable baseline cfHPVDNA copy number is defined as ≥ 10 fragments/mL and is required for inclusion in the trial
Required: HPV undetectable cfHPVDNA (post-surgery) (< 5 fragments/mL)
Undetectable cfHPVDNA after surgery. ... Undetectable cfHPVDNA is defined as < 5 fragments/mL
Excluded: HPV negative
HPV negative OPSCC as determined by ... PCR or ISH, respectively
Excluded: CDKN2A p16 negative
p16 ... negative OPSCC as determined by IHC
Excluded: HPV detectable cfHPVDNA (post-surgery)
Detectable repeat cfHPVDNA 1-5 weeks postoperatively via the NavDX assay, defined as > 5 fragments/mL
Excluded: HPV undetectable or < 10 fragments/mL baseline cfHPVDNA prior to surgery
Undetectable or < 10 fragments/mL baseline cfHPVDNA prior to surgery
Disease stage
Required: Stage AJCC 7TH EDITION T1N0-2B, T2N0-2B (AJCC 7th edition)
Excluded: Stage N2C
AJCC 7th edition early and intermediate stage (T1N0-2B, T2N0-2B) (non-matted) disease without evidence of distant metastases or gross extranodal extension
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: surgery
Exception: excision/incisional biopsy of the primary site, excisional/incisional nodal biopsy, or tonsillectomy
No previous surgery ... for head and neck cancer (other than excision/incisional biopsy of the primary site, excisional/incisional nodal biopsy, or tonsillectomy) is allowed at time of study entry
Cannot have received: radiation therapy
No previous ... radiation therapy ... for head and neck cancer ... is allowed at time of study entry
Cannot have received: chemotherapy
No previous ... chemotherapy for head and neck cancer ... is allowed at time of study entry
Lab requirements
Blood counts
Platelet count ≥ 90 x 10^9/l; Hemoglobin ≥ 10 g/dl (may achieve by transfusion)
Kidney function
eGFR ≥ 50 ml/min
Liver function
adequate bone marrow, hepatic and renal functions as defined below: Platelet count ≥ 90 x 10^9/l. Hemoglobin ≥ 10 g/dl (may achieve by transfusion). Renal function: eGFR ≥ 50 ml/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Valley - Mount Sinai Comprehensive Cancer Care · Paramus, New Jersey
- Mount Sinai Health System · New York, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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