Robotic Surgery for HPV-related Oropharyngeal Cancer
This study is investigating if robotic surgery alone can effectively treat HPV-related oropharyngeal squamous cell carcinoma (a type of throat cancer linked to the human papillomavirus). The researchers are looking at patients who have had their tumor removed by transoral robotic surgery (TORS) and whose blood tests show no HPV circulating tumor DNA (cfHPVDNA) after surgery. The goal is to see if this approach can control the cancer and help patients live as long as those who receive standard treatments, but with fewer side effects from chemotherapy and radiation. To join, you must be an adult with HPV-positive oropharyngeal squamous cell carcinoma that can be removed by surgery. The study will measure if the cancer returns in the treated area or nearby lymph nodes within two years.
- Study design
- This is an interventional study with a planned enrollment of 83 participants. It is not specified if the study is randomized or blinded.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for local and/or regional disease recurrence for two years after treatment.
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NCT05419089
The Sinai Robotic Surgery Trial in HPV-related Oropharyngeal Squamous Cell Carcinoma (SIRS 2.0 Trial)
Recruiting
PHASE2Ages 18+InterventionalTreatmentIcahn School of Medicine at Mount SinaiInvestigator-initiated
~83 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:Robotic surgery
At a glance
Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Local and/or regional disease recurrence (LRR)
Measured over 2 years
Conditions
Where it's being run
2 sites across 2 statesNew Jersey1
New York1
Study leadership
- Raymond Chai · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Patients must have histologically or cytologically confirmed and identified resectable primary OPSCC with positive p16 immunohistochemistry, defined as strong and diffuse nuclear and cytoplasmic staining in \> 70% of tumor cells. Immunohistochemistry must be performed or reviewed at the central laboratory. P16 status may be determined prior to consent and must be confirmed by surgical specimen if a biopsy is unavailable. HR-HPV status and postoperative cfHPVDNA testing must be performed and resulted prior to treatment assignment. Tissue from the primary site must be available for biomarker studies after surgery.
Patients enrolled in the trial must have pre-surgery baseline cfHPVDNA using the NavDX assay (Naveris, Cambridge, MA). Detectable baseline cfHPVDNA copy number is defined as ≥ 10 fragments/mL and is required for inclusion in the trial.
Undetectable cfHPVDNA after surgery. All patients should have a repeat cfHPVDNA test within 1 to 5 weeks post-operatively and prior to treatment assignment. Undetectable cfHPVDNA is defined as \< 5 fragments/mL.
AJCC 7th edition early and intermediate stage (T1N0-2B, T2N0-2B) (non-matted) disease without evidence of distant metastases or gross extranodal extension.
Age ≥ 18 years at screening
No previous surgery, radiation therapy, or chemotherapy 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.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
No active tobacco use (≥1cigarette or cigarette-equivalent per day within the last 5 years) and no cumulative smoking history of \>20 pack years. 1 cigar = 4 cigarette-equivalent exposure
Ability to understand and the willingness to sign a written informed consent document.
Participants must have adequate bone marrow, hepatic and renal functions as defined below:
Platelet count ≥ 90 x 109/l.
Hemoglobin ≥ 10 g/dl (may achieve by transfusion).
Renal function: eGFR ≥ 50 ml/min
Exclusion
Age \< 18 years at screening
Pregnant or breast-feeding women.
Previous or current malignancies at other sites, except for adequately treated in situ carcinoma of the cervix, basal or squamous cell carcinoma of the skin, thyroid cancer, prostate cancer treated with surgery/radiotherapy, ductal carcinoma in situ of the breast treated with surgery/radiotherapy, or other cancer curatively treated and with no current evidence of disease for at least 3 years.
Other serious illnesses or medical conditions including but not limited to:
Unstable cardiac disease despite treatment or myocardial infarction within 6 months prior to study entry.
History of significant neurologic or psychiatric disorders including severe dementia or poorly controlled seizures
Active clinically significant uncontrolled infection
Active peptic ulcer disease defined as unhealed or clinically active
Active drug addiction including alcohol, cocaine or intravenous drug use defined as occurring within the 6 months preceding diagnosis
Severe chronic obstructive pulmonary disease, defined as being associated with a hospitalization for pneumonia within 12 months of diagnosis.
Prior organ transplant
Interstitial lung disease
Concurrent treatment with any other anti-cancer therapy
Participation in an investigational therapeutic drug trial within 30 days of study entry. Participation in additional investigational radiation studies will exclude participation in SIRS. Participation in non-therapeutic, non-oncologic investigational studies (i.e. pain control studies, nutritional studies, etc.) will be allowed amongst SIRS participants, provided there is no alteration of treatment planning, oncologic therapy, or surveillance, and additional studies comply with SIRS safety criteria and stopping rules as outlined in the SIRS protocol.
Active hepatitis C by history
Advanced nodal stage (AJCC 7th edition N2C, N3) or surgically unresectable disease or disease that cannot be fully resected, unequivocal radiographic extranodal extension, unequivocal radiographic or clinical supraclavicular or matted metastatic disease, \> 3 unequivocally radiographic pathologic cervical nodes.
Non-HR-HPV subtype on initial biopsy or final pathology.
5 or more positive nodes, irrespective of size, on final pathology.
p16 or HPV negative OPSCC as determined by IHC and PCR or ISH, respectively.
Undetectable or \< 10 fragments/mL baseline cfHPVDNA prior to surgery.
Autoimmune disease treated with chemotherapy agents or anti TNF agents within the last 2 years.
Detectable repeat cfHPVDNA 1-5 weeks postoperatively via the NavDX assay, defined as \> 5 fragments/mL.
What this trial measures
- Local and/or regional disease recurrence (LRR)2 years
Local and/or regional disease recurrence (LRR) at 2 years