Actively Recruiting
The Sinai Robotic Surgery Trial in HPV-related Oropharyngeal Squamous Cell Carcinoma (SIRS 2.0 Trial)
Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-06-13
83
Participants Needed
2
Research Sites
255 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Sinai Robotic Surgery Trial in HPV-related Oropharyngeal Squamous Cell Carcinoma (SIRS 2.0 Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed resectable primary oropharyngeal squamous cell carcinoma with positive p16 immunohistochemistry (>70% tumor cells stained).
- Positive high-risk HPV DNA or RNA detected before surgery.
- Detectable baseline cfHPVDNA (≥10 fragments/mL) before surgery.
- Undetectable cfHPVDNA (<5 fragments/mL) within 1 to 5 weeks after surgery.
- AJCC 7th edition early to intermediate stage disease (T1N0-2B, T2N0-2B) without distant metastases or gross extranodal extension.
- Age 18 years or older at screening.
- No prior surgery, radiation, or chemotherapy for head and neck cancer except biopsy or tonsillectomy.
- ECOG performance status of 0 or 1.
- No active tobacco use (≥1 cigarette per day) in the last 5 years and less than 20 pack years total tobacco exposure.
- Ability and willingness to provide informed consent.
- Adequate bone marrow, liver, and kidney function as defined by platelet count ≥90 x 10^9/L, hemoglobin ≥10 g/dL, and eGFR ≥50 mL/min.
You will not qualify if you...
- Younger than 18 years at screening.
- Pregnant or breastfeeding women.
- Previous or current cancers at other sites except certain treated and disease-free cancers for at least 3 years.
- Serious medical conditions such as unstable heart disease, recent heart attack, severe neurological or psychiatric disorders, active infections, active peptic ulcer disease, recent drug addiction, severe COPD with recent hospitalization, prior organ transplant, or interstitial lung disease.
- Concurrent anti-cancer therapy or recent participation in another investigational therapeutic drug trial.
- Active hepatitis C infection.
- Advanced nodal stage (N2C or N3) or unresectable disease.
- More than three pathologic cervical nodes or more than four positive nodes in total.
- Non-high-risk HPV subtype or negative p16 or HPV status.
- Undetectable or low baseline cfHPVDNA (<10 fragments/mL) before surgery.
- Autoimmune disease treated with chemotherapy or anti-TNF agents in the last 2 years.
- Detectable cfHPVDNA (>5 fragments/mL) after surgery.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Valley - Mount Sinai Comprehensive Cancer Care
Paramus, New Jersey, United States, 07652
Actively Recruiting
2
Mount Sinai Health System
New York, New York, United States, 10019
Actively Recruiting
Research Team
M
Mabel Korley
CONTACT
C
Chanel Rojas
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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