HPV-positive Oropharyngeal Squamous Cell CarcinomaPhase 2NCT05419089
The Sinai Robotic Surgery Trial in HPV-related Oropharyngeal Squamous Cell Carcinoma (SIRS 2.0 Trial)
A Phase 2 study testing Robotic surgery in people with HPV-positive Oropharyngeal Squamous Cell Carcinoma, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HPV-positive Oropharyngeal Squamous Cell Carcinoma
- What is being tested?
- Robotic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Jul 2022to Jun 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Mount Sinai Health System
New York, New York, 10019
Raymond Chai, MD
- Recruiting
Valley - Mount Sinai Comprehensive Cancer Care
Paramus, New Jersey, 07652
About this study
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.
Read the detailed description
There has been significant increase in the incidence of oropharynx cancer in North America and Europe. It is now understood that there are two dominant carcinogenic pathways for oropharyngeal squamous cell carcinoma. Environmentally related which is caused mainly by smoking and alcohol, and HPV-related oropharyngeal squamous cell carcinoma (HPVOPSCC). HPVOPSCC now accounts for over 80% of OPC seen in the USA and an increasing fraction of these malignancies in Europe. It has been shown that HPVOPSCC confers an excellent prognosis for intermediate staged disease and this has called into question the rational for aggressive concurrent chemoradiotherapy. High-dose radiotherapy (RT) and chemoradiotherapy (CRT) have substantial impact on local tissues and organ function and result in a significant rate of late mortality and morbidity. Studies are now being designed to reduce the impact of RT and CRT for patients.
Recently, a new test has been developed that measures HPV circulating tumor DNA (cfHPVDNA) in the blood. The test has emerged as a promising biomarker for HPVOPSCC, correlating with both treatment response as well as surveillance for cancer recurrence. Data suggests that a negative test in the surveillance period following treatment is highly sensitive and specific for recurrent disease.
In this trial, the study will be stratifying p16 positive patients with PCR detectable high-risk (HR) HPV DNA or RNA following TORS into risk groups based on final pathology to determine appropriate treatment intensity. Patients with low- or intermediate-risk pathologic disease and undetectable postoperative cfHPVDNA will receive no adjuvant therapy. This group includes patients with AJCC 7th edition T1-T2N0-2b disease. Patients must have less than four pathologic nodes on final pathology, negative margins, and no contralateral nodes. Perineural or lymphovascular alone is allowed but not in combination. Microscopic extranodal extension (less than or equal to 2 mm) is allowed. Patients cannot be active smokers or have a 20 or greater pack year history of smoking.
- Being tested
- Robotic surgery
- Keywords
- Oropharyngeal squamous cell carcinoma, OPSCC, Human papillomavirus, Transoral robotic surgery, TORS, HPV, p16, ctDNA, circulating tumor DNA, cfHPVDNA
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic surgeryProcedure or surgery
Transoral robotic surgical resection of the tumor with negative intraoperative frozen section margins.
| Study group | Role | What they receive |
|---|---|---|
| Robotic surgery only | Experimental | * Complete resection to negative frozen section margins (pT1-2)
* < 4 nodes, ≤ 2 mm extranodal extension (ENE), no supraclavicular nodes Receives: Procedure: Robotic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local and/or regional disease recurrence (LRR)
Local and/or regional disease recurrence (LRR) at 2 years
Measured: 2 years
Secondary outcomes (8)
Progression-free survival (PFS)
PFS at 2 years as defined as the proportion of patients without events (recurrence or death) at 2 years
Measured: 2 years
Disease free survival (DFS)
PFS at 2 years as defined as the proportion of patients without events (recurrence or death) at 2 years
Measured: 2 years
Overall Survival (OS)
OS at 2 years is defined as the proportion of patients alive at 2 years
Measured: 2 years
M.D. Anderson Dysphagia Inventory
20 items instrument: a global assessment (a single question), it comprises three subscales: the emotional subscale (8 items), the functional subscale (5 items), and the physical subscale (6 items). The global assessment refers to the individual's swallowing difficulty as it affects one's overall daily routine. The emotional, functional, and physical subscales refer to the individual's affective response to the swallowing disorder, the impact of the disorder on daily activities, and the self-perception of the swallowing difficulties, respectively. Using a five-point scale (1-5), the minimum total score is 20 and the maximum 100. Higher score indicates the least interference with daily life.
Measured: 2 years
Xerostomia Questionnaire (XQ)
Scale range from 1-10 (1 being dry as a desert and 10 is normal). Higher score indicates better health outcomes
Measured: 2 years
European Organization of Research and Treatment Of Cancer (EORTC QLQ-C30)
EORTC QLQ-C30 is a 30-question tool used to assess the overall QoL in cancer participants. It consisted of 15 domains: 1 GHS/QoL scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). Most items are scored 1 ("not at all") to 4 ("very much") except for the items contributing to the GHS/QoL, which are scored 1 ("very poor") to 7 ("excellent"). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100. For the GHS/QoL and 5 functional scales a high score indicates better global health status/functioning and a negative change from baseline indicated less improvement. Scale ranges from 0-100. For the symptom scales, a high score indicates a higher level of symptoms, and a negative change from baseline indicated an improvement in symptoms.
Measured: 2 years
European Organization of Research and Treatment of Head and Neck cancer questionnaire (EORTC QLQ-H&N35)
EORTC QLQ-H\&N35 is a 35-question site-specific tool and is used in conjunction with EORTC QLQ-C30 measurement tool. Scale range from 0-100. Higher score indicates poorer health outcomes.
Measured: 2 years
M.D. Anderson Symptom Inventory - Head & Neck (MDASI-HN)
MDASI-HN is a 28 symptom items questionnaire: 13 general cancer-related symptoms, such as pain, fatigue and nausea; 9 HNC-related symptoms, such as problems with mucus in the mouth and difficulty in swallowing or chewing; 6 items to evaluate the effects of symptoms on daily life, including mood and enjoyment of life. Each item is rated on a 11-point scale from 0 (not at all) to 10 (as bad as you can imagine), while the items that assess the interference of symptoms on daily activities are rated from 0 (does not interfere) to 10 (interfered completely). Subscales and full scale range from 0-10. Higher score indicates poorer health outcome.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start12 Jul 2022
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV-positive Oropharyngeal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Non-randomized non-inferiority
- Masking
- None (open label)
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raymond Chai, Icahn School of Medicine at Mount Sinai
- Investigators
- Raymond Chai, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05419089
- Sponsor's protocol ID
- STUDY 22-00279
- Status last verified
- Jul 2026
- First submitted
- 10 Jun 2022
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Sinai Robotic Surgery Trial in HPV-related Oropharyngeal Squamous Cell Carcinoma (SIRS 2.0 Trial)
- ClinicalTrials.gov ID
- NCT05419089
- Acronym / sponsor ID
- STUDY 22-00279
- Keywords
- Oropharyngeal squamous cell carcinoma, OPSCC, Human papillomavirus, Transoral robotic surgery, TORS, HPV, p16, ctDNA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 15 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
There has been significant increase in the incidence of oropharynx cancer in North America and Europe. It is now understood that there are two dominant carcinogenic pathways for oropharyngeal squamous cell carcinoma. Environmentally related which is caused mainly by smoking and alcohol, and HPV-related oropharyngeal squamous cell carcinoma (HPVOPSCC). HPVOPSCC now accounts for over 80% of OPC seen in the USA and an increasing fraction of these malignancies in Europe. It has been shown that HPVOPSCC confers an excellent prognosis for intermediate staged disease and this has called into question the rational for aggressive concurrent chemoradiotherapy. High-dose radiotherapy (RT) and chemoradiotherapy (CRT) have substantial impact on local tissues and organ function and result in a significant rate of late mortality and morbidity. Studies are now being designed to reduce the impact of RT and CRT for patients.
Recently, a new test has been developed that measures HPV circulating tumor DNA (cfHPVDNA) in the blood. The test has emerged as a promising biomarker for HPVOPSCC, correlating with both treatment response as well as surveillance for cancer recurrence. Data suggests that a negative test in the surveillance period following treatment is highly sensitive and specific for recurrent disease.
In this trial, the study will be stratifying p16 positive patients with PCR detectable high-risk (HR) HPV DNA or RNA following TORS into risk groups based on final pathology to determine appropriate treatment intensity. Patients with low- or intermediate-risk pathologic disease and undetectable postoperative cfHPVDNA will receive no adjuvant therapy. This group includes patients with AJCC 7th edition T1-T2N0-2b disease. Patients must have less than four pathologic nodes on final pathology, negative margins, and no contralateral nodes. Perineural or lymphovascular alone is allowed but not in combination. Microscopic extranodal extension (less than or equal to 2 mm) is allowed. Patients cannot be active smokers or have a 20 or greater pack year history of smoking.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-randomized non-inferiority
| Arm | Type | Receives |
|---|---|---|
| Robotic surgery only | Experimental | Procedure: Robotic surgery* Complete resection to negative frozen section margins (pT1-2) * < 4 nodes, ≤ 2 mm extranodal extension (ENE), no supraclavicular nodes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (22 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic surgeryTransoral robotic surgical resection of the tumor with negative intraoperative frozen section margins. | Procedure or surgery | Robotic surgery only |
Primary outcome
Local and/or regional disease recurrence (LRR)
Time frame: 2 years
Local and/or regional disease recurrence (LRR) at 2 years
8 secondary outcomes
Progression-free survival (PFS)
Time frame: 2 years
Disease free survival (DFS)
Time frame: 2 years
Overall Survival (OS)
Time frame: 2 years
M.D. Anderson Dysphagia Inventory
Time frame: 2 years
Xerostomia Questionnaire (XQ)
Time frame: 2 years
European Organization of Research and Treatment Of Cancer (EORTC QLQ-C30)
Time frame: 2 years
European Organization of Research and Treatment of Head and Neck cancer questionnaire (EORTC QLQ-H&N35)
Time frame: 2 years
M.D. Anderson Symptom Inventory - Head & Neck (MDASI-HN)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
Related trials for HPV-positive Oropharyngeal Squamous Cell Carcinoma
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BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study
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Active, not recruitingPhase 2/3
Comparing Cisplatin Every Three Weeks to Cisplatin Weekly When Combined With Radiation for Patients With Advanced Head and Neck Cancer
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Testing the Addition of M3814 (Peposertib) to Radiation Therapy for Patients With Advanced Head and Neck Cancer Who Cannot Take Cisplatin
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A Vaccine (PDS0101) Alone or in Combination With Pembrolizumab for the Treatment of Locally Advanced Human Papillomavirus-Associated Oropharynx Cancer
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raymond Chai principal investigator
Icahn School of Medicine at Mount Sinai
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Robotic surgery in people with HPV-positive Oropharyngeal Squamous Cell Carcinoma, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mabel Korley ((212) 731-3297, mabel.korley@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local and/or regional disease recurrence (LRR) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.