The Sinai Robotic Surgery Trial in HPV-related Oropharyngeal Squamous Cell Carcinoma (SIRS 2.0 Trial)
1 other identifier
interventional
83
1 country
2
Brief 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 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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2022
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2022
CompletedFirst Posted
Study publicly available on registry
June 15, 2022
CompletedStudy Start
First participant enrolled
July 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
June 13, 2025
June 1, 2025
4.9 years
June 10, 2022
June 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Local and/or regional disease recurrence (LRR)
Local and/or regional disease recurrence (LRR) at 2 years
2 years
Secondary Outcomes (8)
Progression-free survival (PFS)
2 years
Disease free survival (DFS)
2 years
Overall Survival (OS)
2 years
M.D. Anderson Dysphagia Inventory
2 years
Xerostomia Questionnaire (XQ)
2 years
- +3 more secondary outcomes
Study Arms (1)
Robotic surgery only
EXPERIMENTAL* Complete resection to negative frozen section margins (pT1-2) * \< 4 nodes, ≤ 2 mm extranodal extension (ENE), no supraclavicular nodes
Interventions
Transoral robotic surgical resection of the tumor with negative intraoperative frozen section margins.
Eligibility Criteria
You may qualify if:
- 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.
- 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
You may not qualify if:
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Valley - Mount Sinai Comprehensive Cancer Care
Paramus, New Jersey, 07652, United States
Mount Sinai Health System
New York, New York, 10019, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raymond Chai
Icahn School of Medicine at Mount Sinai
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Otolaryngology
Study Record Dates
First Submitted
June 10, 2022
First Posted
June 15, 2022
Study Start
July 12, 2022
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
June 13, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Immediately following publication. No end date.
All of the individual participant data collected during the trial, after deidentification.