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New treatment option for HPV-positive Oropharyngeal Squamous Cell Carcinoma
Official title The Sinai Robotic Surgery Trial in HPV-related Oropharyngeal Squamous Cell Carcinoma (SIRS 2.0 Trial)
ClinicalTrials.gov ID: NCT05419089
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must have histologically or cytologically confirmed and identified resectable primary OPSCC with positive p16 immunohistochemistry, defined...
- Patients enrolled in the trial must have pre-surgery baseline cfHPVDNA using the NavDX assay (Naveris, Cambridge, MA). Detectable baseline cfHPVDNA...
- Undetectable cfHPVDNA after surgery. All patients should have a repeat cfHPVDNA test within 1 to 5 weeks post-operatively and prior to treatment...
- AJCC 7th edition early and intermediate stage (T1N0-2B, T2N0-2B) (non-matted) disease without evidence of distant metastases or gross extranodal...
- Age ≥ 18 years at screening
You likely can't join 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...
- 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
See the full eligibility criteria
Who can 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...
- 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...
- 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...
- 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
What rules you out
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Paramus, New Jersey, United States
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paramus, New Jersey, United States; New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.