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The Sinai Robotic Surgery Trial in HPV-related Oropharyngeal Squamous Cell Carcinoma (SIRS 2.0 Trial)

ConditionHPV-positive Oropharyngeal Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Unstable cardiac disease despite treatment or myocardial infarction within 6 months prior to study entry.

Trial design

Design model

Single group

Treatments tested in this trial

  • Robotic surgery

    Procedure/Surgery

    Transoral robotic surgical resection of the tumor with negative intraoperative frozen section margins.

Treatment groups

83 Participants
are divided into 1 treatment group
Group A: Robotic surgery onlyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Local and/or regional disease recurrence (LRR)

Local and/or regional disease recurrence (LRR) at 2 years

Time frame
2 years

Secondary outcomes

1

Progression-free survival (PFS)

PFS at 2 years as defined as the proportion of patients without events (recurrence or death) at 2 years

Time frame
2 years
2

Disease free survival (DFS)

PFS at 2 years as defined as the proportion of patients without events (recurrence or death) at 2 years

Time frame
2 years
3

Overall Survival (OS)

OS at 2 years is defined as the proportion of patients alive at 2 years

Time frame
2 years
4

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.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Icahn School of Medicine at Mount Sinai

Lead sponsor

Source ClinicalTrials.gov
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