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

Part of paid clinical trials in Paramus, New Jersey.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT05419089
Phase
PHASE2
Status
Recruiting
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Conditions

  • HPV-positive Oropharyngeal Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Robotic surgery — PROCEDURE
    Transoral robotic surgical resection of the tumor with negative intraoperative frozen section margins.

Study Details

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.

Key Dates

Start date
Jul 12, 2022
Status verified
Jun 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
83 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Robotic surgery only
    * Complete resection to negative frozen section margins (pT1-2) * \< 4 nodes, ≤ 2 mm extranodal extension (ENE), no supraclavicular nodes

Primary Outcome Measure

Local and/or regional disease recurrence (LRR) [ Time Frame: 2 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Valley - Mount Sinai Comprehensive Cancer CareParamusNew Jersey07652-
Mount Sinai Health SystemNew YorkNew York10019
Raymond Chai, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Paramus, NJ

By research site
Valley - Mount Sinai Comprehensive Cancer Care· Paramus, NJMount Sinai Health System· New York, NY

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