At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed resectable primary OPSCC with positive p16 immunohistochemistry (strong and diffuse >70% of tumor cells)
- ✓HR-HPV positive status confirmed
- ✓Pre-surgery baseline cfHPVDNA ≥10 fragments/mL using NavDX assay
- ✓Post-surgery cfHPVDNA undetectable (<5 fragments/mL) within 1-5 weeks
- ✕Age <18 years at screening
- ✕Pregnant or breast-feeding women
- ✕Prior malignancies at other sites except adequately treated in situ cervical carcinoma, skin basal/squamous cell carcinoma, thyroid cancer, or prostate/breast/other cancer curatively treated with ≥3 years disease-free
- ✕Unstable cardiac disease or myocardial infarction within 6 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Sinai Robotic Surgery Trial in HPV-related Oropharyngeal Squamous Cell Carcinoma (SIRS 2.0 Trial)
In Brief
A Phase 2 clinical trial evaluating Robotic surgery for HPV-positive Oropharyngeal Squamous Cell Carcinoma. Currently recruiting, targeting 83 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
Transoral robotic surgical resection of the tumor with negative intraoperative frozen section margins.