This phase I trial studies the side effects and effectiveness of injecting lidocaine into the tumor (intratumoral) before transoral robotic surgery (TORS) and neck dissection for treating patients with human papillomavirus (HPV)-associated oropharyngeal squamous cell carcinoma (OPSCC). Lidocaine is frequently used during surgery (including throat surgery) to reduce pain. Lidocaine may activate cell death in tumor cells and/or limit spread of the cancer from where it first started (primary site) to other places in the body (metastasis). Giving intratumoral lidocaine before TORS and neck dissection may kill more tumor cells in patients with HPV-associated OPSCC.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06747390.
Locations matching your search criteria
United States
Pennsylvania
Philadelphia
University of Pennsylvania/Abramson Cancer CenterStatus: Active
Contact: Ryan M. Carey
Phone: 610-790-9202
PRIMARY OBJECTIVE:
I. Determine if intratumoral 1% lidocaine injection at the time of direct laryngoscopy prior to TORS and neck dissection for HPV associated OPSCC is safe and causes a major pathologic treatment effect.
SECONDARY OBJECTIVE:
I. Determine if intratumoral 1% lidocaine injection at the time of direct laryngoscopy prior to TORS and neck dissection for HPV associated OPSCC improves the locoregional control rates, progression-free survival, metastasis-free survival, and overall survival compared to no injection.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP 1: Patients receive lidocaine intratumorally during standard of care (SOC) laryngoscopy and biopsy. Patients also undergo collection of blood and tissue samples on study.
GROUP 2: Patients receive no injection during SOC laryngoscopy and biopsy. Patients also undergo collection of blood and tissue samples on study.
After completion of study intervention, patients are followed up routinely per recommended guidelines for 2 years.
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
Principal InvestigatorRyan M. Carey
