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RECRUITING
NCT06747390
PHASE1

Intratumoral Lidocaine Injection Before Oropharyngeal Cancer Surgery

Sponsor: Ryan Carey

View on ClinicalTrials.gov

Summary

Based on evidence that the local anesthetic lidocaine may have anticancer effects, this study will assess the safety and efficacy of intratumoral lidocaine injection at the time of direct laryngoscopy prior to TransOral Robotic Surgery (TORS) and neck dissection for oropharyngeal squamous cell carcinoma (OPSCC). The primary objective of the study is to determine if intratumoral lidocaine injection is safe and causes a major pathologic treatment effect in the primary tumor following surgical resection. The secondary objectives will be to determine if intratumoral lidocaine injection improves locoregional control rates, progression-free survival, metastasis-free survival, and overall survival compared to no injection.

Official title: A Phase I Randomized Controlled Trial of Intratumoral Lidocaine Injection Before Transoral Robotic Surgery (TORS) and Neck Dissection for HPV-Associated Oropharyngeal Squamous Cell Carcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-04-23

Completion Date

2028-11-01

Last Updated

2025-04-29

Healthy Volunteers

No

Interventions

DRUG

Lidocaine 1% Injectable Solution

1% lidocaine will be injected under direct visualization (not exceeding the maximum tolerated dose of 4.5 mg/kg body weight) into the primary tumor with the aim to distribute the lidocaine evenly into the tumor.

Locations (1)

Abramson Cancer Center at University of Pennsylvania

Philadelphia, Pennsylvania, United States