Intratumoral Lidocaine Injection Before Oropharyngeal Cancer Surgery
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
Ryan Carey
30 participants
Apr 23, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- Patients 18 years older or more.
- Histologically confirmed diagnosis of squamous cell carcinoma of the oropharynx or neck.
- Clinical T1, T2, T3, or T4 stage disease of the oropharynx (per AJCC 8th Ed).
- Any clinical N stage disease (per AJCC 8th Ed).
- Patients must be undergoing direct laryngoscopy +/- biopsy at the University of Pennsylvania as part of their work-up for consideration of definitive TORS and selective neck dissection.
- Patients must sign an informed consent document that indicates they are aware of the investigational nature of the treatment in this protocol as well as the potential risks and benefits.
- Ability to understand and the willingness to provide written informed consent.
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Exclusion Criteria7
- Prior external beam radiation therapy to the head and neck.
- Prior chemotherapy for head and neck cancer.
- Tumor invades lateral pterygoid muscle, pterygoid plates, lateral nasopharynx, or skull base or encases carotid artery (i.e. AJCC 7th Ed. T4b for OPSCC).
- Presence of distant metastatic disease.
- Uncontrolled inter-current illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, connective tissue disease or psychiatric illness/social situations that would limit compliance with study requirements.
- Known history of hypersensitivity to lidocaine or other amide local anesthetics.
- Pregnant or breastfeeding.
Interventions
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)
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NCT06747390