Actively Recruiting
Intratumoral Lidocaine Injection Before Oropharyngeal Cancer Surgery
Led by Ryan Carey · Updated on 2026-05-12
30
Participants Needed
1
Research Sites
184 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intratumoral Lidocaine Injection Before Oropharyngeal Cancer Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 for consideration of definitive TORS and selective neck dissection.
- Patients must sign informed consent acknowledging the investigational nature of the treatment and potential risks and benefits.
- Ability and willingness to provide written informed consent.
You will not qualify if you...
- Prior external beam radiation therapy to the head and neck.
- Prior chemotherapy for head and neck cancer.
- Tumor invading lateral pterygoid muscle, pterygoid plates, lateral nasopharynx, skull base, or encasing carotid artery (AJCC 7th Ed. T4b for OPSCC).
- Presence of distant metastatic disease.
- Uncontrolled serious illnesses including symptomatic heart failure, unstable angina, connective tissue disease, psychiatric illness, or social situations limiting study compliance.
- Known allergy to lidocaine or other amide local anesthetics.
- Pregnancy or breastfeeding.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Abramson Cancer Center at University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
R
Ryan Carey, MD
CONTACT
P
Prannda Sharma, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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