Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06747390

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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.
Not Eligible

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.

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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

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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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