NCT06747390RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 12 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 16 Dec 2024
- Start date
- 23 Apr 2025
- Primary completion date
- 1 Nov 2026
- Lead sponsor
- Ryan Carey
- Diseases
- Head and neck cancer
- NCT number
- NCT06747390
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 30
- From 23 Apr 2025 to the primary completion date, 1 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior external beam radiation therapy to the head and neck.
- Prior chemotherapy for head and neck cancer.
Other illness
- 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.
Other
- Tumor invades lateral pterygoid muscle, pterygoid plates, lateral nasopharynx, or skull base or encases carotid artery (i.e. AJCC 7th Ed. T4b for OPSCC).
- Pregnant or breastfeeding.
Who the study is looking for
- 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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Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Abramson Cancer Center at University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.