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New treatment option for Oropharyngeal Squamous Cell Carcinoma (OPSCCA)
Official title Intratumoral Lidocaine Injection Before Oropharyngeal Cancer Surgery
ClinicalTrials.gov ID: NCT06747390
What this study is testing
What is Lidocaine 1% Injectable Solution?
Lidocaine 1% Injectable Solution is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for oropharyngeal squamous cell carcinoma (opscca).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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...
- Presence of distant metastatic disease.
- Uncontrolled inter-current illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, connective tissue...
- Known history of hypersensitivity to lidocaine or other amide local anesthetics.
See the full eligibility criteria
- 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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- 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...
- Known history of hypersensitivity to lidocaine or other amide local anesthetics.
- Pregnant or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.