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.
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Parallel
Lidocaine 1% Injectable Solution
Drug1% 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.
Safety measured by occurrence of adverse events.
Adverse events (AE) and Serious Adverse Events (SAE) will use the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The CTCAE v.5 utilizes a five point scale to report AEs, defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of medical treatment or procedure that may or may not be considered related to the medical treatment or procedure.
Pathological tumor response (pTR) in the primary tumor following surgical resection.
The pathological tumor response (pTR) rate (defined as the area with pathologic response/area pathologic response plus viable tumor) will be determined by the designated study pathologist using increments of 10% for the biopsy and surgery specimens. The scores will be grouped as pTR-0 (\<10%), pTR-1 (10%-49%), and pTR-2 (≥50%).
2-year locoregional control rates.
Locoregional control is defined as control at the primary site and in the neck.
2-year progression-free survival.
Progression-free survival is defined as the length of time during and after treatment that a patient lives with the disease but it does not get worse.
2-year metastasis-free survival.
Metastasis-free survival is the length of time from the start of treatment for a disease until the patient remains alive without the development of distant metastatic disease.
2-year overall survival.
Overall survival is defined as the length of time from the start of treatment for a disease that patients diagnosed with the disease are still alive.
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Ryan Carey
Lead sponsor
Abramson Cancer Center at Penn Medicine
Sponsor institution
