Phase I Trial of Intratumoral Lidocaine Injection Before Transoral Robotic Surgery and Neck Dissection for HPV-Related Oropharyngeal Cancer

What this Trial Is About

Researchers are evaluating intratumoral lidocaine injection for patients with HPV-associated oropharyngeal squamous cell carcinoma OPSCC undergoing surgery. This phase I randomized controlled trial aims to determine if injecting 1% lidocaine into the tumor before TransOral Robotic Surgery TORS and neck dissection is safe and causes a major pathologic treatment effect. The study will also investigate whether lidocaine injection improves locoregional control, progression-free survival, metastasis-free survival, and overall survival compared to no injection. Participants will be randomly assigned to receive either an intratumoral injection of 1% lidocaine or no injection at the time of direct laryngoscopy under general anesthesia. The lidocaine dose will not exceed 4.5 mgkg body weight and will be injected directly into the primary tumor. After the study intervention, patients will receive standard care, which may include surgery TORS with neck dissection or radiation therapy, with or without chemotherapy. Blood samples will be collected before and after the intervention to monitor effects. During the trial, researchers will assess safety by monitoring adverse events and evaluate the pathological tumor response in surgical specimens. Tumor response will be measured by the area of pathologic change in the tumor tissue. Patients not proceeding to surgery or found to have non-HPV OPSCC pathology will not be included in the primary analysis. The study aims to enroll 30 evaluable patients, with follow-up for up to two years to assess tumor control and survival outcomes.

Intratumoral Lidocaine Injection Before Oropharyngeal Cancer Surgery