[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573523":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":38,"responsibleParty":53,"collaborators":12,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":12,"enrollmentInfo":67,"targetDuration":12,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":79,"overallStatus":41,"whyStopped":12,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Abramson Cancer Center at Penn Medicine","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control Arm - No Injection","NO_INTERVENTION","No injection at the time of direct laryngoscopy.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Lidocaine Injectible product","EXPERIMENTAL","Intratumoral injection of 1% lidocaine at the time of direct laryngoscopy.",[18],"Drug: Lidocaine 1% Injectable Solution",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DRUG","Lidocaine 1% Injectable Solution","1% lidocaine will be injected under direct visualization (not exceeding the maximum tolerated dose of 4.5 mg\u002Fkg body weight) into the primary tumor with the aim to distribute the lidocaine evenly into the tumor.",[14],[26],{"name":27,"affiliation":28,"role":29},"Ryan Carey, MD","University of Pennsylvania","PRINCIPAL_INVESTIGATOR",[31,35],{"name":27,"role":32,"phone":33,"phoneExt":12,"email":34},"CONTACT","2156622777","ryan.carey@pennmedicine.upenn.edu",{"name":36,"role":32,"phone":12,"phoneExt":12,"email":37},"Prannda Sharma, MS","pranndas@pennmedicine.upenn.edu",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":12},"Abramson Cancer Center at University of Pennsylvania","RECRUITING","Philadelphia","Pennsylvania","19104","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-75.16362,39.95238,{"lat":51,"lon":50},{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"SPONSOR_INVESTIGATOR","Ryan Carey","Assistant Professor","100573523","phase-1-intratumoral-lidocaine-injection-before-oropharyngeal-cancer-surgery-100573523",false,"NCT06747390","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","856397","Inclusion Criteria:\n\nPatients 18 years older or more.\n\nHistologically confirmed diagnosis of squamous cell carcinoma of the oropharynx or neck.\n\nClinical T1, T2, T3, or T4 stage disease of the oropharynx (per AJCC 8th Ed).\n\nAny clinical N stage disease (per AJCC 8th Ed).\n\nPatients must be undergoing direct laryngoscopy +\u002F- biopsy at the University of Pennsylvania as part of their work-up for consideration of definitive TORS and selective neck dissection.\n\nPatients 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.\n\nAbility to understand and the willingness to provide written informed consent.\n\n\\---\n\nExclusion Criteria:\n\nPrior external beam radiation therapy to the head and neck.\n\nPrior chemotherapy for head and neck cancer.\n\nTumor invades lateral pterygoid muscle, pterygoid plates, lateral nasopharynx, or skull base or encases carotid artery (i.e. AJCC 7th Ed. T4b for OPSCC).\n\nPresence of distant metastatic disease.\n\nUncontrolled inter-current illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, connective tissue disease or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n\nKnown history of hypersensitivity to lidocaine or other amide local anesthetics.\n\nPregnant or breastfeeding.","ALL","18 Years",{"count":68,"type":69},30,"ESTIMATED","INTERVENTIONAL",[72],"PHASE1","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.",[75,76,77,78],"Oropharyngeal Squamous Cell Carcinoma (OPSCCA)","Oropharyngeal Cancer","Human Papilloma Virus","Squamous Cell Carcinoma",[80,81,76,77,78,82],"TransOral Robotic Surgery (TORS)","Oropharyngeal Squamous Cell Carcinoma","Lidocaine","2026-05-10",{"date":85,"type":86},"2026-05-12","ACTUAL",{"date":88,"type":86},"2025-04-23",{"date":90,"type":69},"2028-11-01",{"name":55,"class":6},1]