Condition: Tongue Cancer · Oral Cancer · Squamous Cell Carcinoma of the Oral Cavity or Oropharynx · Sponsor: Tobias Todsen
The goal of this clinical trial is to improve the surgical treatment of patients with oral cancer. We will explore whether the use of surgeon performed ultrasound during these surgeries result in better tumor removal. We hypothesize that using intraoperative ultrasound to assist the resection results in more frequent clear surgical margins in oral cancer surgeries compared to standard methods. This improvement is associated with a reduced need for post-operative adjuvant therapies such as radiotherapy and reoperation, lower mortality rates, lower cancer recurrence, and enhanced quality of life for patients undergoing surgery for oral cancer. Participants will be randomized to either the control or intervention group: * Control group will receive standard treatment for oral cancer. * Intervention group will in addition to the standard treatment have surgery performed using ultrasound to guide the resection and evaluate resection margins intraoperatively. Outcomes: * Number of free surgical margins between control and intervention group. * Intraoperative surgeon assessed surgical margins compared to final histology report. * Dysphagia and quality of life questionnaires. * Recurrence rates. * Mortality rates. All participant will be followed-up at 3 months and 12 months with: * MDADI dysphagia questionnaire * EORTC head and neck cancer quality of life questionnaire * Follow-up on recurrrence and mortality.
This description comes directly from the study's public registry record.
Daniel J Lauritzen, MD · +4541817574 · daniel.julius.lauritzen@regionh.dk
Always discuss trial participation with your own doctor first.
| Stanford Otolaryngology - Head & Neck Surgery Department | Stanford, California, United States | Not Yet Recruiting |
| Emory University Hospital | Atlanta, Georgia, United States | Not Yet Recruiting |
| Department of Otorhinolaryngology Head and Neck Surgery | Aarhus, Denmark | Recruiting |
| Department of Otorhinolaryngology Head and Neck Surgery and Audiology, Rigshospitalet | Copenhagen, Denmark | Recruiting |
| Istituto Nazionale Tumori of Milan | Milan, Italy | Not Yet Recruiting |
| Groote Schuur | Cape Town, South Africa | Not Yet Recruiting |
| Karolinska Institute | Stockholm, Sweden | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07203911