RANDOMIZED PHASE II/III TRIAL OF SENTINEL LYMPH NODE BIOPSY VERSUS ELECTIVE NECK DISSECTION FOR EARLY-STAGE ORAL CAVITY CANCER

Brief description of study

The purpose of the study is to compare Elective Neck Dissection (END) and Sentinel Lymph Node (SLN) Biopsy in terms of shoulder related-quality of life (QOL) and disease-free survival (DFS) in patients with early-stage oral cavity squamous cell carcinoma (OCSCC) (cT1-2N0). This study is being done to answer the following questions: 1) will neck and shoulder function and discomfort be better if you have a procedure called sentinel lymph node (SLN) biopsy instead of the usual surgery for this type of cancer; and 2) is SLN biopsy the same as the usual surgery in extending the time you have without cancer returning? One of two types of imaging agents, Lymphoseek (tilmanocept) or sulfur colloid, may be used in the SLN biopsy depending on your doctor’s preference. Lymphoseek is approved by the Food and Drug Administration (FDA) for locating lymph nodes for your type of cancer. Sulfur colloid is not FDA approved for oral cavity cancer, but it is approved for locating lymph nodes in other types of cancer.


Clinical Study Identifier: s20-01161
ClinicalTrials.gov Identifier: NCT04333537
Principal Investigator: Umamaheswar Duvvuri.
Other Investigators: Danny Perlaza, Tuyet-Phuong N Tran, Elaine Shum, Ann M Riccobene, Alec E Vaezi, Adam S Jacobson, Michael Persky, Joshua K Sabari, Catherine M Concert, Marissa Rybstein, Elise M Zahriah, Colin Hill, Moses M Tam, Caitlin Elizabeth Ryan, Megan DiBenedetto, Zujun Li, Kenneth S Hu.


If you are registered as a volunteer, please log in to contact the study team/express interest in this study.

Contact the research team to learn more about this study.

By clicking "Contact Research Team", your contact information will be sent securely to the research staff associated with the study. You will also receive a copy of this email in your inbox, as well as other notifications to determine your participation status in the study.