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

Brief description of study

This study is designed as a randomized, phase II/III trial aiming at comparing 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). The phase II uses a superiority design with shoulder-related quality of life (QOL), as measured by the Neck Dissection Impairment Index (NDII), as the primary endpoint. The phase III portion is a non-inferiority trial with DFS as the primary endpoint. The NDII is a hierarchical co-primary endpoint for the phase III. Patients enrolled to the phase II will be included in the primary endpoint analysis of the phase III based on 618 randomized patients. In phase II, 194 randomized patients are required for the analysis after accounting for QOL non-compliance, so 228 patients will be randomized. With this trial, the difference in 6-month NDII scores between arms in the phase II will determine if the study should proceed to a phase III study (“Go/No-Go” decision) to evaluate DFS and NDII. The phase II portion will also determine the feasibility for conducting a SLN biopsy-related study in the NCTN setting. While sufficient DFS events will not be available during the phase II portion of the study, evaluation of the NDII scores between arms in the intermediate (6 month) period, will allow for moving into a phase III study based upon shoulder-related QOL for patients treated with SLN biopsy compared to END, potentially shortening the overall duration of the study if no shoulder-related QOL difference between the surgical arms is detectable. Enrolled OCSCC patients with FDG PET/CT negative result will be stratified by clinical and radiographic T-stage (T1 vs. T2) and Zubrod performance status (0 vs 1-2) before being randomized to receive either SLN biopsy or END in a 1:1 ratio. Enrolled OCSCC patients with FDG PET/CT positive result will go off study and their pathology findings will be collected into a neck registry. This trial implements a permuted block randomization to randomize patients within each strata cell.


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


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