Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-20-085
Prinicipal Investigator
Choi, Karen
Phase
Phase II/III
Age Group
Adult
Scope
National
Secondary Protocol No.
NRG-HN006
Title
Randomized Phase II/III Trial of Sentinel Lymph Node Biopsy Versus Elective Neck Dissection for Early-Stage Oral Cavity Cancer
Objective
Phase II: To determine if patient-reported neck and shoulder function and related quality of life (QOL) at 6 months after surgery using the Neck Dissection Impairment Index (NDII) is superior with Sentinel Lymph Node(SLN) biopsy compared to Elective Neck Dissection (END) for treatment of early-stage oral cavity squamous cell carcinoma (OCSCC) (cT1-2N0).
Phase III:To determine if disease-free survival (DFS) is non-inferior with SLN biopsy compared to END for treatment of early-stage OCSCC (cT1-2N0).
To determine if patient-reported neck and shoulder function and related QOL at 6 months after surgery using NDII is superior with SLN biopsy compared to END for treatment of early-stage OCSCC (cT1-2N0).
Applicable Disease Sites
Head and Neck
Status
Open
Participating Institutions
Hershey Medical Center