Clinical Trial

Sentinel Node Biopsy Versus Limited Elective Neck Dissection in Early Cancers of Oral Cavity NoDe Negative

Study acronym: SECOND N0
Recruiting
View on ClinicalTrials.gov →
Summary
The goal of this clinical trial is to compare the survival outcomes, morbidity and cost-effectiveness of sentinel node biopsy versus limited elective neck dissection in node-negative early oral cancers. The main questions it aims to answer are: * Survival outcomes * Morbidity outcomes * Cost-effectiveness Participants will either undergo sentinel node biopsy followed by completion neck dissection if sentinel node is reported to be metastatic (SNB) or limited elective neck dissection where level IIb will be cleared only if level IIa is metastatic (limited END). The study will compare the outcomes in the two cohorts.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2023-03-07; most recent amendment 2025-07-14.
Status change: Not Yet Recruiting → Recruiting 2024-10-27
Trial Details
NCT Number NCT05774483
Lead Sponsor Tata Memorial Hospital
Collaborators: Tata Memorial Centre
Conditions Mouth Neoplasms, Oral Cancers, Oral Squamous Cell Carcinoma (OSCC), Oral Squamous Cell Carcinomas, Sentinel Lymph Node Biopsy, Sentinel Lymph Node Biopsy (SLNB), Sentinel Lymph Node
Enrollment 508 participants
Start Date 2025-04-16
Primary Completion 2032-04 (estimated)
Study Completion 2034-04 (estimated)
Updated on ClinicalTrials.gov 2025-07-17