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

NCT05774483 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 508

Last updated 2025-07-17

No results posted yet for this study

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.

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

Interventions

PROCEDURE

Sentinel Node Biopsy

The Sentinel node will be localized after injecting peritumoral nano colloid followed by dynamic lymphoscintigraphy and SPECT localization. Methylene blue or indocyanine green may be used but not mandatory as an adjunct for lymphoscintigraphy for node localization. Intraoperatively the node will be identified using a hand-held gamma probe. The sentinel node will be processed on a frozen section, histopathological processing with serial step sectioning, and immunohistochemistry. If reported as metastatic, then a single-stage or second-stage completion neck dissection will be performed.

PROCEDURE

Limited Elective Neck Dissection

Patients who are allocated to the limited END arm will undergo dissection of level I, IIa and III/IV nodes sparing level IIb. Level IIa will be subjected to a frozen section and if reported as metastatic will mandate clearance of level IIb.

Sponsors & Collaborators

  • Tata Memorial Centre

    collaborator OTHER

  • Tata Memorial Hospital

    lead OTHER_GOV

Principal Investigators

  • Richa Vaish, MS, M.Ch · Tata Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-16
Primary Completion
2032-04-30
Completion
2034-04-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05774483 on ClinicalTrials.gov