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Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection for Patients With Early-Stage Oral Cavity Cancer

NCT04333537 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 686

Last updated 2026-05-04

No results posted yet for this study

Summary

This phase II/III trial studies how well sentinel lymph node biopsy works and compares sentinel lymph node biopsy surgery to standard neck dissection as part of the treatment for early-stage oral cavity cancer. Sentinel lymph node biopsy surgery is a procedure that removes a smaller number of lymph nodes from your neck because it uses an imaging agent to see which lymph nodes are most likely to have cancer. Standard neck dissection, such as elective neck dissection, removes many of the lymph nodes in your neck. Using sentinel lymph node biopsy surgery may work better in treating patients with early-stage oral cavity cancer compared to standard elective neck dissection.

Conditions

  • Buccal Mucosa Squamous Cell Carcinoma
  • Floor of Mouth Squamous Cell Carcinoma
  • Gingival Squamous Cell Carcinoma
  • Hard Palate Squamous Cell Carcinoma
  • Lip Squamous Cell Carcinoma
  • Lower Alveolar Ridge Squamous Cell Carcinoma
  • Oral Cavity Squamous Cell Carcinoma
  • Retromolar Trigone Squamous Cell Carcinoma
  • Stage I Lip and Oral Cavity Cancer AJCC v8
  • Stage II Lip and Oral Cavity Cancer AJCC v8
  • Tongue Squamous Cell Carcinoma
  • Upper Alveolar Ridge Squamous Cell Carcinoma

Interventions

PROCEDURE

Chest Radiography

Undergo chest x-ray

PROCEDURE

Computed Tomography

Undergo SPECT/CT scan and FDG PET/CT or CT

OTHER

Fludeoxyglucose F-18

Undergo FDG PET/CT

DRUG

Imaging Agent

Receive imaging agent via injection

PROCEDURE

Neck Dissection

Undergo standard elective neck dissection

PROCEDURE

Planar Imaging

Undergo planar imaging

PROCEDURE

Positron Emission Tomography

Undergo FDG PET/CT

OTHER

Questionnaire Administration

Ancillary studies

PROCEDURE

Sentinel Lymph Node Biopsy

Undergo SLN biopsy

PROCEDURE

Single Photon Emission Computed Tomography

Undergo SPECT/CT scan

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • NRG Oncology

    lead OTHER

Principal Investigators

  • Stephen Y Lai · NRG Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-23
Primary Completion
2031-04-27
Completion
2031-04-27

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Companies

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 NCT04333537 on ClinicalTrials.gov