CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 686 target
Drug / intervention
Imaging Agent +9 moredrug
Likely dose
Not stated in record
Key inclusion· 10
  • ✓Pathologically proven squamous cell carcinoma of oral cavity sites (tongue, floor of mouth, lip, buccal mucosa, alveolar ridge, retromolar gingiva, hard palate)
  • ✓Stage T1-2N0M0 per AJCC 8th edition
  • ✓History/physical examination within 42 days prior to registration
  • ✓Head and neck imaging (PET/CT, contrast CT, MRI, or ultrasound) within 42 days prior to registration
Key exclusion· 13
  • ✕Clinical or radiologic evidence of regional or distant metastatic disease
  • ✕Prior non-head and neck invasive malignancy unless disease-free ≥2 years (except non-melanomatous skin cancer or in situ breast/cervix carcinoma)
  • ✕Head and neck SCC in oropharynx, nasopharynx, hypopharynx, or larynx
  • ✕Prior systemic chemotherapy for the study cancer

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04333537
NCT04333537Phase 2RecruitingHigh Momentum
Long Recruiting
CompareCT.gov

Randomized Phase II/III Trial of Sentinel Lymph Node Biopsy Versus Elective Neck Dissection for Early-Stage Oral Cavity Cancer

NRG Oncology·interventional·Posted Apr 3, 2020·Updated Jun 25, 2026

In Brief

A Phase 2 clinical trial evaluating Chest Radiography, Computed Tomography, and 8 other interventions for Buccal Mucosa Squamous Cell Carcinoma and 11 related conditions. Currently recruiting, targeting 686 participants across 107 sites in 2 countries.

Signals

Enrolling ahead of pace

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBuccal 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
CountriesCanada, United States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2Recruiting
202020212022202320242025202620272028202920302031
First PostedApr 3, 2020
Enrollment StartSep 23, 2020
Primary CompletionApr 27, 2031
TodayJul 2, 2026
Enrollment to primary: 10.6 yearsPosted 6.2 years agoPrimary completion in 4.8 years

Arms & Interventions

Group I (SLN biopsy)experimental

Patients receive an imaging agent via injection and undergo planar imaging and SPECT/CT over 1-2 hours. Patients then undergo SLN biopsy. Patients also undergo FDG PET/CT, CT, and/or chest x-ray at screening and during follow up.

Procedure: Chest RadiographyProcedure: Computed TomographyOther: Fludeoxyglucose F-18Drug: Imaging AgentProcedure: Planar ImagingProcedure: Positron Emission TomographyOther: Questionnaire AdministrationProcedure: Sentinel Lymph Node BiopsyProcedure: Single Photon Emission Computed Tomography
Group II (END)active_comparator

Patients undergo standard END. Patients also undergo FDG PET/CT, CT, and/or chest x-ray at screening and during follow up.

Procedure: Chest RadiographyOther: Fludeoxyglucose F-18Procedure: Neck DissectionProcedure: Positron Emission TomographyOther: Questionnaire Administration

Interventions

Chest Radiographyprocedure

Undergo chest x-ray

Computed Tomographyprocedure

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

Fludeoxyglucose F-18other

Undergo FDG PET/CT

Imaging Agentdrug

Receive imaging agent via injection

Neck Dissectionprocedure

Undergo standard elective neck dissection

Planar Imagingprocedure

Undergo planar imaging

Positron Emission Tomographyprocedure

Undergo FDG PET/CT

Questionnaire Administrationother

Ancillary studies

Sentinel Lymph Node Biopsyprocedure

Undergo SLN biopsy

Single Photon Emission Computed Tomographyprocedure

Undergo SPECT/CT scan