Clinical trialNCT04333537RecruitingPhase 2/PHASE3Interventional

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

SponsorNRG OncologyEnrollment686Buccal Mucosa Squamous Cell CarcinomaFloor of Mouth Squamous Cell CarcinomaGingival Squamous Cell CarcinomaHard Palate Squamous Cell CarcinomaLip Squamous Cell CarcinomaLower Alveolar Ridge Squamous Cell Carcinoma+6 more conditions

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Stephen Y Lai
NRG Oncology
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

107 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada

University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada
John R. de Almeida
Recruiting

United States

University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Withdrawn
Banner Md Anderson Cancer Center
Gilbert, Arizona, United States
Thomas D. Shellenberger
Recruiting
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, United States
Kyle S. Ettinger
Recruiting
Banner University Medical Center - Tucson
Tucson, Arizona, United States
Steven J. Wang
Recruiting
University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States
Steven J. Wang
Recruiting
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Emre A. Vural
Recruiting
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Active, not recruiting
Uc San Diego Moores Cancer Center
La Jolla, California, United States
Theresa Guo
Recruiting
Stanford Cancer Institute Palo Alto
Palo Alto, California, United States
Fred Baik
Recruiting
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Active, not recruiting
Uc San Diego Medical Center - Hillcrest
San Diego, California, United States
Theresa Guo
Recruiting
Ucsf Medical Center-Mission Bay
San Francisco, California, United States
Jason Chan
Recruiting
Stanford Cancer Center South Bay
San Jose, California, United States
Fred Baik
Recruiting
Yale University
New Haven, Connecticut, United States
Saral Mehra
Recruiting
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, United States
Saral Mehra
Recruiting
Um Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States
Francisco J. Civantos
Recruiting
Um Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States
Francisco J. Civantos
Recruiting
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
Francisco J. Civantos
Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, United States
Jennifer Gross
Recruiting
Emory University Hospital/winship Cancer Institute
Atlanta, Georgia, United States
Jennifer Gross
Recruiting
Northwestern University
Chicago, Illinois, United States
Sandeep Samant
Recruiting
Rush Md Anderson Cancer Center
Chicago, Illinois, United States
Mihir K. Bhayani
Recruiting
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Suspended
Springfield Memorial Hospital
Springfield, Illinois, United States
Suspended
Heartland Oncology and Hematology Llp
Council Bluffs, Iowa, United States
Aru Panwar
Recruiting
Methodist Jennie Edmundson Hospital
Council Bluffs, Iowa, United States
Aru Panwar
Recruiting
University of Iowa/holden Comprehensive Cancer Center
Iowa City, Iowa, United States
Nitin A. Pagedar
Recruiting
University of Kansas Cancer Center
Kansas City, Kansas, United States
Andres M. Bur
Recruiting
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States
Andres M. Bur
Recruiting
University of Kentucky/markey Cancer Center
Lexington, Kentucky, United States
Mark E. Bernard
Recruiting
the James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States
Suspended
Lsu Health Sciences Center at Shreveport
Shreveport, Louisiana, United States
Suspended
Boston Medical Center
Boston, Massachusetts, United States
Suspended
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
Marisa R. Buchakjian
Recruiting
Henry Ford Hospital
Detroit, Michigan, United States
Eleanor M. Walker
Recruiting
Wayne State University/karmanos Cancer Institute
Detroit, Michigan, United States
John D. Cramer
Recruiting
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States
John D. Cramer
Recruiting
Henry Ford Medical Center-Columbus
Novi, Michigan, United States
Eleanor M. Walker
Recruiting
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, United States
Eleanor M. Walker
Recruiting

67 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Imaging Agent

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 23 Sept 2020
Primary completion: 27 Apr 2031
Completion: 27 Apr 2036
Last update posted: 17 Aug 2026
Registered enrollment: 686
Registry id: NCT04333537

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.