Recruiting
Phase 2
Phase 3

Sentinel Lymph Node Biopsy vs. Neck Dissection

Sponsor:

NRG Oncology

Code:

NCT04333537

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Chest Radiography

Computed Tomography

Fludeoxyglucose F-18

Imaging Agent

Neck Dissection

Study Details

Brief 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

Study ID

NCT04333537

Start date

Sep 23, 2020

Status verified date

Aug, 2026

Completion date

Apr 27, 2036

Anticipated

Primary completion date

Apr 27, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • PRIOR TO STEP 1 REGISTRATION INCLUSION:
  • Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (SCC) of the oral cavity, including the oral (mobile) tongue, floor of mouth (FOM), mucosal lip, buccal mucosa, lower alveolar ridge, upper alveolar ridge, retromolar gingiva (retromolar trigone; RMT), or hard palate prior to registration
  • Appropriate stage for study entry (T1-2N0M0; American Joint Committee on Cancer \[AJCC\] 8th edition \[ed.\]) based on the following diagnostic workup:

  • History/physical examination within 42 days prior to registration
  • Imaging of head and neck within 42 days prior to registration

  • PET/CT scan or contrast neck CT scan, or gadolinium-enhanced neck magnetic resonance imaging (MRI) or lateral and central neck ultrasound; diagnostic quality CT is preferred and highly recommended as part of the PET/CT when possible
  • Imaging of chest within 42 days prior to registration

  • Chest x-ray, CT chest scan (with or without contrast), or PET/CT (with or without contrast)
  • Surgical assessment within 42 days prior to registration. Patient must be a candidate for surgical intervention with sentinel lymph node (SLN) biopsy and potential completion neck dissection (CND) or elective neck dissection (END)

  • Surgical resection of the primary tumor will occur through a transoral approach with anticipation of resection free margins
  • Age >= 18
  • Zubrod performance status 0-2 within 42 days prior to registration
  • For women of child-bearing potential, negative serum or urine pregnancy test within 42 days prior to registration
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
  • Only patients who are able to read and understand English or French are eligible to participate as the mandatory patient reported NDII tool is only available in these languages
  • PRIOR TO STEP 2 RANDOMIZATION:
  • FDG PET/CT required prior to step 2. Note: FDG PET/CT done prior to step 1 can be submitted for central review

  • PET/CT node negative patients, determined by central read, will proceed to randomization. PET/CT node positive patients will go off study, but will be entered in a registry and data will be collected to record the pathological outcome of neck nodes for diagnostic imaging assessment and future clinical trial development

  • NOTE: All FDG PET/CT scans must be performed on an American College of Radiology (ACR) accredited scanner (or similar accrediting organization)
  • The patient must complete NDII prior to step 2 registration

Exclusion Criteria:

  • PRIOR TO STEP 1 REGISTRATION EXCLUSION:
  • Definitive clinical or radiologic evidence of regional (cervical) and/or distant metastatic disease
  • Prior non-head and neck invasive malignancy (except non-melanomatous skin cancer, including effectively treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or cervix) unless disease free for ≥ 2 years
  • Diagnosis of head and neck SCC in the oropharynx, nasopharynx, hypopharynx, and larynx
  • Unable or unwilling to complete NDII (baseline only)
  • Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for different cancer(s) is allowable
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Severe, active co-morbidity that would preclude an elective or completion neck dissection
  • Pregnancy and breast-feeding mothers
  • Incomplete resection of oral cavity lesion with a positive margin; however, an excisional biopsy is permitted
  • Prior surgery involving the lateral neck, including neck dissection or gross injury to the neck that would preclude surgical dissection for this trial. Prior thyroid and central neck surgery is permissible; biopsy is permitted. Note: Borderline suspicious nodes that are >= 1 cm with radiographic finding suggestive of NOT malignant should be biopsied using ultrasound (U/S)-guided fine-needle aspiration (FNA) biopsy
  • Underlying or documented history of hematologic malignancy (e.g., chronic lymphocytic leukemia \[CLL\]) or other active disease capable of causing lymphadenopathy (e.g., sarcoidosis or untreated mycobacterial infection)
  • Actively receiving systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte or immunomodulatory therapy
  • Currently participating in another investigational therapeutic trial

Study Design

Enrollment

686 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group I (SLN biopsy)

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.

active comparator: Group II (END)

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

Interventions

Chest Radiography

Undergo chest x-ray

Computed Tomography

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

Fludeoxyglucose F-18

Undergo FDG PET/CT

Imaging Agent

Receive imaging agent via injection

Neck Dissection

Undergo standard elective neck dissection

Planar Imaging

Undergo planar imaging

Positron Emission Tomography

Undergo FDG PET/CT

Questionnaire Administration

Ancillary studies

Sentinel Lymph Node Biopsy

Undergo SLN biopsy

Single Photon Emission Computed Tomography

Undergo SPECT/CT scan

Primary outcome measure

  • Patient-reported neck and shoulder function (Phase II/III) [ Time Frame: Before surgery (Baseline), 3 weeks after surgery, 3, 6, 12 months after surgery ]
  • Patient reported quality of life (QOL) (Phase II) [ Time Frame: Before surgery (Baseline), 3 weeks after surgery, 3, 6, 12 months after surgery ]
  • Disease-free survival (DFS) (phase III) [ Time Frame: From randomization to local/regional recurrence, distant metastasis, or death due to any cause, whichever comes first, assessed up to 11 years ]

Central Contacts and Locations

Locations

Banner MD Anderson Cancer Center

Recruiting

Gilbert, Arizona, United States, 85234

Contacts

Site Public Contact

602-747-9738

Principal Investigator:

Thomas D. Shellenberger

Mayo Clinic Hospital in Arizona

Recruiting

Phoenix, Arizona, United States, 85054

Contacts

Site Public Contact

855-776-0015

Principal Investigator:

Kyle S. Ettinger

Banner University Medical Center - Tucson

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Site Public Contact

UACC-IIT@uacc.arizona.edu

Principal Investigator:

Steven J. Wang

University of Arizona Cancer Center-North Campus

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Site Public Contact

UACC-IIT@uacc.arizona.edu

Principal Investigator:

Steven J. Wang

University of Arkansas for Medical Sciences

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Site Public Contact

501-686-8274

Principal Investigator:

Emre A. Vural

UC San Diego Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093

Contacts

Principal Investigator:

Theresa Guo

Stanford Cancer Institute Palo Alto

Recruiting

Palo Alto, California, United States, 94304

Contacts

Principal Investigator:

Fred Baik

UC San Diego Medical Center - Hillcrest

Recruiting

San Diego, California, United States, 92103

Contacts

Site Public Contact

rhabbaba@health.ucsd.edu

Principal Investigator:

Theresa Guo

UCSF Medical Center-Mission Bay

Recruiting

San Francisco, California, United States, 94158

Contacts

Principal Investigator:

Jason Chan

Stanford Cancer Center South Bay

Recruiting

San Jose, California, United States, 95124

Contacts

Principal Investigator:

Fred Baik

Yale University

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Principal Investigator:

Saral Mehra

Smilow Cancer Hospital Care Center-Trumbull

Recruiting

Trumbull, Connecticut, United States, 06611

Contacts

Principal Investigator:

Saral Mehra

UM Sylvester Comprehensive Cancer Center at Coral Gables

Recruiting

Coral Gables, Florida, United States, 33146

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

Francisco J. Civantos

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Recruiting

Deerfield Beach, Florida, United States, 33442

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

Francisco J. Civantos

University of Miami Miller School of Medicine-Sylvester Cancer Center

Recruiting

Miami, Florida, United States, 33136

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

Francisco J. Civantos

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Site Public Contact

888-946-7447

Principal Investigator:

Jennifer Gross

Emory University Hospital/Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Site Public Contact

404-778-1868

Principal Investigator:

Jennifer Gross

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Principal Investigator:

Sandeep Samant

Rush MD Anderson Cancer Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Principal Investigator:

Mihir K. Bhayani

Heartland Oncology and Hematology LLP

Recruiting

Council Bluffs, Iowa, United States, 51503

Contacts

Site Public Contact

712-322-4136

Principal Investigator:

Aru Panwar

Methodist Jennie Edmundson Hospital

Recruiting

Council Bluffs, Iowa, United States, 51503

Contacts

Principal Investigator:

Aru Panwar

University of Iowa/Holden Comprehensive Cancer Center

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Site Public Contact

800-237-1225

Principal Investigator:

Nitin A. Pagedar

University of Kansas Cancer Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Principal Investigator:

Andres M. Bur

University of Kansas Hospital-Westwood Cancer Center

Recruiting

Westwood, Kansas, United States, 66205

Contacts

Principal Investigator:

Andres M. Bur

University of Kentucky/Markey Cancer Center

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Site Public Contact

859-257-3379

Principal Investigator:

Mark E. Bernard

University of Michigan Rogel Cancer Center

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Principal Investigator:

Marisa R. Buchakjian

Wayne State University/Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Principal Investigator:

John D. Cramer

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Principal Investigator:

Eleanor M. Walker

Weisberg Cancer Treatment Center

Recruiting

Farmington Hills, Michigan, United States, 48334

Contacts

Principal Investigator:

John D. Cramer

Henry Ford Medical Center-Columbus

Recruiting

Novi, Michigan, United States, 48377

Contacts

Principal Investigator:

Eleanor M. Walker

Henry Ford West Bloomfield Hospital

Recruiting

West Bloomfield, Michigan, United States, 48322

Contacts

Principal Investigator:

Eleanor M. Walker

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Site Public Contact

855-776-0015

Principal Investigator:

Kyle S. Ettinger

SSM Health Saint Louis University Hospital

Recruiting

St Louis, Missouri, United States, 63104

Contacts

Site Public Contact

314-977-4440

Principal Investigator:

Sean Massa

Nebraska Cancer Specialists/Oncology Hematology West PC - MECC

Recruiting

Omaha, Nebraska, United States, 68114

Contacts

Site Public Contact

402-334-4773

Principal Investigator:

Aru Panwar

Nebraska Methodist Hospital

Recruiting

Omaha, Nebraska, United States, 68114

Contacts

Site Public Contact

402-354-5144

Principal Investigator:

Aru Panwar

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Principal Investigator:

Joseph A. Paydarfar

Memorial Sloan Kettering Basking Ridge

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Jennifer R. Cracchiolo

Saint Barnabas Medical Center

Recruiting

Livingston, New Jersey, United States, 07039

Contacts

Principal Investigator:

Dylan F. Roden

Memorial Sloan Kettering Monmouth

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Jennifer R. Cracchiolo

Memorial Sloan Kettering Bergen

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Jennifer R. Cracchiolo

Rutgers Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08903

Contacts

Site Public Contact

732-235-7356

Principal Investigator:

Dylan F. Roden

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

Principal Investigator:

Ryan P. McSpadden

Memorial Sloan Kettering Commack

Recruiting

Commack, New York, United States, 11725

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Jennifer R. Cracchiolo

Memorial Sloan Kettering Westchester

Recruiting

Harrison, New York, United States, 10604

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Jennifer R. Cracchiolo

NYU Langone Hospital - Long Island

Recruiting

Mineola, New York, United States, 11501

Contacts

Principal Investigator:

Umamaheswar Duvvuri

Laura and Isaac Perlmutter Cancer Center at NYU Langone

Recruiting

New York, New York, United States, 10016

Contacts

Site Public Contact

CancerTrials@nyulangone.org

Principal Investigator:

Umamaheswar Duvvuri

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Jennifer R. Cracchiolo

Memorial Sloan Kettering Nassau

Recruiting

Uniondale, New York, United States, 11553

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Jennifer R. Cracchiolo

UNC Lineberger Comprehensive Cancer Center

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Principal Investigator:

Trevor Hackman

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Principal Investigator:

Jamie A. Ku

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Principal Investigator:

Amit Agrawal

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Principal Investigator:

Rusha J. Patel

Clackamas Radiation Oncology Center

Recruiting

Clackamas, Oregon, United States, 97015

Contacts

Principal Investigator:

Dan S. Zuckerman

Providence Portland Medical Center

Recruiting

Portland, Oregon, United States, 97213

Contacts

Principal Investigator:

Dan S. Zuckerman

Providence Saint Vincent Medical Center

Recruiting

Portland, Oregon, United States, 97225

Contacts

Principal Investigator:

Dan S. Zuckerman

Carlisle Regional Cancer Center

Recruiting

Carlisle, Pennsylvania, United States, 17015

Contacts

Principal Investigator:

Kevin J. Contrera

Geisinger Medical Center

Recruiting

Danville, Pennsylvania, United States, 17822

Contacts

Principal Investigator:

Nicholas Purdy

UPMC Hillman Cancer Center Erie

Recruiting

Erie, Pennsylvania, United States, 16505

Contacts

Principal Investigator:

Kevin J. Contrera

UPMC Cancer Center at UPMC Horizon

Recruiting

Farrell, Pennsylvania, United States, 16121

Contacts

Principal Investigator:

Kevin J. Contrera

UPMC Pinnacle Cancer Center/Community Osteopathic Campus

Recruiting

Harrisburg, Pennsylvania, United States, 17109

Contacts

Principal Investigator:

Kevin J. Contrera

Penn State Milton S Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033-0850

Contacts

Site Public Contact

717-531-3779CTO@hmc.psu.edu

Principal Investigator:

Neerav Goyal

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

Recruiting

Mechanicsburg, Pennsylvania, United States, 17050

Contacts

Principal Investigator:

Kevin J. Contrera

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Principal Investigator:

David M. Cognetti

UPMC-Magee Womens Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Site Public Contact

412-647-2811

Principal Investigator:

Kevin J. Contrera

University of Pittsburgh Cancer Institute (UPCI)

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Site Public Contact

412-647-8073

Principal Investigator:

Kevin J. Contrera

UPMC-Shadyside Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Site Public Contact

412-621-2334

Principal Investigator:

Kevin J. Contrera

UPMC Memorial

Recruiting

York, Pennsylvania, United States, 17408

Contacts

Site Public Contact

717-724-6760

Principal Investigator:

Kevin J. Contrera

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Principal Investigator:

Evan M. Graboyes

Avera Cancer Institute

Recruiting

Sioux Falls, South Dakota, United States, 57105

Contacts

Principal Investigator:

William C. Spanos

Methodist Hospital

Recruiting

Memphis, Tennessee, United States, 38104

Contacts

Site Public Contact

901-516-2579

Principal Investigator:

John P. Gleysteen

University of Tennessee Health Science Center

Recruiting

Memphis, Tennessee, United States, 38163

Contacts

Principal Investigator:

John P. Gleysteen

Vanderbilt University/Ingram Cancer Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Site Public Contact

800-811-8480

Principal Investigator:

Michael C. Topf

MD Anderson in The Woodlands

Recruiting

Conroe, Texas, United States, 77384

Contacts

Principal Investigator:

Karen Y. Choi

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Site Public Contact

713-798-1354burton@bcm.edu

Principal Investigator:

Vlad C. Sandulache

Michael E DeBakey VA Medical Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Site Public Contact

800-553-2278

Principal Investigator:

Vlad C. Sandulache

UT MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Karen Y. Choi

MD Anderson West Houston

Recruiting

Houston, Texas, United States, 77079

Contacts

Principal Investigator:

Karen Y. Choi

UT MD Anderson - League City

Recruiting

League City, Texas, United States, 77573

Contacts

Principal Investigator:

Karen Y. Choi

MD Anderson in Sugar Land

Recruiting

Sugar Land, Texas, United States, 77478

Contacts

Principal Investigator:

Karen Y. Choi

Central Vermont Medical Center/National Life Cancer Treatment

Recruiting

Berlin Corners, Vermont, United States, 05602

Contacts

Site Public Contact

802-225-5400

Principal Investigator:

Mirabelle Sajisevi

University of Vermont Medical Center

Recruiting

Burlington, Vermont, United States, 05401

Contacts

Site Public Contact

802-656-4101rpo@uvm.edu

Principal Investigator:

Mirabelle Sajisevi

University of Vermont and State Agricultural College

Recruiting

Burlington, Vermont, United States, 05405

Contacts

Site Public Contact

802-656-8990rpo@uvm.edu

Principal Investigator:

Mirabelle Sajisevi

Froedtert Menomonee Falls Hospital

Recruiting

Menomonee Falls, Wisconsin, United States, 53051

Contacts

Site Public Contact

262-257-5100

Principal Investigator:

Joseph Zenga

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Site Public Contact

414-805-3666

Principal Investigator:

Joseph Zenga

Froedtert and MCW Moorland Reserve Health Center

Recruiting

New Berlin, Wisconsin, United States, 53151

Contacts

Site Public Contact

414-805-0505

Principal Investigator:

Joseph Zenga

Drexel Town Square Health Center

Recruiting

Oak Creek, Wisconsin, United States, 53154

Contacts

Site Public Contact

414-805-0505

Principal Investigator:

Joseph Zenga

Froedtert West Bend Hospital/Kraemer Cancer Center

Recruiting

West Bend, Wisconsin, United States, 53095

Contacts

Site Public Contact

414-805-0505

Principal Investigator:

Joseph Zenga

University Health Network-Princess Margaret Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Principal Investigator:

John R. de Almeida

More Information

Sponsor

NRG Oncology

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by NRG Oncology on 2026-08-17.