Less neck surgery may spare shoulder function in oral cancer patients

NCT ID NCT04333537

Disease control Sponsor: NRG Oncology Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 18, 2026 · Updated 2 times

Summary

This study tests whether a less invasive surgery called sentinel lymph node biopsy can replace standard neck dissection for early-stage oral cavity cancer. About 686 patients will be randomly assigned to one of the two procedures. The goal is to see if the gentler approach maintains cancer control while improving shoulder function and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: sentinel lymph node biopsy surgery
What this could lead to: If successful, this could show that a less invasive surgery works just as well as standard neck dissection, with better shoulder function and quality of life for patients.
What could go wrong: This is a large trial still recruiting, so results are years away. The less invasive approach may not control cancer as effectively, and individual outcomes vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 686 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2020

Expected to finish

Apr 2036

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

carcinoma of hard palate gingival cancer lip and oral cavity carcinoma Mouth Neoplasms oral cavity squamous cell carcinoma retromolar area cancer squamous cell carcinoma of buccal mucosa squamous cell carcinoma of floor of mouth Squamous Cell Carcinoma of Head and Neck squamous cell carcinoma of lip tongue squamous cell carcinoma upper gum cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

The study's own enquiry address

This study publishes an address for enquiries. See it below .
The places running it

99 sites in 2 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Show contact details

Locations

Avera Cancer Institute
RECRUITING

Sioux Falls, South Dakota, 57105, United States

Contact Email: •••••@•••••
Banner MD Anderson Cancer Center
RECRUITING

Gilbert, Arizona, 85234, United States
Banner University Medical Center - Tucson
RECRUITING

Tucson, Arizona, 85719, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
RECRUITING

Houston, Texas, 77030, United States
Boston Medical Center
SUSPENDED

Boston, Massachusetts, 02118, United States
Carlisle Regional Cancer Center
RECRUITING

Carlisle, Pennsylvania, 17015, United States
Central Vermont Medical Center/National Life Cancer Treatment
RECRUITING

Berlin Corners, Vermont, 05602, United States
City of Hope Comprehensive Cancer Center
ACTIVE_NOT_RECRUITING

Duarte, California, 91010, United States
Clackamas Radiation Oncology Center
RECRUITING

Clackamas, Oregon, 97015, United States

Contact Email: •••••@•••••
Cleveland Clinic Foundation
RECRUITING

Cleveland, Ohio, 44195, United States

Contact Email: •••••@•••••
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
RECRUITING

Lebanon, New Hampshire, 03756, United States
Drexel Town Square Health Center
RECRUITING

Oak Creek, Wisconsin, 53154, United States
Emory University Hospital Midtown
RECRUITING

Atlanta, Georgia, 30308, United States
Emory University Hospital/Winship Cancer Institute
RECRUITING

Atlanta, Georgia, 30322, United States
Fox Chase Cancer Center
ACTIVE_NOT_RECRUITING

Philadelphia, Pennsylvania, 19111, United States
Froedtert Menomonee Falls Hospital
RECRUITING

Menomonee Falls, Wisconsin, 53051, United States
Froedtert West Bend Hospital/Kraemer Cancer Center
RECRUITING

West Bend, Wisconsin, 53095, United States
Froedtert and MCW Moorland Reserve Health Center
RECRUITING

New Berlin, Wisconsin, 53151, United States
Geisinger Medical Center
RECRUITING

Danville, Pennsylvania, 17822, United States

Contact Email: •••••@•••••
Heartland Oncology and Hematology LLP
RECRUITING

Council Bluffs, Iowa, 51503, United States
Henry Ford Hospital
RECRUITING

Detroit, Michigan, 48202, United States

Contact Email: •••••@•••••
Henry Ford Medical Center-Columbus
RECRUITING

Novi, Michigan, 48377, United States

Contact Email: •••••@•••••
Henry Ford West Bloomfield Hospital
RECRUITING

West Bloomfield, Michigan, 48322, United States

Contact Email: •••••@•••••
LSU Health Sciences Center at Shreveport
SUSPENDED

Shreveport, Louisiana, 71103, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
RECRUITING

New York, New York, 10016, United States

Contact Email: •••••@•••••
Lenox Hill Hospital
ACTIVE_NOT_RECRUITING

New York, New York, 10075, United States
Long Island Jewish Medical Center
ACTIVE_NOT_RECRUITING

New Hyde Park, New York, 11040, United States
MD Anderson West Houston
RECRUITING

Houston, Texas, 77079, United States
MD Anderson in Sugar Land
RECRUITING

Sugar Land, Texas, 77478, United States
MD Anderson in The Woodlands
RECRUITING

Conroe, Texas, 77384, United States
Manhattan Eye Ear and Throat Hospital
ACTIVE_NOT_RECRUITING

New York, New York, 10065, United States
Mayo Clinic Hospital in Arizona
RECRUITING

Phoenix, Arizona, 85054, United States
Mayo Clinic in Rochester
RECRUITING

Rochester, Minnesota, 55905, United States
Medical College of Wisconsin
RECRUITING

Milwaukee, Wisconsin, 53226, United States
Medical University of South Carolina
RECRUITING

Charleston, South Carolina, 29425, United States
Memorial Sloan Kettering Basking Ridge
RECRUITING

Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Bergen
RECRUITING

Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Cancer Center
RECRUITING

New York, New York, 10065, United States
Memorial Sloan Kettering Commack
RECRUITING

Commack, New York, 11725, United States
Memorial Sloan Kettering Monmouth
RECRUITING

Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Nassau
RECRUITING

Uniondale, New York, 11553, United States
Memorial Sloan Kettering Westchester
RECRUITING

Harrison, New York, 10604, United States
Methodist Hospital
RECRUITING

Memphis, Tennessee, 38104, United States
Methodist Jennie Edmundson Hospital
RECRUITING

Council Bluffs, Iowa, 51503, United States
Michael E DeBakey VA Medical Center
RECRUITING

Houston, Texas, 77030, United States
NYU Langone Hospital - Long Island
RECRUITING

Mineola, New York, 11501, United States

Contact Email: •••••@•••••
Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
RECRUITING

Omaha, Nebraska, 68114, United States
Nebraska Methodist Hospital
RECRUITING

Omaha, Nebraska, 68114, United States
Northwell Health/Center for Advanced Medicine
ACTIVE_NOT_RECRUITING

Lake Success, New York, 11042, United States
Northwestern University
RECRUITING

Chicago, Illinois, 60611, United States

Contact Email: •••••@•••••
Ohio State University Comprehensive Cancer Center
RECRUITING

Columbus, Ohio, 43210, United States
Oncology Associates PC
SUSPENDED

Omaha, Nebraska, 68114, United States
Penn State Milton S Hershey Medical Center
RECRUITING

Hershey, Pennsylvania, 17033-0850, United States
Providence Newberg Medical Center
SUSPENDED

Newberg, Oregon, 97132, United States
Providence Portland Medical Center
RECRUITING

Portland, Oregon, 97213, United States

Contact Email: •••••@•••••
Providence Saint Vincent Medical Center
RECRUITING

Portland, Oregon, 97225, United States

Contact Email: •••••@•••••
Roswell Park Cancer Institute
RECRUITING

Buffalo, New York, 14263, United States
Rush MD Anderson Cancer Center
RECRUITING

Chicago, Illinois, 60612, United States

Contact Email: •••••@•••••
Rutgers Cancer Institute of New Jersey
RECRUITING

New Brunswick, New Jersey, 08903, United States
SSM Health Saint Louis University Hospital
RECRUITING

St Louis, Missouri, 63104, United States
Saint Barnabas Medical Center
RECRUITING

Livingston, New Jersey, 07039, United States
Sanford Broadway Medical Center
SUSPENDED

Fargo, North Dakota, 58122, United States
Sanford Cancer Center Oncology Clinic
SUSPENDED

Sioux Falls, South Dakota, 57104, United States
Sanford Roger Maris Cancer Center
SUSPENDED

Fargo, North Dakota, 58122, United States
Sanford USD Medical Center - Sioux Falls
SUSPENDED

Sioux Falls, South Dakota, 57117-5134, United States
Smilow Cancer Hospital Care Center-Trumbull
RECRUITING

Trumbull, Connecticut, 06611, United States

Contact Email: •••••@•••••
Southern Illinois University School of Medicine
SUSPENDED

Springfield, Illinois, 62702, United States
Springfield Memorial Hospital
SUSPENDED

Springfield, Illinois, 62781, United States
Stanford Cancer Center South Bay
RECRUITING

San Jose, California, 95124, United States
Stanford Cancer Institute Palo Alto
RECRUITING

Palo Alto, California, 94304, United States
The James Graham Brown Cancer Center at University of Louisville
SUSPENDED

Louisville, Kentucky, 40202, United States
Thomas Jefferson University Hospital
RECRUITING

Philadelphia, Pennsylvania, 19107, United States

Contact Email: •••••@•••••
UC San Diego Medical Center - Hillcrest
RECRUITING

San Diego, California, 92103, United States
UC San Diego Moores Cancer Center
RECRUITING

La Jolla, California, 92093, United States

Contact Email: •••••@•••••
UCSF Medical Center-Mission Bay
RECRUITING

San Francisco, California, 94158, United States

Contact Email: •••••@•••••
UM Sylvester Comprehensive Cancer Center at Coral Gables
RECRUITING

Coral Gables, Florida, 33146, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
RECRUITING

Deerfield Beach, Florida, 33442, United States
UNC Lineberger Comprehensive Cancer Center
RECRUITING

Chapel Hill, North Carolina, 27599, United States

Contact Email: •••••@•••••
UPMC Cancer Center at UPMC Horizon
RECRUITING

Farrell, Pennsylvania, 16121, United States
UPMC Hillman Cancer Center Erie
RECRUITING

Erie, Pennsylvania, 16505, United States

Contact Email: •••••@•••••
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
RECRUITING

Mechanicsburg, Pennsylvania, 17050, United States
UPMC Memorial
RECRUITING

York, Pennsylvania, 17408, United States
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
RECRUITING

Harrisburg, Pennsylvania, 17109, United States
UPMC-Magee Womens Hospital
RECRUITING

Pittsburgh, Pennsylvania, 15213, United States
UPMC-Shadyside Hospital
RECRUITING

Pittsburgh, Pennsylvania, 15232, United States
UT MD Anderson - League City
RECRUITING

League City, Texas, 77573, United States
UT MD Anderson Cancer Center
RECRUITING

Houston, Texas, 77030, United States
University Health Network-Princess Margaret Hospital
RECRUITING

Toronto, Ontario, M5G 2M9, Canada

Contact Email: •••••@•••••
University of Alabama at Birmingham Cancer Center
WITHDRAWN

Birmingham, Alabama, 35233, United States
University of Arizona Cancer Center-North Campus
RECRUITING

Tucson, Arizona, 85719, United States
University of Arkansas for Medical Sciences
RECRUITING

Little Rock, Arkansas, 72205, United States
University of California Davis Comprehensive Cancer Center
ACTIVE_NOT_RECRUITING

Sacramento, California, 95817, United States
University of Iowa/Holden Comprehensive Cancer Center
RECRUITING

Iowa City, Iowa, 52242, United States
University of Kansas Cancer Center
RECRUITING

Kansas City, Kansas, 66160, United States
University of Kansas Hospital-Westwood Cancer Center
RECRUITING

Westwood, Kansas, 66205, United States
University of Kentucky/Markey Cancer Center
RECRUITING

Lexington, Kentucky, 40536, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
RECRUITING

Miami, Florida, 33136, United States
University of Michigan Rogel Cancer Center
RECRUITING

Ann Arbor, Michigan, 48109, United States

Contact Email: •••••@•••••
University of Oklahoma Health Sciences Center
RECRUITING

Oklahoma City, Oklahoma, 73104, United States
University of Pittsburgh Cancer Institute (UPCI)
RECRUITING

Pittsburgh, Pennsylvania, 15232, United States
University of Tennessee Health Science Center
RECRUITING

Memphis, Tennessee, 38163, United States
University of Vermont Medical Center
RECRUITING

Burlington, Vermont, 05401, United States
University of Vermont and State Agricultural College
RECRUITING

Burlington, Vermont, 05405, United States
Vanderbilt University/Ingram Cancer Center
RECRUITING

Nashville, Tennessee, 37232, United States
Wayne State University/Karmanos Cancer Institute
RECRUITING

Detroit, Michigan, 48201, United States

Contact Email: •••••@•••••
Weisberg Cancer Treatment Center
RECRUITING

Farmington Hills, Michigan, 48334, United States

Contact Email: •••••@•••••
Yale University
RECRUITING

New Haven, Connecticut, 06520, United States

Contact Email: •••••@•••••

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