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RECRUITING

NCT04333537

PHASE2/PHASE3

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

Sponsor: NRG Oncology

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

686

Start Date

2020-09-23

Completion Date

2031-04-27

Last Updated

2026-04-03

Healthy Volunteers

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

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

Locations (106)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, United States

Banner University Medical Center - Tucson

Tucson, Arizona, United States

University of Arizona Cancer Center-North Campus

Tucson, Arizona, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

UC San Diego Medical Center - Hillcrest

San Diego, California, United States

UCSF Medical Center-Mission Bay

San Francisco, California, United States

Stanford Cancer Center South Bay

San Jose, California, United States

Yale University

New Haven, Connecticut, United States

Smilow Cancer Hospital Care Center-Trumbull

Trumbull, Connecticut, United States

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Rush MD Anderson Cancer Center

Chicago, Illinois, United States

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Springfield Memorial Hospital

Springfield, Illinois, United States

Heartland Oncology and Hematology LLP

Council Bluffs, Iowa, United States

Methodist Jennie Edmundson Hospital

Council Bluffs, Iowa, United States

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, United States

University of Kansas Cancer Center

Kansas City, Kansas, United States

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, United States

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, United States

LSU Health Sciences Center at Shreveport

Shreveport, Louisiana, United States

Boston Medical Center

Boston, Massachusetts, United States

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Weisberg Cancer Treatment Center

Farmington Hills, Michigan, United States

Henry Ford Medical Center-Columbus

Novi, Michigan, United States

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

SSM Health Saint Louis University Hospital

St Louis, Missouri, United States

Nebraska Cancer Specialists/Oncology Hematology West PC - MECC

Omaha, Nebraska, United States

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Oncology Associates PC

Omaha, Nebraska, United States

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, United States

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Saint Barnabas Medical Center

Livingston, New Jersey, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Memorial Sloan Kettering Commack

Commack, New York, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Northwell Health/Center for Advanced Medicine

Lake Success, New York, United States

NYU Langone Hospital - Long Island

Mineola, New York, United States

Long Island Jewish Medical Center

New Hyde Park, New York, United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, United States

Manhattan Eye Ear and Throat Hospital

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Lenox Hill Hospital

New York, New York, United States

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Sanford Broadway Medical Center

Fargo, North Dakota, United States

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Clackamas Radiation Oncology Center

Clackamas, Oregon, United States

Providence Newberg Medical Center

Newberg, Oregon, United States

Providence Portland Medical Center

Portland, Oregon, United States

Providence Saint Vincent Medical Center

Portland, Oregon, United States

Carlisle Regional Cancer Center

Carlisle, Pennsylvania, United States

Geisinger Medical Center

Danville, Pennsylvania, United States

UPMC Hillman Cancer Center Erie

Erie, Pennsylvania, United States

UPMC Pinnacle Cancer Center/Community Osteopathic Campus

Harrisburg, Pennsylvania, United States

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, United States

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

Mechanicsburg, Pennsylvania, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

UPMC-Magee Womens Hospital

Pittsburgh, Pennsylvania, United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

UPMC-Shadyside Hospital

Pittsburgh, Pennsylvania, United States

UPMC Memorial

York, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, United States

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, United States

Methodist Hospital

Memphis, Tennessee, United States

University of Tennessee Health Science Center

Memphis, Tennessee, United States

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

MD Anderson in The Woodlands

Conroe, Texas, United States

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, United States

M D Anderson Cancer Center

Houston, Texas, United States

Michael E DeBakey VA Medical Center

Houston, Texas, United States

MD Anderson West Houston

Houston, Texas, United States

MD Anderson League City

League City, Texas, United States

MD Anderson in Sugar Land

Sugar Land, Texas, United States

Central Vermont Medical Center/National Life Cancer Treatment

Berlin Corners, Vermont, United States

University of Vermont Medical Center

Burlington, Vermont, United States

University of Vermont and State Agricultural College

Burlington, Vermont, United States

Froedtert Menomonee Falls Hospital

Menomonee Falls, Wisconsin, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Froedtert and MCW Moorland Reserve Health Center

New Berlin, Wisconsin, United States

Drexel Town Square Health Center

Oak Creek, Wisconsin, United States

Froedtert West Bend Hospital/Kraemer Cancer Center

West Bend, Wisconsin, United States

University Health Network-Princess Margaret Hospital

Toronto, Ontario, Canada

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (106)