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

PHASE2/PHASE3SuspendedINTERVENTIONAL
Enrollment

686

Participants

Timeline

Start Date

September 23, 2020

Primary Completion Date

April 27, 2031

Study Completion Date

April 27, 2031

Conditions
Buccal Mucosa Squamous Cell CarcinomaFloor of Mouth Squamous Cell CarcinomaGingival Squamous Cell CarcinomaHard Palate Squamous Cell CarcinomaLip Squamous Cell CarcinomaLower Alveolar Ridge Squamous Cell CarcinomaOral Cavity Squamous Cell CarcinomaRetromolar Trigone Squamous Cell CarcinomaStage I Lip and Oral Cavity Cancer AJCC v8Stage II Lip and Oral Cavity Cancer AJCC v8Tongue Squamous Cell CarcinomaUpper 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

Trial Locations (97)

10016

Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York

10065

Manhattan Eye Ear and Throat Hospital, New York

Memorial Sloan Kettering Cancer Center, New York

10075

Lenox Hill Hospital, New York

10604

Memorial Sloan Kettering Westchester, Harrison

11040

Long Island Jewish Medical Center, New Hyde Park

11042

Northwell Health/Center for Advanced Medicine, Lake Success

11501

NYU Langone Hospital - Long Island, Mineola

11553

Memorial Sloan Kettering Nassau, Uniondale

11725

Memorial Sloan Kettering Commack, Commack

14263

Roswell Park Cancer Institute, Buffalo

15213

UPMC-Magee Womens Hospital, Pittsburgh

15232

University of Pittsburgh Cancer Institute (UPCI), Pittsburgh

UPMC-Shadyside Hospital, Pittsburgh

17015

Carlisle Regional Cancer Center, Carlisle

17050

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion, Mechanicsburg

17109

UPMC Pinnacle Cancer Center/Community Osteopathic Campus, Harrisburg

17408

UPMC Memorial, York

17822

Geisinger Medical Center, Danville

19107

Thomas Jefferson University Hospital, Philadelphia

19111

Fox Chase Cancer Center, Philadelphia

27599

UNC Lineberger Comprehensive Cancer Center, Chapel Hill

29425

Medical University of South Carolina, Charleston

30308

Emory University Hospital Midtown, Atlanta

30322

Emory University Hospital/Winship Cancer Institute, Atlanta

33136

University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami

33146

UM Sylvester Comprehensive Cancer Center at Coral Gables, Coral Gables

33442

UM Sylvester Comprehensive Cancer Center at Deerfield Beach, Deerfield Beach

35233

University of Alabama at Birmingham Cancer Center, Birmingham

37232

Vanderbilt University/Ingram Cancer Center, Nashville

38104

Methodist Hospital, Memphis

38163

University of Tennessee Health Science Center, Memphis

40202

The James Graham Brown Cancer Center at University of Louisville, Louisville

40536

University of Kentucky/Markey Cancer Center, Lexington

43210

Ohio State University Comprehensive Cancer Center, Columbus

44195

Cleveland Clinic Foundation, Cleveland

48109

University of Michigan Comprehensive Cancer Center, Ann Arbor

48201

Wayne State University/Karmanos Cancer Institute, Detroit

48202

Henry Ford Hospital, Detroit

48322

Henry Ford West Bloomfield Hospital, West Bloomfield

48334

Weisberg Cancer Treatment Center, Farmington Hills

48377

Henry Ford Medical Center-Columbus, Novi

52242

University of Iowa/Holden Comprehensive Cancer Center, Iowa City

55905

Mayo Clinic in Rochester, Rochester

57104

Sanford Cancer Center Oncology Clinic, Sioux Falls

57105

Avera Cancer Institute, Sioux Falls

58122

Sanford Broadway Medical Center, Fargo

Sanford Roger Maris Cancer Center, Fargo

60611

Northwestern University, Chicago

60612

Rush University Medical Center, Chicago

62702

Southern Illinois University School of Medicine, Springfield

62781

Springfield Memorial Hospital, Springfield

63104

SSM Health Saint Louis University Hospital, St Louis

66160

University of Kansas Cancer Center, Kansas City

66205

University of Kansas Hospital-Westwood Cancer Center, Westwood

68114

Nebraska Cancer Specialists/Oncology Hematology West PC - MECC, Omaha

Nebraska Methodist Hospital, Omaha

Oncology Associates PC, Omaha

71103

LSU Health Sciences Center at Shreveport, Shreveport

72205

University of Arkansas for Medical Sciences, Little Rock

73104

University of Oklahoma Health Sciences Center, Oklahoma City

77030

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston

M D Anderson Cancer Center, Houston

Michael E DeBakey VA Medical Center, Houston

77079

MD Anderson West Houston, Houston

77384

MD Anderson in The Woodlands, Conroe

77478

MD Anderson in Sugar Land, Sugar Land

77573

MD Anderson League City, League City

85054

Mayo Clinic Hospital in Arizona, Phoenix

85234

Banner MD Anderson Cancer Center, Gilbert

85719

Banner University Medical Center - Tucson, Tucson

University of Arizona Cancer Center-North Campus, Tucson

91010

City of Hope Comprehensive Cancer Center, Duarte

92093

UC San Diego Moores Cancer Center, La Jolla

94158

UCSF Medical Center-Mission Bay, San Francisco

94304

Stanford Cancer Institute Palo Alto, Palo Alto

95124

Stanford Cancer Center South Bay, San Jose

95817

University of California Davis Comprehensive Cancer Center, Sacramento

97015

Clackamas Radiation Oncology Center, Clackamas

97132

Providence Newberg Medical Center, Newberg

97213

Providence Portland Medical Center, Portland

97225

Providence Saint Vincent Medical Center, Portland

06520

Yale University, New Haven

06611

Smilow Cancer Hospital Care Center-Trumbull, Trumbull

02118

Boston Medical Center, Boston

03756

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon

07920

Memorial Sloan Kettering Basking Ridge, Basking Ridge

07039

Saint Barnabas Medical Center, Livingston

07748

Memorial Sloan Kettering Monmouth, Middletown

07645

Memorial Sloan Kettering Bergen, Montvale

08903

Rutgers Cancer Institute of New Jersey, New Brunswick

17033-0850

Penn State Milton S Hershey Medical Center, Hershey

57117-5134

Sanford USD Medical Center - Sioux Falls, Sioux Falls

05602

Central Vermont Medical Center/National Life Cancer Treatment, Berlin Corners

05401

University of Vermont Medical Center, Burlington

05405

University of Vermont and State Agricultural College, Burlington

M5G 2M9

University Health Network-Princess Margaret Hospital, Toronto

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

NRG Oncology

OTHER