Actively Recruiting
Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection for Patients With Early-Stage Oral Cavity Cancer
Led by NRG Oncology · Updated on 2026-05-04
686
Participants Needed
106
Research Sites
552 weeks
Total Duration
On this page
Sponsors
N
NRG Oncology
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection for Patients With Early-Stage Oral Cavity Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of squamous cell carcinoma of oral cavity sites including tongue, floor of mouth, lip, buccal mucosa, alveolar ridges, retromolar trigone, or hard palate
- Early-stage tumor classified as T1-2N0M0 based on physical exam and imaging within 42 days prior to registration
- Surgical candidate for SLN biopsy and possible neck dissection
- Age 18 or older
- Zubrod performance status 0-2 within 42 days prior to registration
- Negative pregnancy test for women of child-bearing potential within 42 days prior to registration
- Able to read and understand English or French
- FDG PET/CT scan showing no lymph node involvement prior to randomization
- Completion of Neck Dissection Impairment Index (NDII) questionnaire prior to randomization
You will not qualify if you...
- Clinical or radiologic evidence of regional or distant metastatic disease
- Prior invasive malignancy outside head and neck unless disease-free for at least 2 years
- Head and neck squamous cell carcinoma in oropharynx, nasopharynx, hypopharynx, or larynx
- Unable or unwilling to complete baseline NDII questionnaire
- Prior chemotherapy for this cancer
- Prior radiotherapy overlapping study cancer region
- Severe co-morbidities preventing neck dissection
- Pregnancy or breastfeeding
- Incomplete resection of oral cavity lesion with positive margins
- Prior surgery involving lateral neck that prevents dissection
- History of hematologic malignancy or active diseases causing lymphadenopathy
- Currently receiving systemic cytotoxic, immunosuppressive, or immunomodulatory therapy
- Participation in another investigational therapeutic trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 106 locations
1
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
Active, Not Recruiting
2
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Actively Recruiting
3
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, United States, 85054
Actively Recruiting
4
Banner University Medical Center - Tucson
Tucson, Arizona, United States, 85719
Suspended
5
University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States, 85719
Suspended
6
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Actively Recruiting
7
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Active, Not Recruiting
8
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
9
Stanford Cancer Institute Palo Alto
Palo Alto, California, United States, 94304
Actively Recruiting
10
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Active, Not Recruiting
11
UC San Diego Medical Center - Hillcrest
San Diego, California, United States, 92103
Actively Recruiting
12
UCSF Medical Center-Mission Bay
San Francisco, California, United States, 94158
Actively Recruiting
13
Stanford Cancer Center South Bay
San Jose, California, United States, 95124
Actively Recruiting
14
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
15
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, United States, 06611
Actively Recruiting
16
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States, 33146
Actively Recruiting
17
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States, 33442
Actively Recruiting
18
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
19
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Actively Recruiting
20
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
21
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
22
Rush MD Anderson Cancer Center
Chicago, Illinois, United States, 60612
Actively Recruiting
23
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
Suspended
24
Springfield Memorial Hospital
Springfield, Illinois, United States, 62781
Suspended
25
Heartland Oncology and Hematology LLP
Council Bluffs, Iowa, United States, 51503
Suspended
26
Methodist Jennie Edmundson Hospital
Council Bluffs, Iowa, United States, 51503
Actively Recruiting
27
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
Actively Recruiting
28
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
29
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States, 66205
Actively Recruiting
30
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States, 40536
Actively Recruiting
31
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States, 40202
Suspended
32
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana, United States, 71103
Suspended
33
Boston Medical Center
Boston, Massachusetts, United States, 02118
Suspended
34
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
35
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
36
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
37
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States, 48334
Actively Recruiting
38
Henry Ford Medical Center-Columbus
Novi, Michigan, United States, 48377
Actively Recruiting
39
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, United States, 48322
Actively Recruiting
40
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
41
SSM Health Saint Louis University Hospital
St Louis, Missouri, United States, 63104
Actively Recruiting
42
Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
Omaha, Nebraska, United States, 68114
Actively Recruiting
43
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
Actively Recruiting
44
Oncology Associates PC
Omaha, Nebraska, United States, 68114
Suspended
45
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
46
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
47
Saint Barnabas Medical Center
Livingston, New Jersey, United States, 07039
Actively Recruiting
48
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
Actively Recruiting
49
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
Actively Recruiting
50
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
51
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
52
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
Actively Recruiting
53
Memorial Sloan Kettering Westchester
East White Plains, New York, United States, 10604
Actively Recruiting
54
Northwell Health/Center for Advanced Medicine
Lake Success, New York, United States, 11042
Active, Not Recruiting
55
NYU Langone Hospital - Long Island
Mineola, New York, United States, 11501
Actively Recruiting
56
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Active, Not Recruiting
57
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States, 10016
Actively Recruiting
58
Manhattan Eye Ear and Throat Hospital
New York, New York, United States, 10065
Active, Not Recruiting
59
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
60
Lenox Hill Hospital
New York, New York, United States, 10075
Active, Not Recruiting
61
Memorial Sloan Kettering Nassau
Uniondale, New York, United States, 11553
Actively Recruiting
62
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
63
Sanford Broadway Medical Center
Fargo, North Dakota, United States, 58122
Suspended
64
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States, 58122
Suspended
65
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
66
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
67
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
68
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States, 97015
Actively Recruiting
69
Providence Newberg Medical Center
Newberg, Oregon, United States, 97132
Suspended
70
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Actively Recruiting
71
Providence Saint Vincent Medical Center
Portland, Oregon, United States, 97225
Actively Recruiting
72
Carlisle Regional Cancer Center
Carlisle, Pennsylvania, United States, 17015
Actively Recruiting
73
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Actively Recruiting
74
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, United States, 16505
Actively Recruiting
75
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania, United States, 17109
Actively Recruiting
76
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Actively Recruiting
77
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania, United States, 17050
Actively Recruiting
78
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
79
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Active, Not Recruiting
80
UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
81
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
82
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
83
UPMC Memorial
York, Pennsylvania, United States, 17408
Actively Recruiting
84
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
85
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, United States, 57104
Suspended
86
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Actively Recruiting
87
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
Suspended
88
Methodist Hospital
Memphis, Tennessee, United States, 38104
Actively Recruiting
89
University of Tennessee Health Science Center
Memphis, Tennessee, United States, 38163
Actively Recruiting
90
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
91
MD Anderson in The Woodlands
Conroe, Texas, United States, 77384
Actively Recruiting
92
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
93
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
94
Michael E DeBakey VA Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
95
MD Anderson West Houston
Houston, Texas, United States, 77079
Actively Recruiting
96
MD Anderson League City
League City, Texas, United States, 77573
Actively Recruiting
97
MD Anderson in Sugar Land
Sugar Land, Texas, United States, 77478
Actively Recruiting
98
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, United States, 05602
Actively Recruiting
99
University of Vermont Medical Center
Burlington, Vermont, United States, 05401
Actively Recruiting
100
University of Vermont and State Agricultural College
Burlington, Vermont, United States, 05405
Actively Recruiting
101
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, United States, 53051
Actively Recruiting
102
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
103
Froedtert and MCW Moorland Reserve Health Center
New Berlin, Wisconsin, United States, 53151
Actively Recruiting
104
Drexel Town Square Health Center
Oak Creek, Wisconsin, United States, 53154
Actively Recruiting
105
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin, United States, 53095
Actively Recruiting
106
University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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