Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection for Patients With Early-Stage Oral Cavity Cancer
Randomized Phase II/III Trial of Sentinel Lymph Node Biopsy Versus Elective Neck Dissection for Early-Stage Oral Cavity Cancer
3 other identifiers
interventional
686
2 countries
106
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2020
Longer than P75 for phase_2
106 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2020
CompletedFirst Posted
Study publicly available on registry
April 3, 2020
CompletedStudy Start
First participant enrolled
September 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 27, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 27, 2031
May 4, 2026
April 1, 2026
10.6 years
March 26, 2020
April 28, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Patient-reported neck and shoulder function (Phase II/III)
Will be evaluated and compared using the Neck Dissection Impairment Index (NDII), a 10-item tool between the two treatment arms. It is assumed that a 7.5-point between arm difference in the 6-month post-surgery NDII scores is clinically meaningful.
Before surgery (Baseline), 3 weeks after surgery, 3, 6, 12 months after surgery
Patient reported quality of life (QOL) (Phase II)
Will be measured using 3 questionnaires over 12-15 minutes.
Before surgery (Baseline), 3 weeks after surgery, 3, 6, 12 months after surgery
Disease-free survival (DFS) (phase III)
Measured using Cox proportional hazards model and the Kaplan-Meier method. Failure includes local/regional recurrence, distant metastasis, or death due to any cause.
From randomization to local/regional recurrence, distant metastasis, or death due to any cause, whichever comes first, assessed up to 11 years
Secondary Outcomes (11)
Overall survival rate
From randomization to death due to any cause, assessed up to 11 years
Loco-regional failure
From the time of randomization to the date of failure, date of precluding event, or last known follow-up date, assessed up to 11 years
Distant metastasis
From the time of randomization to the date of distant metastasis, date of precluding event, or last known follow-up date, assessed up to 11 years
Toxicity
Time of primary endpoint analysis
Patient-reported shoulder-related QOL, function impairment and disability
Baseline, 3 weeks, 3, 6, 12 months post-surgery
- +6 more secondary outcomes
Other Outcomes (2)
Quality of life
Baseline, 3 weeks, and 3, 6, 12 months post-surgery
DFS for low-risk patients
From randomization to local/regional recurrence, distant metastasis, or death due to any cause, whichever comes first, assessed up to 11 years
Study Arms (2)
Group I (SLN biopsy)
EXPERIMENTALPatients 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.
Group II (END)
ACTIVE COMPARATORPatients undergo standard END. Patients also undergo FDG PET/CT, CT, and/or chest x-ray at screening and during follow up.
Interventions
Undergo chest x-ray
Undergo SPECT/CT scan and FDG PET/CT or CT
Undergo FDG PET/CT
Receive imaging agent via injection
Undergo FDG PET/CT
Undergo SLN biopsy
Undergo SPECT/CT scan
Eligibility Criteria
You may qualify if:
- 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:
- +4 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NRG Oncologylead
- National Cancer Institute (NCI)collaborator
Study Sites (106)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, 85054, United States
Banner University Medical Center - Tucson
Tucson, Arizona, 85719, United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
UC San Diego Medical Center - Hillcrest
San Diego, California, 92103, United States
UCSF Medical Center-Mission Bay
San Francisco, California, 94158, United States
Stanford Cancer Center South Bay
San Jose, California, 95124, United States
Yale University
New Haven, Connecticut, 06520, United States
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, 06611, United States
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, 33146, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, 33442, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Northwestern University
Chicago, Illinois, 60611, United States
Rush MD Anderson Cancer Center
Chicago, Illinois, 60612, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Springfield Memorial Hospital
Springfield, Illinois, 62781, United States
Heartland Oncology and Hematology LLP
Council Bluffs, Iowa, 51503, United States
Methodist Jennie Edmundson Hospital
Council Bluffs, Iowa, 51503, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536, United States
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, 40202, United States
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana, 71103, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334, United States
Henry Ford Medical Center-Columbus
Novi, Michigan, 48377, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
SSM Health Saint Louis University Hospital
St Louis, Missouri, 63104, United States
Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
Omaha, Nebraska, 68114, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Oncology Associates PC
Omaha, Nebraska, 68114, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756, United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Saint Barnabas Medical Center
Livingston, New Jersey, 07039, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester
East White Plains, New York, 10604, United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042, United States
NYU Langone Hospital - Long Island
Mineola, New York, 11501, United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016, United States
Manhattan Eye Ear and Throat Hospital
New York, New York, 10065, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Lenox Hill Hospital
New York, New York, 10075, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Sanford Broadway Medical Center
Fargo, North Dakota, 58122, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015, United States
Providence Newberg Medical Center
Newberg, Oregon, 97132, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Providence Saint Vincent Medical Center
Portland, Oregon, 97225, United States
Carlisle Regional Cancer Center
Carlisle, Pennsylvania, 17015, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, 16505, United States
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania, 17109, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania, 17050, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232, United States
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, 15232, United States
UPMC Memorial
York, Pennsylvania, 17408, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
Methodist Hospital
Memphis, Tennessee, 38104, United States
University of Tennessee Health Science Center
Memphis, Tennessee, 38163, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
MD Anderson in The Woodlands
Conroe, Texas, 77384, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Michael E DeBakey VA Medical Center
Houston, Texas, 77030, United States
MD Anderson West Houston
Houston, Texas, 77079, United States
MD Anderson League City
League City, Texas, 77573, United States
MD Anderson in Sugar Land
Sugar Land, Texas, 77478, United States
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, 05602, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
University of Vermont and State Agricultural College
Burlington, Vermont, 05405, United States
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, 53051, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Froedtert and MCW Moorland Reserve Health Center
New Berlin, Wisconsin, 53151, United States
Drexel Town Square Health Center
Oak Creek, Wisconsin, 53154, United States
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin, 53095, United States
University Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen Y Lai
NRG Oncology
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2020
First Posted
April 3, 2020
Study Start
September 23, 2020
Primary Completion (Estimated)
April 27, 2031
Study Completion (Estimated)
April 27, 2031
Last Updated
May 4, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.