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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group I (SLN biopsy) 		Patients 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.
  • Procedure: Chest Radiography
    Undergo chest x-ray
    Other names:
    • Chest X-ray
  • Procedure: Computed Tomography
    Undergo SPECT/CT scan and FDG PET/CT or CT
    Other names:
    • CAT
    • CAT Scan
    • Computed Axial Tomography
    • Computerized Axial Tomography
    • Computerized axial tomography (procedure)
    • Computerized Tomography
    • Computerized Tomography (CT) scan
    • CT
    • CT Scan
    • tomography
  • Other: Fludeoxyglucose F-18
    Undergo FDG PET/CT
    Other names:
    • 18FDG
    • FDG
    • Fludeoxyglucose (18F)
    • fludeoxyglucose F 18
    • Fludeoxyglucose F18
    • Fluorine-18 2-Fluoro-2-deoxy-D-Glucose
    • Fluorodeoxyglucose F18
  • Drug: Imaging Agent
    Receive imaging agent via injection
    Other names:
    • Image Enhancement Agent
  • Procedure: Planar Imaging
    Undergo planar imaging
  • Procedure: Positron Emission Tomography
    Undergo FDG PET/CT
    Other names:
    • Medical Imaging, Positron Emission Tomography
    • PET
    • PET Scan
    • Positron emission tomography (procedure)
    • Positron Emission Tomography Scan
    • Positron-Emission Tomography
    • PT
  • Other: Questionnaire Administration
    Ancillary studies
  • Procedure: Sentinel Lymph Node Biopsy
    Undergo SLN biopsy
    Other names:
    • Sentinel Node Biopsy
    • Sentinel node biopsy alone
    • SLNB
    • SNB
  • Procedure: Single Photon Emission Computed Tomography
    Undergo SPECT/CT scan
    Other names:
    • Medical Imaging, Single Photon Emission Computed Tomography
    • Single Photon Emission Tomography
    • Single-Photon Emission Computed
    • single-photon emission computed tomography
    • SPECT
    • SPECT imaging
    • SPECT SCAN
    • SPET
    • ST
    • tomography, emission computed, single photon
    • Tomography, Emission-Computed, Single-Photon
Active Comparator
Group II (END) 		Patients undergo standard END. Patients also undergo FDG PET/CT, CT, and/or chest x-ray at screening and during follow up.
  • Procedure: Chest Radiography
    Undergo chest x-ray
    Other names:
    • Chest X-ray
  • Other: Fludeoxyglucose F-18
    Undergo FDG PET/CT
    Other names:
    • 18FDG
    • FDG
    • Fludeoxyglucose (18F)
    • fludeoxyglucose F 18
    • Fludeoxyglucose F18
    • Fluorine-18 2-Fluoro-2-deoxy-D-Glucose
    • Fluorodeoxyglucose F18
  • Procedure: Neck Dissection
    Undergo standard elective neck dissection
  • Procedure: Positron Emission Tomography
    Undergo FDG PET/CT
    Other names:
    • Medical Imaging, Positron Emission Tomography
    • PET
    • PET Scan
    • Positron emission tomography (procedure)
    • Positron Emission Tomography Scan
    • Positron-Emission Tomography
    • PT
  • Other: Questionnaire Administration
    Ancillary studies

Recruiting Locations

University of Alabama at Birmingham Cancer Center
Birmingham 4049979, Alabama 4829764 35233
Contact:
Site Public Contact
205-934-0220
tmyrick@uab.edu

Banner MD Anderson Cancer Center
Gilbert 5295903, Arizona 5551752 85234
Contact:
Site Public Contact
602-747-9738

Mayo Clinic Hospital in Arizona
Phoenix 5308655, Arizona 5551752 85054
Contact:
Site Public Contact
855-776-0015

Banner University Medical Center - Tucson
Tucson 5318313, Arizona 5551752 85719
Contact:
Site Public Contact
UACC-IIT@uacc.arizona.edu

University of Arizona Cancer Center-North Campus
Tucson 5318313, Arizona 5551752 85719
Contact:
Site Public Contact
UACC-IIT@uacc.arizona.edu

University of Arkansas for Medical Sciences
Little Rock 4119403, Arkansas 4099753 72205
Contact:
Site Public Contact
501-686-8274

City of Hope Comprehensive Cancer Center
Duarte 5344147, California 5332921 91010
Contact:
Site Public Contact
800-826-4673
becomingapatient@coh.org

UC San Diego Moores Cancer Center
La Jolla 5363943, California 5332921 92093
Contact:
Site Public Contact
858-822-5354
cancercto@ucsd.edu

Stanford Cancer Institute Palo Alto
Palo Alto 5380748, California 5332921 94304
Contact:
Site Public Contact
650-498-7061
ccto-office@stanford.edu

University of California Davis Comprehensive Cancer Center
Sacramento 5389489, California 5332921 95817
Contact:
Site Public Contact
916-734-3089

UCSF Medical Center-Mission Bay
San Francisco 5391959, California 5332921 94158
Contact:
Site Public Contact
877-827-3222
cancertrials@ucsf.edu

Stanford Cancer Center South Bay
San Jose 5392171, California 5332921 95124
Contact:
Site Public Contact
650-498-7061
ccto-office@stanford.edu

Yale University
New Haven 4839366, Connecticut 4831725 06520
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital Care Center-Trumbull
Trumbull 4844459, Connecticut 4831725 06611
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables 4151871, Florida 4155751 33146
Contact:
Site Public Contact
305-243-2647

UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach 4153071, Florida 4155751 33442
Contact:
Site Public Contact
305-243-2647

University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami 4164138, Florida 4155751 33136
Contact:
Site Public Contact
305-243-2647

Emory University Hospital Midtown
Atlanta 4180439, Georgia 4197000 30308
Contact:
Site Public Contact
888-946-7447

Emory University Hospital/Winship Cancer Institute
Atlanta 4180439, Georgia 4197000 30322
Contact:
Site Public Contact
404-778-1868

Northwestern University
Chicago 4887398, Illinois 4896861 60611
Contact:
Site Public Contact
312-695-1301
cancer@northwestern.edu

Rush University Medical Center
Chicago 4887398, Illinois 4896861 60612
Contact:
Site Public Contact
312-942-5498
clinical_trials@rush.edu

Southern Illinois University School of Medicine
Springfield 4250542, Illinois 4896861 62702
Contact:
Site Public Contact
217-545-7929

Springfield Memorial Hospital
Springfield 4250542, Illinois 4896861 62781
Contact:
Site Public Contact
217-528-7541
pallante.beth@mhsil.com

University of Iowa/Holden Comprehensive Cancer Center
Iowa City 4862034, Iowa 4862182 52242
Contact:
Site Public Contact
800-237-1225

University of Kansas Cancer Center
Kansas City 4273837, Kansas 4273857 66160
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

University of Kansas Hospital-Westwood Cancer Center
Westwood 4281639, Kansas 4273857 66205
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

University of Kentucky/Markey Cancer Center
Lexington 4297983, Kentucky 6254925 40536
Contact:
Site Public Contact
859-257-3379

The James Graham Brown Cancer Center at University of Louisville
Louisville 4299276, Kentucky 6254925 40202
Contact:
Site Public Contact
502-562-3429

LSU Health Sciences Center at Shreveport
Shreveport 4341513, Louisiana 4331987 71103
Contact:
Site Public Contact
318-813-1404
LPost@lsuhsc.edu

Boston Medical Center
Boston 4930956, Massachusetts 6254926 02118
Contact:
Site Public Contact
617-638-8265

University of Michigan Comprehensive Cancer Center
Ann Arbor 4984247, Michigan 5001836 48109
Contact:
Site Public Contact
slusserb@med.umich.edu

Wayne State University/Karmanos Cancer Institute
Detroit 4990729, Michigan 5001836 48201
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

Henry Ford Hospital
Detroit 4990729, Michigan 5001836 48202
Contact:
Site Public Contact
313-916-3721
CTOResearch@hfhs.org

Weisberg Cancer Treatment Center
Farmington Hills 4992523, Michigan 5001836 48334
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

Henry Ford Medical Center-Columbus
Novi 5004062, Michigan 5001836 48377
Contact:
Site Public Contact
313-916-3721
CTOResearch@hfhs.org

Henry Ford West Bloomfield Hospital
West Bloomfield 7259621, Michigan 5001836 48322
Contact:
Site Public Contact
313-916-3721
CTOResearch@hfhs.org

Mayo Clinic in Rochester
Rochester 5043473, Minnesota 5037779 55905
Contact:
Site Public Contact
855-776-0015

SSM Health Saint Louis University Hospital
St Louis 4407066, Missouri 4398678 63104
Contact:
Site Public Contact
314-977-4440

Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
Omaha 5074472, Nebraska 5073708 68114
Contact:
Site Public Contact
402-334-4773

Nebraska Methodist Hospital
Omaha 5074472, Nebraska 5073708 68114
Contact:
Site Public Contact
402-354-5144

Oncology Associates PC
Omaha 5074472, Nebraska 5073708 68114
Contact:
Site Public Contact
402-354-5860
info@oa-oc.com

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon 5088597, New Hampshire 5090174 03756
Contact:
Site Public Contact
800-639-6918
cancer.research.nurse@dartmouth.edu

Memorial Sloan Kettering Basking Ridge
Basking Ridge 5095409, New Jersey 5101760 07920
Contact:
Site Public Contact
212-639-7592

Saint Barnabas Medical Center
Livingston 5100572, New Jersey 5101760 07039
Contact:
Site Public Contact
973-322-2934
joanne.loeb@rwjbh.org

Memorial Sloan Kettering Monmouth
Middletown 5101170, New Jersey 5101760 07748
Contact:
Site Public Contact
212-639-7592

Memorial Sloan Kettering Bergen
Montvale 5101361, New Jersey 5101760 07645
Contact:
Site Public Contact
212-639-7592

Rutgers Cancer Institute of New Jersey
New Brunswick 5101717, New Jersey 5101760 08903
Contact:
Site Public Contact
732-235-7356

Roswell Park Cancer Institute
Buffalo 5110629, New York 5128638 14263
Contact:
Site Public Contact
800-767-9355
askroswell@roswellpark.org

Memorial Sloan Kettering Commack
Commack 5113412, New York 5128638 11725
Contact:
Site Public Contact
212-639-7592

Memorial Sloan Kettering Westchester
Harrison 5120095, New York 5128638 10604
Contact:
Site Public Contact
212-639-7592

Northwell Health/Center for Advanced Medicine
Lake Success 5123853, New York 5128638 11042
Contact:
Site Public Contact
516-734-8896

NYU Langone Hospital - Long Island
Mineola 5127134, New York 5128638 11501
Contact:
Site Public Contact
212-263-4432
cancertrials@nyulangone.org

Long Island Jewish Medical Center
New Hyde Park 5128514, New York 5128638 11040
Contact:
Site Public Contact
516-734-8896

Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York 5128581, New York 5128638 10016
Contact:
Site Public Contact
CancerTrials@nyulangone.org

Manhattan Eye Ear and Throat Hospital
New York 5128581, New York 5128638 10065
Contact:
Site Public Contact
212-434-4460

Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638 10065
Contact:
Site Public Contact
212-639-7592

Lenox Hill Hospital
New York 5128581, New York 5128638 10075
Contact:
Site Public Contact
516-734-8896

Memorial Sloan Kettering Nassau
Uniondale 5141927, New York 5128638 11553
Contact:
Site Public Contact
212-639-7592

UNC Lineberger Comprehensive Cancer Center
Chapel Hill 4460162, North Carolina 4482348 27599
Contact:
Site Public Contact
877-668-0683
cancerclinicaltrials@med.unc.edu

Sanford Broadway Medical Center
Fargo 5059163, North Dakota 5690763 58122
Contact:
Site Public Contact
701-323-5760
OncologyClinicalTrialsFargo@sanfordhealth.org

Sanford Roger Maris Cancer Center
Fargo 5059163, North Dakota 5690763 58122
Contact:
Site Public Contact
701-234-6161
OncologyClinicalTrialsFargo@sanfordhealth.org

Cleveland Clinic Foundation
Cleveland 5150529, Ohio 5165418 44195
Contact:
Site Public Contact
866-223-8100
TaussigResearch@ccf.org

Ohio State University Comprehensive Cancer Center
Columbus 4509177, Ohio 5165418 43210
Contact:
Site Public Contact
800-293-5066
Jamesline@osumc.edu

University of Oklahoma Health Sciences Center
Oklahoma City 4544349, Oklahoma 4544379 73104
Contact:
Site Public Contact
405-271-8777
ou-clinical-trials@ouhsc.edu

Clackamas Radiation Oncology Center
Clackamas 5719308, Oregon 5744337 97015
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Providence Newberg Medical Center
Newberg 5742726, Oregon 5744337 97132
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Providence Portland Medical Center
Portland 5746545, Oregon 5744337 97213
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Providence Saint Vincent Medical Center
Portland 5746545, Oregon 5744337 97225
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Carlisle Regional Cancer Center
Carlisle 5183234, Pennsylvania 6254927 17015
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

Geisinger Medical Center
Danville 5186327, Pennsylvania 6254927 17822
Contact:
Site Public Contact
570-271-5251
HemonCCTrials@geisinger.edu

UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg 5192726, Pennsylvania 6254927 17109
Contact:
Site Public Contact
717-724-6765
klitchfield@PINNACLEHEALTH.org

Penn State Milton S Hershey Medical Center
Hershey 5193342, Pennsylvania 6254927 17033-0850
Contact:
Site Public Contact
717-531-3779
CTO@hmc.psu.edu

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg 5200657, Pennsylvania 6254927 17050
Contact:
Site Public Contact
412-389-5208
haneydl@upmc.edu

Thomas Jefferson University Hospital
Philadelphia 4560349, Pennsylvania 6254927 19107
Contact:
Site Public Contact
215-600-9151
ONCTrialNow@jefferson.edu

Fox Chase Cancer Center
Philadelphia 4560349, Pennsylvania 6254927 19111
Contact:
Site Public Contact
215-728-4790

UPMC-Magee Womens Hospital
Pittsburgh 5206379, Pennsylvania 6254927 15213
Contact:
Site Public Contact
412-647-2811

University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh 5206379, Pennsylvania 6254927 15232
Contact:
Site Public Contact
412-647-8073

UPMC-Shadyside Hospital
Pittsburgh 5206379, Pennsylvania 6254927 15232
Contact:
Site Public Contact
412-621-2334

UPMC Memorial
York 4562407, Pennsylvania 6254927 17408
Contact:
Site Public Contact
717-724-6760

Medical University of South Carolina
Charleston 4574324, South Carolina 4597040 29425
Contact:
Site Public Contact
843-792-9321
hcc-clinical-trials@musc.edu

Sanford Cancer Center Oncology Clinic
Sioux Falls 5231851, South Dakota 5769223 57104
Contact:
Site Public Contact
605-312-3320
OncologyClinicTrialsSF@sanfordhealth.org

Avera Cancer Institute
Sioux Falls 5231851, South Dakota 5769223 57105
Contact:
Site Public Contact
605-322-3095
OncRegulatory@avera.org

Sanford USD Medical Center - Sioux Falls
Sioux Falls 5231851, South Dakota 5769223 57117-5134
Contact:
Site Public Contact
605-312-3320
OncologyClinicalTrialsSF@SanfordHealth.org

Methodist Hospital
Memphis 4641239, Tennessee 4662168 38104
Contact:
Site Public Contact
901-516-2579

University of Tennessee Health Science Center
Memphis 4641239, Tennessee 4662168 38163
Contact:
Site Public Contact
901-683-0055
afletcher@westclinic.com

Vanderbilt University/Ingram Cancer Center
Nashville 4644585, Tennessee 4662168 37232
Contact:
Site Public Contact
800-811-8480

MD Anderson in The Woodlands
Conroe 4682991, Texas 4736286 77384
Contact:
Site Public Contact
866-632-6789
askmdanderson@mdanderson.org

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston 4699066, Texas 4736286 77030
Contact:
Site Public Contact
713-798-1354
burton@bcm.edu

M D Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
Contact:
Site Public Contact
877-632-6789
askmdanderson@mdanderson.org

Michael E DeBakey VA Medical Center
Houston 4699066, Texas 4736286 77030
Contact:
Site Public Contact
800-553-2278

MD Anderson West Houston
Houston 4699066, Texas 4736286 77079
Contact:
Site Public Contact
877-632-6789
askmdanderson@mdanderson.org

MD Anderson League City
League City 4705692, Texas 4736286 77573
Contact:
Site Public Contact
877-632-6789
askmdanderson@mdanderson.org

MD Anderson in Sugar Land
Sugar Land 4734825, Texas 4736286 77478
Contact:
Site Public Contact
877-632-6789
askmdanderson@mdanderson.org

Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners 5233780, Vermont 5242283 05602
Contact:
Site Public Contact
802-225-5400

University of Vermont Medical Center
Burlington 5234372, Vermont 5242283 05401
Contact:
Site Public Contact
802-656-4101
rpo@uvm.edu

University of Vermont and State Agricultural College
Burlington 5234372, Vermont 5242283 05405
Contact:
Site Public Contact
802-656-8990
rpo@uvm.edu

More Details

NCT ID
NCT04333537
Status
Recruiting
Sponsor
NRG Oncology

Detailed Description

PRIMARY OBJECTIVES: I. To determine if patient-reported neck and shoulder function and related quality of life (QOL) at 6 months after surgery using the Neck Dissection Impairment Index (NDII) is superior with sentinel lymph node (SLN) biopsy compared to elective neck dissection (END) for treatment of early-stage oral cavity squamous cell carcinoma (OCSCC) (cT1-2N0). (Phase II) II. To determine if disease-free survival (DFS) is non-inferior with SLN biopsy compared to END for treatment of early-stage OCSCC (cT1-2N0). (Phase III) III. To determine if patient-reported neck and shoulder function and related QOL at 6 months after surgery using NDII is superior with SLN biopsy compared to END for treatment of early-stage OCSCC (cT1-2N0). (Phase III) SECONDARY OBJECTIVES: I. To compare patterns of failure (local-regional relapse and distant metastasis) between surgical arms. II. To measure and compare overall survival (OS) between surgical arms. III. To measure and compare the toxicity of the two surgical arms. IV. To measure longitudinal patient-reported neck and shoulder function and related QOL between surgical arms using the following instruments: IVa. Neck Dissection Impairment Index (NDII); IVb. Abbreviated Disabilities of the Arm, Shoulder and Hand (QuickDASH); IVc. Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N). V. To assess the length of hospitalization, post-operative drain placement, and operative morbidity between arms. VI. To estimate the negative predictive rate of fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) for N0 neck in patients with T1 and T1-2 oral cavity squamous cell cancer (OCSCC) patients in the END arm. VII. To assess nodal metastases rates between arms. VIII. To assess the pathologic false omission rate (FOR) in the SLN biopsy arm. IX. To determine if patient-reported neck and shoulder function using the NDII and related QOL at 6 months after surgery with SLN biopsy is superior to the END in low-risk patients. X. To compare the diagnostic performance of planar only versus (vs.) single photon emission computed tomography (SPECT)/CT plus planar for SLN mapping (phase II only). EXPLORATORY OBJECTIVES: I. To compare changes in patient-reported outcomes (European Quality of Life Five Dimension Five Level Scale Questionnaire [EQ-5D-5L]) between surgical arms. II. To collect biospecimens for future translational science studies. III. To assess the DFS between arms in low-risk patients. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients 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: Patients undergo standard END. Patients also undergo FDG PET/CT, CT, and/or chest x-ray at screening and during follow up. After completion of study treatment, patients are followed up 3 weeks after surgery, every 3 months for year 1, every 4 months for year 2, every 6 months for year 3, then yearly thereafter.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.