AzTrials
AzTrials

Buccal Mucosa Squamous Cell CarcinomaPhase 2/3NCT04333537

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

A Phase 2/3 study testing Chest Radiography, Computed Tomography and Fludeoxyglucose F-18 in people with Buccal Mucosa Squamous Cell Carcinoma and Floor of Mouth Squamous Cell Carcinoma, run by NRG Oncology at 107 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Chest Radiography, Computed Tomography and Fludeoxyglucose F-18
Could I receive a placebo?
No, everyone receives an active treatment
How many people
686 participants
Where
107 sitesin 2 countries
Study dates
23 Sep 2020to 27 Apr 2036
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 20Show fewer
  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

107 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

107 sites in 2 countries

United States106 sites, 87 recruiting

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

    Site Public Contact, 800-865-1125, CancerAnswerLine@med.umich.edu

    Marisa R. Buchakjian

    Recruiting

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

    Site Public Contact, 888-946-7447

    Jennifer Gross

    Recruiting

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

    Site Public Contact, 404-778-1868

    Jennifer Gross

    Recruiting

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

    Site Public Contact, 212-639-7592

    Jennifer R. Cracchiolo

    Recruiting

  • Central Vermont Medical Center/National Life Cancer Treatment

    Berlin Corners, Vermont, 05602

    Site Public Contact, 802-225-5400

    Mirabelle Sajisevi

    Recruiting

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

    Withdrawn

  • Boston Medical Center

    Boston, Massachusetts, 02118

    Suspended

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Site Public Contact, 800-767-9355, askroswell@roswellpark.org

    Ryan P. McSpadden

    Recruiting

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

    Site Public Contact, 802-656-4101, rpo@uvm.edu

    Mirabelle Sajisevi

    Recruiting

  • University of Vermont and State Agricultural College

    Burlington, Vermont, 05405

    Site Public Contact, 802-656-8990, rpo@uvm.edu

    Mirabelle Sajisevi

    Recruiting

  • Carlisle Regional Cancer Center

    Carlisle, Pennsylvania, 17015

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Kevin J. Contrera

    Recruiting

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

    Site Public Contact, 877-668-0683, cancerclinicaltrials@med.unc.edu

    Trevor Hackman

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Site Public Contact, 843-792-9321, hcc-clinical-trials@musc.edu

    Evan M. Graboyes

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Site Public Contact, 312-695-1301, cancer@northwestern.edu

    Sandeep Samant

    Recruiting

  • Rush MD Anderson Cancer Center

    Chicago, Illinois, 60612

    Site Public Contact, 312-226-2371, Cancer_Studies@rush.edu

    Mihir K. Bhayani

    Recruiting

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

    Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org

    Dan S. Zuckerman

    Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

    Site Public Contact, 866-223-8100, TaussigResearch@ccf.org

    Jamie A. Ku

    Recruiting

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Site Public Contact, 800-293-5066, Jamesline@osumc.edu

    Amit Agrawal

    Recruiting

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

    Site Public Contact, 212-639-7592

    Jennifer R. Cracchiolo

    Recruiting

  • MD Anderson in The Woodlands

    Conroe, Texas, 77384

    Site Public Contact, 866-632-6789, askmdanderson@mdanderson.org

    Karen Y. Choi

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    Coral Gables, Florida, 33146

    Site Public Contact, 305-243-2647

    Francisco J. Civantos

    Recruiting

  • Heartland Oncology and Hematology LLP

    Council Bluffs, Iowa, 51503

    Site Public Contact, 712-322-4136

    Aru Panwar

    Recruiting

  • Methodist Jennie Edmundson Hospital

    Council Bluffs, Iowa, 51503

    Site Public Contact, 402-354-7939, kathryn.bartz@nmhs.org

    Aru Panwar

    Recruiting

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

    Site Public Contact, 570-271-5251, HemonCCTrials@geisinger.edu

    Nicholas Purdy

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    Deerfield Beach, Florida, 33442

    Site Public Contact, 305-243-2647

    Francisco J. Civantos

    Recruiting

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Site Public Contact, 800-527-6266, ctoadmin@karmanos.org

    John D. Cramer

    Recruiting

  • Henry Ford Hospital

    Detroit, Michigan, 48202

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Eleanor M. Walker

    Recruiting

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

    Active, not recruiting

  • UPMC Hillman Cancer Center Erie

    Erie, Pennsylvania, 16505

    Site Public Contact, 412-864-7716, ClinicalResearchServices@upmc.edu

    Kevin J. Contrera

    Recruiting

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

    Suspended

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

    Suspended

  • Weisberg Cancer Treatment Center

    Farmington Hills, Michigan, 48334

    Site Public Contact, 313-576-9790, ctoadmin@karmanos.org

    John D. Cramer

    Recruiting

  • UPMC Cancer Center at UPMC Horizon

    Farrell, Pennsylvania, 16121

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Kevin J. Contrera

    Recruiting

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

    Site Public Contact, 602-747-9738

    Thomas D. Shellenberger

    Recruiting

  • UPMC Pinnacle Cancer Center/Community Osteopathic Campus

    Harrisburg, Pennsylvania, 17109

    Site Public Contact, 717-724-6765, klitchfield@PINNACLEHEALTH.org

    Kevin J. Contrera

    Recruiting

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

    Site Public Contact, 212-639-7592

    Jennifer R. Cracchiolo

    Recruiting

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

    Site Public Contact, 717-531-3779, CTO@hmc.psu.edu

    Neerav Goyal

    Recruiting

  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

    Houston, Texas, 77030

    Site Public Contact, 713-798-1354, burton@bcm.edu

    Vlad C. Sandulache

    Recruiting

  • Michael E DeBakey VA Medical Center

    Houston, Texas, 77030

    Site Public Contact, 800-553-2278

    Vlad C. Sandulache

    Recruiting

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

    Site Public Contact, 866-632-6789, askmdanderson@mdanderson.org

    Karen Y. Choi

    Recruiting

  • MD Anderson West Houston

    Houston, Texas, 77079

    Site Public Contact, 877-632-6789, askmdanderson@mdanderson.org

    Karen Y. Choi

    Recruiting

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

    Site Public Contact, 800-237-1225

    Nitin A. Pagedar

    Recruiting

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Andres M. Bur

    Recruiting

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

    Site Public Contact, 858-822-5354, cancercto@ucsd.edu

    Theresa Guo

    Recruiting

  • Northwell Health/Center for Advanced Medicine

    Lake Success, New York, 11042

    Active, not recruiting

  • UT MD Anderson - League City

    League City, Texas, 77573

    Site Public Contact, 877-632-6789, askmdanderson@mdanderson.org

    Karen Y. Choi

    Recruiting

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    Lebanon, New Hampshire, 03756

    Site Public Contact, 800-639-6918, cancer.research.nurse@dartmouth.edu

    Joseph A. Paydarfar

    Recruiting

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

    Site Public Contact, 859-257-3379

    Mark E. Bernard

    Recruiting

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

    Site Public Contact, 501-686-8274

    Emre A. Vural

    Recruiting

  • Saint Barnabas Medical Center

    Livingston, New Jersey, 07039

    Site Public Contact, 973-322-2934, joanne.loeb@rwjbh.org

    Dylan F. Roden

    Recruiting

  • The James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40202

    Suspended

  • UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

    Mechanicsburg, Pennsylvania, 17050

    Site Public Contact, 412-389-5208, haneydl@upmc.edu

    Kevin J. Contrera

    Recruiting

  • Methodist Hospital

    Memphis, Tennessee, 38104

    Site Public Contact, 901-516-2579

    John P. Gleysteen

    Recruiting

  • University of Tennessee Health Science Center

    Memphis, Tennessee, 38163

    Site Public Contact, 901-683-0055, afletcher@westclinic.com

    John P. Gleysteen

    Recruiting

  • Froedtert Menomonee Falls Hospital

    Menomonee Falls, Wisconsin, 53051

    Site Public Contact, 262-257-5100

    Joseph Zenga

    Recruiting

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

    Miami, Florida, 33136

    Site Public Contact, 305-243-2647

    Francisco J. Civantos

    Recruiting

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

    Site Public Contact, 212-639-7592

    Jennifer R. Cracchiolo

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Site Public Contact, 414-805-3666

    Joseph Zenga

    Recruiting

  • NYU Langone Hospital - Long Island

    Mineola, New York, 11501

    Site Public Contact, 212-263-4432, cancertrials@nyulangone.org

    Umamaheswar Duvvuri

    Recruiting

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

    Site Public Contact, 212-639-7592

    Jennifer R. Cracchiolo

    Recruiting

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232

    Site Public Contact, 800-811-8480

    Michael C. Topf

    Recruiting

  • Froedtert and MCW Moorland Reserve Health Center

    New Berlin, Wisconsin, 53151

    Site Public Contact, 414-805-0505

    Joseph Zenga

    Recruiting

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

    Site Public Contact, 732-235-7356

    Dylan F. Roden

    Recruiting

  • Yale University

    New Haven, Connecticut, 06520

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Saral Mehra

    Recruiting

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040

    Active, not recruiting

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

    Site Public Contact, CancerTrials@nyulangone.org

    Umamaheswar Duvvuri

    Recruiting

  • Manhattan Eye Ear and Throat Hospital

    New York, New York, 10065

    Active, not recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Site Public Contact, 212-639-7592

    Jennifer R. Cracchiolo

    Recruiting

  • Lenox Hill Hospital

    New York, New York, 10075

    Active, not recruiting

  • Providence Newberg Medical Center

    Newberg, Oregon, 97132

    Suspended

  • Henry Ford Medical Center-Columbus

    Novi, Michigan, 48377

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Eleanor M. Walker

    Recruiting

  • Drexel Town Square Health Center

    Oak Creek, Wisconsin, 53154

    Site Public Contact, 414-805-0505

    Joseph Zenga

    Recruiting

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

    Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu

    Rusha J. Patel

    Recruiting

  • Nebraska Cancer Specialists/Oncology Hematology West PC - MECC

    Omaha, Nebraska, 68114

    Site Public Contact, 402-334-4773

    Aru Panwar

    Recruiting

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

    Site Public Contact, 402-354-5144

    Aru Panwar

    Recruiting

  • Oncology Associates PC

    Omaha, Nebraska, 68114

    Suspended

  • Stanford Cancer Institute Palo Alto

    Palo Alto, California, 94304

    Site Public Contact, 650-498-7061, ccto-office@stanford.edu

    Fred Baik

    Recruiting

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

    Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu

    David M. Cognetti

    Recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

    Active, not recruiting

  • Mayo Clinic Hospital in Arizona

    Phoenix, Arizona, 85054

    Site Public Contact, 855-776-0015

    Kyle S. Ettinger

    Recruiting

  • UPMC-Magee Womens Hospital

    Pittsburgh, Pennsylvania, 15213

    Site Public Contact, 412-647-2811

    Kevin J. Contrera

    Recruiting

  • University of Pittsburgh Cancer Institute (UPCI)

    Pittsburgh, Pennsylvania, 15232

    Site Public Contact, 412-647-8073

    Kevin J. Contrera

    Recruiting

  • UPMC-Shadyside Hospital

    Pittsburgh, Pennsylvania, 15232

    Site Public Contact, 412-621-2334

    Kevin J. Contrera

    Recruiting

  • Providence Portland Medical Center

    Portland, Oregon, 97213

    Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org

    Dan S. Zuckerman

    Recruiting

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225

    Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org

    Dan S. Zuckerman

    Recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

    Site Public Contact, 855-776-0015

    Kyle S. Ettinger

    Recruiting

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

    Active, not recruiting

  • UC San Diego Medical Center - Hillcrest

    San Diego, California, 92103

    Site Public Contact, rhabbaba@health.ucsd.edu

    Theresa Guo

    Recruiting

  • UCSF Medical Center-Mission Bay

    San Francisco, California, 94158

    Site Public Contact, 877-827-3222, cancertrials@ucsf.edu

    Jason Chan

    Recruiting

  • Stanford Cancer Center South Bay

    San Jose, California, 95124

    Site Public Contact, 650-498-7061, ccto-office@stanford.edu

    Fred Baik

    Recruiting

  • LSU Health Sciences Center at Shreveport

    Shreveport, Louisiana, 71103

    Suspended

  • Sanford Cancer Center Oncology Clinic

    Sioux Falls, South Dakota, 57104

    Suspended

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

    Site Public Contact, 605-322-3095, OncRegulatory@avera.org

    William C. Spanos

    Recruiting

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134

    Suspended

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

    Suspended

  • Springfield Memorial Hospital

    Springfield, Illinois, 62781

    Suspended

  • SSM Health Saint Louis University Hospital

    St Louis, Missouri, 63104

    Site Public Contact, 314-977-4440

    Sean Massa

    Recruiting

  • MD Anderson in Sugar Land

    Sugar Land, Texas, 77478

    Site Public Contact, 877-632-6789, askmdanderson@mdanderson.org

    Karen Y. Choi

    Recruiting

  • Smilow Cancer Hospital Care Center-Trumbull

    Trumbull, Connecticut, 06611

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Saral Mehra

    Recruiting

  • Banner University Medical Center - Tucson

    Tucson, Arizona, 85719

    Site Public Contact, UACC-IIT@uacc.arizona.edu

    Steven J. Wang

    Recruiting

  • University of Arizona Cancer Center-North Campus

    Tucson, Arizona, 85719

    Site Public Contact, UACC-IIT@uacc.arizona.edu

    Steven J. Wang

    Recruiting

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553

    Site Public Contact, 212-639-7592

    Jennifer R. Cracchiolo

    Recruiting

  • Froedtert West Bend Hospital/Kraemer Cancer Center

    West Bend, Wisconsin, 53095

    Site Public Contact, 414-805-0505

    Joseph Zenga

    Recruiting

  • Henry Ford West Bloomfield Hospital

    West Bloomfield, Michigan, 48322

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Eleanor M. Walker

    Recruiting

  • University of Kansas Hospital-Westwood Cancer Center

    Westwood, Kansas, 66205

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Andres M. Bur

    Recruiting

  • UPMC Memorial

    York, Pennsylvania, 17408

    Site Public Contact, 717-724-6760

    Kevin J. Contrera

    Recruiting

Other trials in United States

Canada1 site, 1 recruiting

  • University Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

    Site Public Contact, 416-946-4501, clinical.trials@uhn.on.ca

    John R. de Almeida

    Recruiting

Other trials in Canada

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

  1. 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:

  1. 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.

Being tested
Chest Radiography, Computed Tomography, Fludeoxyglucose F-18, Imaging Agent, Neck Dissection
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Mouth Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chest RadiographyProcedure or surgery

    Also called Chest X-ray

    Undergo chest x-ray

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo SPECT/CT scan and FDG PET/CT or CT

  • Fludeoxyglucose F-18Other

    Also called 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18

    Undergo FDG PET/CT

  • Imaging AgentDrug

    Also called Image Enhancement Agent

    Receive imaging agent via injection

  • Neck DissectionProcedure or surgery

    Undergo standard elective neck dissection

  • Planar ImagingProcedure or surgery

    Undergo planar imaging

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo FDG PET/CT

  • Questionnaire AdministrationOther

    Ancillary studies

  • Sentinel Lymph Node BiopsyProcedure or surgery

    Also called Sentinel Node Biopsy, Sentinel node biopsy alone, SLNB, SNB

    Undergo SLN biopsy

  • Single Photon Emission Computed TomographyProcedure or surgery

    Also called Medical Imaging, Single Photon Emission Computed Tomography, Single Photon Emission Tomography, Single-Photon Emission Computed, single-photon emission computed tomography

    Undergo SPECT/CT scan

Study groups in NCT04333537
Study groupRoleWhat they receive
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.
Receives: Procedure: Chest Radiography; Procedure: Computed Tomography; Other: Fludeoxyglucose F-18; Drug: Imaging Agent; Procedure: Planar Imaging; Procedure: Positron Emission Tomography; Other: Questionnaire Administration; Procedure: Sentinel Lymph Node Biopsy; Procedure: Single Photon Emission Computed Tomography
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.
Receives: Procedure: Chest Radiography; Other: Fludeoxyglucose F-18; Procedure: Neck Dissection; Procedure: Positron Emission Tomography; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Before surgery (Baseline), 3 weeks after surgery, 3, 6, 12 months after surgery

  2. Patient reported quality of life (QOL) (Phase II)

    Will be measured using 3 questionnaires over 12-15 minutes.

    Measured: Before surgery (Baseline), 3 weeks after surgery, 3, 6, 12 months after surgery

  3. 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.

    Measured: 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)

  1. Overall survival rate

    Will be estimated using the Kaplan-Meier method and between-arm differences compared using the log-rank test.

    Measured: From randomization to death due to any cause, assessed up to 11 years

  2. Loco-regional failure

    The cumulative incidence estimator will be used to estimate time to event distributions with between arm differences using cause-specific log-rank test.

    Measured: 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

  3. Distant metastasis

    The cumulative incidence estimator will be used to estimate event distributions with between arm differences tested using cause-specific log-rank test.

    Measured: 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

  4. Toxicity

    Measured by the Common Terminology Criteria for Adverse Events version 5.0. The proportion of patients with at least 1 grade 3 or higher adverse event will be compared between treatment arms.

    Measured: Time of primary endpoint analysis

  5. Patient-reported shoulder-related QOL, function impairment and disability

    Patient reported using Abbreviated Disabilities of the Arm, Shoulder, and Hand (QuickDASH) with scores of 0-100. A higher score indicates greater disability.

    Measured: Baseline, 3 weeks, 3, 6, 12 months post-surgery

  6. General quality of life

    Will be measured using the Functional Assessment of Cancer Therapy-Head and Neck to measure Functional Assessment of Cancer Therapy-Head and Neck-Trial Outcome Index scores on a scale from 0-96. A higher score indicates better quality of life.

    Measured: Baseline, 3 weeks, 3, 6, 12 months post-surgery

  7. Nodal metastasis detection rate

    Defined as the proportion of patients with pathologic positive nodes using the pathology results.

    Measured: At time of surgery

  8. Pathologic false omission rate

    Measured within the sentinel lymph node biopsy (SLN) arm only. Defined as the proportion of patients with false negative results among negative SLN patients.

    Measured: At time of surgery

  9. Length of hospital stay

    Length of hospital stay due to surgical procedure will be compared between arms using the Mann-Whitney test.

    Measured: Prior to surgery, at time of discharge from surgery

  10. Post-surgery patient-reported outcome

    Measured by NDII in low-risk oral cavity squamous cell carcinoma patients using analysis of covariance comparison model.

    Measured: At 6 months post-surgery

  11. Diagnostic performance (Phase II only)

    Descriptive statistics (minimum, maximum, mean, standard deviation, and coefficient of variation) of the number of detected SLNs will be calculated by modality and neck sublevel. The difference of the number of SLNs between single photon emission computed tomography/computed tomography plus planar and planar only will be computed and summarized by neck sublevel, reader, and overall. Pairwise absolute differences of the number of detected SLNs among readers will be computed and summarized by modality and neck sublevel.

    Measured: Up to 11 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2020
  2. Study start23 Sep 2020
  3. Primary completion27 Apr 2031 (estimated)
  4. Study completion27 Apr 2036 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
686 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04333537
Sponsor's protocol ID
NRG-HN006
Other IDs
NCI-2020-01542, NRG-HN006, NRG-HN006, U10CA180868
Status last verified
Aug 2026
First submitted
26 Mar 2020
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Chest Radiography, Computed Tomography and Fludeoxyglucose F-18 in people with Buccal Mucosa Squamous Cell Carcinoma and Floor of Mouth Squamous Cell Carcinoma, run by NRG Oncology at 107 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 107 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient-reported neck and shoulder function (Phase II/III) (time frame: Before surgery (Baseline), 3 weeks after surgery, 3, 6, 12 months after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04333537.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in