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 Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • PRIOR TO STEP 1 REGISTRATION INCLUSION: - Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma 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; CT portion of the PET/CT must be of diagnostic quality - Chest imaging with either a chest x-ray, CT chest scan (with or without contrast) or PET/CT (with or without contrast) within 42 days prior to registration - 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 - 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 English-speaking patients (able to read and understand English) are eligible to participate as the mandatory patient reported NDII tool is only available in this language - 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. However, if the FDG PET/CT is not of diagnostic quality, then FDG PET/CT will have to be repeated prior to Step 2 registration - PET/CT node negative patients, determined by central read, will proceed to randomization. - PET/CT 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)

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 squamous cell carcinoma (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 a different cancer is allowable - Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields - Patient with 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-guided (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 (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
Sentinel Lymph Node (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.
  • Procedure: Computed Tomography (CT)
    Undergo SPECT/CT scan
    Other names:
    • CAT
    • CAT scan
    • Computed Tomography
    • computerized axial tomography
    • Computerized Tomography
    • CT
    • CT scan
    • tomography
  • Drug: Imaging Agent
    Receive imaging agent via injection
    Other names:
    • Image Enhancement Agent
  • Procedure: Planar Imaging
    Undergo planar imaging
  • 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 tomography
    • SPECT
    • SPECT imaging
    • SPECT SCAN
    • SPET
    • tomography, emission computed, single photon
    • Tomography, Emission-Computed, Single-Photon
Active Comparator
Elective Neck Dissection (END)
Patients undergo standard END.
  • Procedure: Computed Tomography (CT)
    Undergo SPECT/CT scan
    Other names:
    • CAT
    • CAT scan
    • Computed Tomography
    • computerized axial tomography
    • Computerized Tomography
    • CT
    • CT scan
    • tomography
  • Procedure: Neck Dissection
    Undergo standard elective neck dissection

Recruiting Locations

Banner University Medical Center - Tucson
Tucson, Arizona 85719
Contact:
Site Public Contact
aselegue@email.arizona.edu

University of Arizona Cancer Center-North Campus
Tucson, Arizona 85719
Contact:
Site Public Contact
800-327-2873

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

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

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

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

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

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

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

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

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

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

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

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

Memorial Medical Center
Springfield, Illinois 62781
Contact:
Site Public Contact
217-788-3528

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

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

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

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

University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan 48109
Contact:
Site Public Contact
800-865-1125

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

University of Vermont and State Agricultural College
Burlington, Vermont 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/computed tomography (PET/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 and related QOL at 6 months after surgery using the NDII is superior with the SLN biopsy compared to the END in low-risk patients. 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 single photo emission computed tomography/computed tomography (SPECT/CT) over 1-2 hours. Patients then undergo SLN biopsy. GROUP II: Patients undergo standard END. 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.