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NCT04333537PHASE2, PHASE3Recruiting

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

NRG Oncology

Start Date

9/23/2020

Completion Date

4/27/2031

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.

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

PROCEDURE

Chest Radiography

PROCEDURE

Computed Tomography

OTHER

Fludeoxyglucose F-18

DRUG

Imaging Agent

PROCEDURE

Neck Dissection

PROCEDURE

Planar Imaging

PROCEDURE

Positron Emission Tomography

OTHER

Questionnaire Administration

PROCEDURE

Sentinel Lymph Node Biopsy

PROCEDURE

Single Photon Emission Computed Tomography

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Conditions

Buccal Mucosa Squamous Cell CarcinomaFloor of Mouth Squamous Cell CarcinomaGingival Squamous Cell CarcinomaHard Palate Squamous Cell CarcinomaLip Squamous Cell CarcinomaLower Alveolar Ridge Squamous Cell CarcinomaOral Cavity Squamous Cell CarcinomaRetromolar Trigone Squamous Cell CarcinomaStage I Lip and Oral Cavity Cancer AJCC v8Stage II Lip and Oral Cavity Cancer AJCC v8Tongue Squamous Cell CarcinomaUpper Alveolar Ridge Squamous Cell Carcinoma

Locations

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

Harrison, 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 Cancer Center at UPMC Horizon

Farrell, Pennsylvania 16121

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

Michael E DeBakey VA Medical Center

Houston, Texas 77030

United States

UT MD Anderson Cancer Center

Houston, Texas 77030

United States

MD Anderson West Houston

Houston, Texas 77079

United States

UT 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