Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection for Patients With Early-Stage Oral Cavity Cancer
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
Interventions
Chest Radiography
Computed Tomography
Fludeoxyglucose F-18
Imaging Agent
Neck Dissection
Planar Imaging
Positron Emission Tomography
Questionnaire Administration
Sentinel Lymph Node Biopsy
Single Photon Emission Computed Tomography
Conditions
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