Randomized Phase II/III Trial of Sentinel Lymph Node Biopsy Versus Elective Neck Dissection for Early-Stage Oral Cavity Cancer
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.
Arms & interventions
- ProcedureChest Radiography
Undergo chest x-ray
- ProcedureComputed Tomography
Undergo SPECT/CT scan and FDG PET/CT or CT
- OtherFludeoxyglucose F-18
Undergo FDG PET/CT
- DrugImaging Agent
Receive imaging agent via injection
- ProcedureNeck Dissection
Undergo standard elective neck dissection
- ProcedurePlanar Imaging
Undergo planar imaging
- ProcedurePositron Emission Tomography
Undergo FDG PET/CT
- OtherQuestionnaire Administration
Ancillary studies
- ProcedureSentinel Lymph Node Biopsy
Undergo SLN biopsy
- ProcedureSingle Photon Emission Computed Tomography
Undergo SPECT/CT scan
Outcome measures
Primary
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.
Time frame: Before surgery (Baseline), 3 weeks after surgery, 3, 6, 12 months after surgery
Patient reported quality of life (QOL) (Phase II)
Will be measured using 3 questionnaires over 12-15 minutes.
Time frame: Before surgery (Baseline), 3 weeks after surgery, 3, 6, 12 months after surgery
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.
Time frame: From randomization to local/regional recurrence, distant metastasis, or death due to any cause, whichever comes first, assessed up to 11 years
Secondary
Overall survival rate
Time frame: From randomization to death due to any cause, assessed up to 11 years
Loco-regional failure
Time frame: 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
Distant metastasis
Time frame: 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
Toxicity
Time frame: Time of primary endpoint analysis
Patient-reported shoulder-related QOL, function impairment and disability
Time frame: Baseline, 3 weeks, 3, 6, 12 months post-surgery
General quality of life
Time frame: Baseline, 3 weeks, 3, 6, 12 months post-surgery
Nodal metastasis detection rate
Time frame: At time of surgery
Pathologic false omission rate
Time frame: At time of surgery
Length of hospital stay
Time frame: Prior to surgery, at time of discharge from surgery
Post-surgery patient-reported outcome
Time frame: At 6 months post-surgery
Diagnostic performance (Phase II only)
Time frame: Up to 11 years
Eligibility criteria
Study locations (105)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, 85054
Banner University Medical Center - Tucson
Tucson, Arizona, 85719
University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
UC San Diego Medical Center - Hillcrest
San Diego, California, 92103
UCSF Medical Center-Mission Bay
San Francisco, California, 94158
Stanford Cancer Center South Bay
San Jose, California, 95124
Yale University
New Haven, Connecticut, 06520
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, 06611
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, 33146
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, 33442
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Northwestern University
Chicago, Illinois, 60611
Rush MD Anderson Cancer Center
Chicago, Illinois, 60612
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Springfield Memorial Hospital
Springfield, Illinois, 62781
Heartland Oncology and Hematology LLP
Council Bluffs, Iowa, 51503
Methodist Jennie Edmundson Hospital
Council Bluffs, Iowa, 51503
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
University of Kansas Cancer Center
Kansas City, Kansas, 66160
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, 40202
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana, 71103
Boston Medical Center
Boston, Massachusetts, 02118
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201
Henry Ford Hospital
Detroit, Michigan, 48202
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334
Henry Ford Medical Center-Columbus
Novi, Michigan, 48377
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
SSM Health Saint Louis University Hospital
St Louis, Missouri, 63104
Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
Omaha, Nebraska, 68114
Nebraska Methodist Hospital
Omaha, Nebraska, 68114
Oncology Associates PC
Omaha, Nebraska, 68114
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Saint Barnabas Medical Center
Livingston, New Jersey, 07039
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Roswell Park Cancer Institute
Buffalo, New York, 14263
Memorial Sloan Kettering Commack
Commack, New York, 11725
Memorial Sloan Kettering Westchester
East White Plains, New York, 10604
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042
NYU Langone Hospital - Long Island
Mineola, New York, 11501
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016
Manhattan Eye Ear and Throat Hospital
New York, New York, 10065
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Lenox Hill Hospital
New York, New York, 10075
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015
Providence Newberg Medical Center
Newberg, Oregon, 97132
Providence Portland Medical Center
Portland, Oregon, 97213
Providence Saint Vincent Medical Center
Portland, Oregon, 97225
Carlisle Regional Cancer Center
Carlisle, Pennsylvania, 17015
Geisinger Medical Center
Danville, Pennsylvania, 17822
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, 16505
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania, 17109
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania, 17050
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, 15232
UPMC Memorial
York, Pennsylvania, 17408
Medical University of South Carolina
Charleston, South Carolina, 29425
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
Methodist Hospital
Memphis, Tennessee, 38104
University of Tennessee Health Science Center
Memphis, Tennessee, 38163
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
MD Anderson in The Woodlands
Conroe, Texas, 77384
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030
M D Anderson Cancer Center
Houston, Texas, 77030
Michael E DeBakey VA Medical Center
Houston, Texas, 77030
MD Anderson West Houston
Houston, Texas, 77079
MD Anderson League City
League City, Texas, 77573
MD Anderson in Sugar Land
Sugar Land, Texas, 77478
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, 05602
University of Vermont Medical Center
Burlington, Vermont, 05401
University of Vermont and State Agricultural College
Burlington, Vermont, 05405
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, 53051
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Froedtert and MCW Moorland Reserve Health Center
New Berlin, Wisconsin, 53151
Drexel Town Square Health Center
Oak Creek, Wisconsin, 53154
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin, 53095