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

Who is this study for? Adult patients with Head and Neck Squamous Cell Carcinoma
Status: Recruiting
Location: See all (100) locations...
Intervention Type: Procedure, Drug, Other
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Alabama
University of Alabama at Birmingham Cancer Center
ACTIVE_NOT_RECRUITING
Birmingham
Arkansas
University of Arkansas for Medical Sciences
RECRUITING
Little Rock
Arizona
Banner MD Anderson Cancer Center
RECRUITING
Gilbert
Mayo Clinic Hospital in Arizona
RECRUITING
Phoenix
Banner University Medical Center - Tucson
RECRUITING
Tucson
University of Arizona Cancer Center-North Campus
RECRUITING
Tucson
California
City of Hope Comprehensive Cancer Center
ACTIVE_NOT_RECRUITING
Duarte
UC San Diego Moores Cancer Center
RECRUITING
La Jolla
Stanford Cancer Institute Palo Alto
RECRUITING
Palo Alto
University of California Davis Comprehensive Cancer Center
RECRUITING
Sacramento
UC San Diego Medical Center - Hillcrest
RECRUITING
San Diego
UCSF Medical Center-Mission Bay
RECRUITING
San Francisco
Stanford Cancer Center South Bay
RECRUITING
San Jose
Connecticut
Yale University
RECRUITING
New Haven
Smilow Cancer Hospital Care Center-Trumbull
RECRUITING
Trumbull
Florida
UM Sylvester Comprehensive Cancer Center at Coral Gables
RECRUITING
Coral Gables
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
RECRUITING
Deerfield Beach
University of Miami Miller School of Medicine-Sylvester Cancer Center
RECRUITING
Miami
Georgia
Emory University Hospital Midtown
RECRUITING
Atlanta
Emory University Hospital/Winship Cancer Institute
RECRUITING
Atlanta
Iowa
Heartland Oncology and Hematology LLP
RECRUITING
Council Bluffs
Methodist Jennie Edmundson Hospital
RECRUITING
Council Bluffs
University of Iowa/Holden Comprehensive Cancer Center
RECRUITING
Iowa City
Illinois
Northwestern University
RECRUITING
Chicago
Rush MD Anderson Cancer Center
RECRUITING
Chicago
Southern Illinois University School of Medicine
SUSPENDED
Springfield
Springfield Memorial Hospital
SUSPENDED
Springfield
Kansas
University of Kansas Cancer Center
RECRUITING
Kansas City
University of Kansas Hospital-Westwood Cancer Center
RECRUITING
Westwood
Kentucky
University of Kentucky/Markey Cancer Center
RECRUITING
Lexington
The James Graham Brown Cancer Center at University of Louisville
SUSPENDED
Louisville
Louisiana
LSU Health Sciences Center at Shreveport
SUSPENDED
Shreveport
Massachusetts
Boston Medical Center
SUSPENDED
Boston
Michigan
University of Michigan Comprehensive Cancer Center
RECRUITING
Ann Arbor
Henry Ford Hospital
RECRUITING
Detroit
Wayne State University/Karmanos Cancer Institute
RECRUITING
Detroit
Weisberg Cancer Treatment Center
RECRUITING
Farmington Hills
Henry Ford Medical Center-Columbus
RECRUITING
Novi
Henry Ford West Bloomfield Hospital
RECRUITING
West Bloomfield
Minnesota
Mayo Clinic in Rochester
RECRUITING
Rochester
Missouri
SSM Health Saint Louis University Hospital
RECRUITING
St Louis
North Carolina
UNC Lineberger Comprehensive Cancer Center
RECRUITING
Chapel Hill
North Dakota
Sanford Broadway Medical Center
SUSPENDED
Fargo
Sanford Roger Maris Cancer Center
SUSPENDED
Fargo
Nebraska
Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
RECRUITING
Omaha
Nebraska Methodist Hospital
RECRUITING
Omaha
Oncology Associates PC
SUSPENDED
Omaha
New Hampshire
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
RECRUITING
Lebanon
New Jersey
Memorial Sloan Kettering Basking Ridge
RECRUITING
Basking Ridge
Saint Barnabas Medical Center
RECRUITING
Livingston
Memorial Sloan Kettering Monmouth
RECRUITING
Middletown
Memorial Sloan Kettering Bergen
RECRUITING
Montvale
Rutgers Cancer Institute of New Jersey
RECRUITING
New Brunswick
New York
Roswell Park Cancer Institute
RECRUITING
Buffalo
Memorial Sloan Kettering Commack
RECRUITING
Commack
Memorial Sloan Kettering Westchester
RECRUITING
Harrison
Northwell Health/Center for Advanced Medicine
ACTIVE_NOT_RECRUITING
Lake Success
NYU Langone Hospital - Long Island
RECRUITING
Mineola
Long Island Jewish Medical Center
ACTIVE_NOT_RECRUITING
New Hyde Park
Laura and Isaac Perlmutter Cancer Center at NYU Langone
RECRUITING
New York
Lenox Hill Hospital
ACTIVE_NOT_RECRUITING
New York
Manhattan Eye Ear and Throat Hospital
ACTIVE_NOT_RECRUITING
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Memorial Sloan Kettering Nassau
RECRUITING
Uniondale
Ohio
Cleveland Clinic Foundation
RECRUITING
Cleveland
Ohio State University Comprehensive Cancer Center
RECRUITING
Columbus
Oklahoma
University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Oregon
Clackamas Radiation Oncology Center
RECRUITING
Clackamas
Providence Newberg Medical Center
SUSPENDED
Newberg
Providence Portland Medical Center
RECRUITING
Portland
Providence Saint Vincent Medical Center
RECRUITING
Portland
Pennsylvania
Carlisle Regional Cancer Center
RECRUITING
Carlisle
Geisinger Medical Center
RECRUITING
Danville
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
RECRUITING
Harrisburg
Penn State Milton S Hershey Medical Center
SUSPENDED
Hershey
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
RECRUITING
Mechanicsburg
Fox Chase Cancer Center
ACTIVE_NOT_RECRUITING
Philadelphia
Thomas Jefferson University Hospital
RECRUITING
Philadelphia
University of Pittsburgh Cancer Institute (UPCI)
RECRUITING
Pittsburgh
UPMC-Magee Womens Hospital
RECRUITING
Pittsburgh
UPMC-Shadyside Hospital
RECRUITING
Pittsburgh
UPMC Memorial
RECRUITING
York
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
South Dakota
Avera Cancer Institute
RECRUITING
Sioux Falls
Sanford Cancer Center Oncology Clinic
RECRUITING
Sioux Falls
Sanford USD Medical Center - Sioux Falls
RECRUITING
Sioux Falls
Tennessee
Methodist Hospital
RECRUITING
Memphis
University of Tennessee Health Science Center
RECRUITING
Memphis
Vanderbilt University/Ingram Cancer Center
RECRUITING
Nashville
Texas
MD Anderson in The Woodlands
RECRUITING
Conroe
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
RECRUITING
Houston
M D Anderson Cancer Center
RECRUITING
Houston
MD Anderson West Houston
RECRUITING
Houston
Michael E DeBakey VA Medical Center
RECRUITING
Houston
MD Anderson League City
RECRUITING
League City
MD Anderson in Sugar Land
RECRUITING
Sugar Land
Vermont
Central Vermont Medical Center/National Life Cancer Treatment
RECRUITING
Berlin Corners
University of Vermont and State Agricultural College
RECRUITING
Burlington
University of Vermont Medical Center
RECRUITING
Burlington
Other Locations
Canada
University Health Network-Princess Margaret Hospital
RECRUITING
Toronto
Time Frame
Start Date: 2020-09-23
Estimated Completion Date: 2031-04-27
Participants
Target number of participants: 686
Treatments
Experimental: Group I (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. Patients also undergo FDG PET/CT, CT, and/or chest x-ray at screening and during follow up.
Active_comparator: Group II (END)
Patients undergo standard END. Patients also undergo FDG PET/CT, CT, and/or chest x-ray at screening and during follow up.
Sponsors
Leads: NRG Oncology
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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