Offering a Comparison of Two Surgeries for Early-Stage Mouth Cancer Treatment
NCT04333537 · RecruitingThis clinical trial looks at two different surgeries for treating early-stage oral cavity cancer. One method is called sentinel lymph node biopsy, which removes fewer lymph nodes using a special imaging agent to find the most likely nodes to have cancer. The other method is called standard neck dissection, which removes more lymph nodes. The goal is to see if the sentinel lymph node biopsy helps patients with their neck and shoulder function and quality of life after surgery.
Locations and contact
This trial is running at 107 locations in 2 countries. 88 of them are currently recruiting.
United States106 locations · 87 recruiting
- Avera Cancer InstituteSioux Falls, South DakotaRecruiting
- Banner MD Anderson Cancer CenterGilbert, ArizonaRecruiting
- Banner University Medical Center - TucsonTucson, ArizonaRecruiting
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterHouston, TexasRecruiting
- Carlisle Regional Cancer CenterCarlisle, PennsylvaniaRecruiting
- Central Vermont Medical Center/National Life Cancer TreatmentBerlin Corners, VermontRecruiting
- Clackamas Radiation Oncology CenterClackamas, OregonRecruiting
- Cleveland Clinic FoundationCleveland, OhioRecruiting
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterLebanon, New HampshireRecruiting
- Drexel Town Square Health CenterOak Creek, WisconsinRecruiting
- Emory University Hospital MidtownAtlanta, GeorgiaRecruiting
- Emory University Hospital/Winship Cancer InstituteAtlanta, GeorgiaRecruiting
- Froedtert and MCW Moorland Reserve Health CenterNew Berlin, WisconsinRecruiting
- Froedtert Menomonee Falls HospitalMenomonee Falls, WisconsinRecruiting
- Froedtert West Bend Hospital/Kraemer Cancer CenterWest Bend, WisconsinRecruiting
- Geisinger Medical CenterDanville, PennsylvaniaRecruiting
- Heartland Oncology and Hematology LLPCouncil Bluffs, IowaRecruiting
- Henry Ford HospitalDetroit, MichiganRecruiting
- Henry Ford Medical Center-ColumbusNovi, MichiganRecruiting
- Henry Ford West Bloomfield HospitalWest Bloomfield, MichiganRecruiting
- Laura and Isaac Perlmutter Cancer Center at NYU LangoneNew York, New YorkRecruiting
- Mayo Clinic Hospital in ArizonaPhoenix, ArizonaRecruiting
- Mayo Clinic in RochesterRochester, MinnesotaRecruiting
- MD Anderson in Sugar LandSugar Land, TexasRecruiting
- MD Anderson in The WoodlandsConroe, TexasRecruiting
- MD Anderson West HoustonHouston, TexasRecruiting
- Medical College of WisconsinMilwaukee, WisconsinRecruiting
- Medical University of South CarolinaCharleston, South CarolinaRecruiting
- Memorial Sloan Kettering Basking RidgeBasking Ridge, New JerseyRecruiting
- Memorial Sloan Kettering BergenMontvale, New JerseyRecruiting
- Memorial Sloan Kettering Cancer CenterNew York, New YorkRecruiting
- Memorial Sloan Kettering CommackCommack, New YorkRecruiting
- Memorial Sloan Kettering MonmouthMiddletown, New JerseyRecruiting
- Memorial Sloan Kettering NassauUniondale, New YorkRecruiting
- Memorial Sloan Kettering WestchesterHarrison, New YorkRecruiting
- Methodist HospitalMemphis, TennesseeRecruiting
- Methodist Jennie Edmundson HospitalCouncil Bluffs, IowaRecruiting
- Michael E DeBakey VA Medical CenterHouston, TexasRecruiting
- Nebraska Cancer Specialists/Oncology Hematology West PC - MECCOmaha, NebraskaRecruiting
- Nebraska Methodist HospitalOmaha, NebraskaRecruiting
- Northwestern UniversityChicago, IllinoisRecruiting
- NYU Langone Hospital - Long IslandMineola, New YorkRecruiting
- Ohio State University Comprehensive Cancer CenterColumbus, OhioRecruiting
- Penn State Milton S Hershey Medical CenterHershey, PennsylvaniaRecruiting
- Providence Portland Medical CenterPortland, OregonRecruiting
- Providence Saint Vincent Medical CenterPortland, OregonRecruiting
- Roswell Park Cancer InstituteBuffalo, New YorkRecruiting
- Rush MD Anderson Cancer CenterChicago, IllinoisRecruiting
- Rutgers Cancer Institute of New JerseyNew Brunswick, New JerseyRecruiting
- Saint Barnabas Medical CenterLivingston, New JerseyRecruiting
- Smilow Cancer Hospital Care Center-TrumbullTrumbull, ConnecticutRecruiting
- SSM Health Saint Louis University HospitalSt Louis, MissouriRecruiting
- Stanford Cancer Center South BaySan Jose, CaliforniaRecruiting
- Stanford Cancer Institute Palo AltoPalo Alto, CaliforniaRecruiting
- Thomas Jefferson University HospitalPhiladelphia, PennsylvaniaRecruiting
- UC San Diego Medical Center - HillcrestSan Diego, CaliforniaRecruiting
- UC San Diego Moores Cancer CenterLa Jolla, CaliforniaRecruiting
- UCSF Medical Center-Mission BaySan Francisco, CaliforniaRecruiting
- UM Sylvester Comprehensive Cancer Center at Coral GablesCoral Gables, FloridaRecruiting
- UM Sylvester Comprehensive Cancer Center at Deerfield BeachDeerfield Beach, FloridaRecruiting
- UNC Lineberger Comprehensive Cancer CenterChapel Hill, North CarolinaRecruiting
- University of Arizona Cancer Center-North CampusTucson, ArizonaRecruiting
- University of Arkansas for Medical SciencesLittle Rock, ArkansasRecruiting
- University of Iowa/Holden Comprehensive Cancer CenterIowa City, IowaRecruiting
- University of Kansas Cancer CenterKansas City, KansasRecruiting
- University of Kansas Hospital-Westwood Cancer CenterWestwood, KansasRecruiting
- University of Kentucky/Markey Cancer CenterLexington, KentuckyRecruiting
- University of Miami Miller School of Medicine-Sylvester Cancer CenterMiami, FloridaRecruiting
- University of Michigan Rogel Cancer CenterAnn Arbor, MichiganRecruiting
- University of Oklahoma Health Sciences CenterOklahoma City, OklahomaRecruiting
- University of Pittsburgh Cancer Institute (UPCI)Pittsburgh, PennsylvaniaRecruiting
- University of Tennessee Health Science CenterMemphis, TennesseeRecruiting
- University of Vermont and State Agricultural CollegeBurlington, VermontRecruiting
- University of Vermont Medical CenterBurlington, VermontRecruiting
- UPMC Cancer Center at UPMC HorizonFarrell, PennsylvaniaRecruiting
- UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer PavilionMechanicsburg, PennsylvaniaRecruiting
- UPMC Hillman Cancer Center ErieErie, PennsylvaniaRecruiting
- UPMC MemorialYork, PennsylvaniaRecruiting
- UPMC Pinnacle Cancer Center/Community Osteopathic CampusHarrisburg, PennsylvaniaRecruiting
- UPMC-Magee Womens HospitalPittsburgh, PennsylvaniaRecruiting
- UPMC-Shadyside HospitalPittsburgh, PennsylvaniaRecruiting
- UT MD Anderson - League CityLeague City, TexasRecruiting
- UT MD Anderson Cancer CenterHouston, TexasRecruiting
- Vanderbilt University/Ingram Cancer CenterNashville, TennesseeRecruiting
- Wayne State University/Karmanos Cancer InstituteDetroit, MichiganRecruiting
- Weisberg Cancer Treatment CenterFarmington Hills, MichiganRecruiting
- Yale UniversityNew Haven, ConnecticutRecruiting
- Boston Medical CenterBoston, MassachusettsSuspended
- City of Hope Comprehensive Cancer CenterDuarte, CaliforniaActive Not Recruiting
- Fox Chase Cancer CenterPhiladelphia, PennsylvaniaActive Not Recruiting
- Lenox Hill HospitalNew York, New YorkActive Not Recruiting
- Long Island Jewish Medical CenterNew Hyde Park, New YorkActive Not Recruiting
- LSU Health Sciences Center at ShreveportShreveport, LouisianaSuspended
- Manhattan Eye Ear and Throat HospitalNew York, New YorkActive Not Recruiting
- Northwell Health/Center for Advanced MedicineLake Success, New YorkActive Not Recruiting
- Oncology Associates PCOmaha, NebraskaSuspended
- Providence Newberg Medical CenterNewberg, OregonSuspended
- Sanford Broadway Medical CenterFargo, North DakotaSuspended
- Sanford Cancer Center Oncology ClinicSioux Falls, South DakotaSuspended
- Sanford Roger Maris Cancer CenterFargo, North DakotaSuspended
- Sanford USD Medical Center - Sioux FallsSioux Falls, South DakotaSuspended
- Southern Illinois University School of MedicineSpringfield, IllinoisSuspended
- Springfield Memorial HospitalSpringfield, IllinoisSuspended
- The James Graham Brown Cancer Center at University of LouisvilleLouisville, KentuckySuspended
- University of Alabama at Birmingham Cancer CenterBirmingham, AlabamaWithdrawn
- University of California Davis Comprehensive Cancer CenterSacramento, CaliforniaActive Not Recruiting
Canada1 location · 1 recruiting
- University Health Network-Princess Margaret HospitalToronto, OntarioRecruiting
Who can join
This trial is for adults aged 18 and older, both men and women, who have been diagnosed with early-stage squamous cell carcinoma of the oral cavity. Participants must be able to read and understand English or French. Some people may not be eligible, such as those with certain other health conditions or prior cancers. The trial team will confirm who can join.
What happens during the trial
Participants will be placed into two groups by chance. One group will have the sentinel lymph node biopsy, where they will receive an imaging agent and undergo imaging before having the biopsy. The other group will have the standard neck dissection. Everyone will also have imaging tests like FDG PET/CT and chest x-rays during the study.
The trial team
The trial is sponsored by NRG Oncology, with collaboration from the National Cancer Institute. Dr. Stephen Y Lai is the principal investigator leading the study.
Important dates
The trial started on September 23, 2020, and is expected to finish on April 27, 2031. It is currently enrolling new participants.
Additional information
The trial's ID number is NCT04333537. It is a Phase 2/3 trial, meaning it is looking at how well the treatment works and how safe it is. About 686 people are expected to take part, and this trial is not using any FDA-regulated drugs or devices.
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