Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection for Patients With Early-Stage Oral Cavity Cancer
Buccal Mucosa Squamous Cell Carcinoma, Floor of Mouth Squamous Cell Carcinoma, Gingival Squamous Cell Carcinoma
About this trial
This is an interventional treatment trial for Buccal Mucosa Squamous Cell Carcinoma
Eligibility Criteria
Inclusion Criteria:
- PRIOR TO STEP 1 REGISTRATION INCLUSION:
- Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma 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 for 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
- 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 are eligible to participate as the mandatory patient reported NDII tool is only available in this language
- 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 squamous cell carcinoma (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 a different cancer is allowable
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- Patient with 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-guided (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 (sarcoidosis or untreated mycobacterial infection)
- Actively receiving systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte or immunomodulatory therapy
- Currently participating in another investigational therapeutic trial
Sites / Locations
- Banner University Medical Center - TucsonRecruiting
- University of Arizona Cancer Center-North CampusRecruiting
- University of Arkansas for Medical SciencesRecruiting
- City of Hope Comprehensive Cancer CenterRecruiting
- UC San Diego Moores Cancer CenterRecruiting
- Stanford Cancer Institute Palo AltoRecruiting
- University of California Davis Comprehensive Cancer Center
- Yale UniversityRecruiting
- Smilow Cancer Hospital Care Center-TrumbullRecruiting
- UM Sylvester Comprehensive Cancer Center at Coral GablesRecruiting
- UM Sylvester Comprehensive Cancer Center at Deerfield BeachRecruiting
- University of Miami Miller School of Medicine-Sylvester Cancer CenterRecruiting
- Emory University Hospital MidtownRecruiting
- Emory University Hospital/Winship Cancer InstituteRecruiting
- Northwestern UniversityRecruiting
- Rush University Medical CenterRecruiting
- Southern Illinois University School of Medicine
- Memorial Medical Center
- University of Iowa/Holden Comprehensive Cancer CenterRecruiting
- University of Kansas Cancer CenterRecruiting
- University of Kansas Hospital-Westwood Cancer CenterRecruiting
- University of Kentucky/Markey Cancer Center
- The James Graham Brown Cancer Center at University of LouisvilleRecruiting
- LSU Health Sciences Center at ShreveportRecruiting
- Boston Medical Center
- University of Michigan Comprehensive Cancer CenterRecruiting
- Wayne State University/Karmanos Cancer InstituteRecruiting
- Henry Ford HospitalRecruiting
- Weisberg Cancer Treatment CenterRecruiting
- Nebraska Cancer Specialists/Oncology Hematology West PC - MECCRecruiting
- Nebraska Methodist HospitalRecruiting
- Oncology Associates PCRecruiting
- Memorial Sloan Kettering Basking RidgeRecruiting
- Saint Barnabas Medical CenterRecruiting
- Memorial Sloan Kettering MonmouthRecruiting
- Memorial Sloan Kettering BergenRecruiting
- Rutgers Cancer Institute of New JerseyRecruiting
- Roswell Park Cancer InstituteRecruiting
- Memorial Sloan Kettering CommackRecruiting
- Memorial Sloan Kettering WestchesterRecruiting
- Northwell Health/Center for Advanced Medicine
- Long Island Jewish Medical Center
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
- Lenox Hill HospitalRecruiting
- Manhattan Eye Ear and Throat HospitalRecruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- Memorial Sloan Kettering NassauRecruiting
- Sanford Broadway Medical CenterRecruiting
- Sanford Roger Maris Cancer CenterRecruiting
- Cleveland Clinic FoundationRecruiting
- Ohio State University Comprehensive Cancer CenterRecruiting
- University of Oklahoma Health Sciences CenterRecruiting
- Clackamas Radiation Oncology CenterRecruiting
- Providence Newberg Medical Center
- Providence Portland Medical CenterRecruiting
- Providence Saint Vincent Medical CenterRecruiting
- Geisinger Medical CenterRecruiting
- Penn State Milton S Hershey Medical CenterRecruiting
- Thomas Jefferson University HospitalRecruiting
- Fox Chase Cancer Center
- University of Pittsburgh Cancer Institute (UPCI)Recruiting
- UPMC-Shadyside HospitalRecruiting
- Sanford Cancer Center Oncology ClinicRecruiting
- Avera Cancer InstituteRecruiting
- Sanford USD Medical Center - Sioux FallsRecruiting
- Methodist HospitalRecruiting
- University of Tennessee Health Science CenterRecruiting
- Vanderbilt University/Ingram Cancer CenterRecruiting
- MD Anderson in The WoodlandsRecruiting
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterRecruiting
- M D Anderson Cancer CenterRecruiting
- Michael E DeBakey VA Medical CenterRecruiting
- MD Anderson West HoustonRecruiting
- MD Anderson League CityRecruiting
- MD Anderson in Sugar LandRecruiting
- Central Vermont Medical Center/National Life Cancer TreatmentRecruiting
- University of Vermont Medical CenterRecruiting
- University of Vermont and State Agricultural CollegeRecruiting
- University Health Network-Princess Margaret HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Sentinel Lymph Node (SLN) Biopsy
Elective Neck Dissection (END)
Patients receive an imaging agent via injection and undergo planar imaging and SPECT/CT over 1-2 hours. Patients then undergo SLN biopsy.
Patients undergo standard END.