Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection for Patients With Early-Stage Oral Cavity Cancer

Recruiting now · Phase 2/Phase 3

Conditions studied: Buccal Mucosa Squamous Cell Carcinoma, Floor of Mouth Squamous Cell Carcinoma, Gingival Squamous Cell Carcinoma, Hard Palate Squamous Cell Carcinoma, Lip Squamous Cell Carcinoma, Lower Alveolar Ridge Squamous Cell Carcinoma, Oral Cavity Squamous Cell Carcinoma, Retromolar Trigone Squamous Cell Carcinoma, Stage I Lip and Oral Cavity Cancer AJCC v8, Stage II Lip and Oral Cavity Cancer AJCC v8, Tongue Squamous Cell Carcinoma, Upper Alveolar Ridge Squamous Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT04333537

Run by

NRG Oncology

People needed

686

Starts

2020-09-23

Expected to finish

2031-04-27

Last updated by the study team

2026-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 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 different cancer(s) is allowable
• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
• 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 (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 (e.g., sarcoidosis or untreated mycobacterial infection)
• Actively receiving systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte or immunomodulatory therapy
• Currently participating in another investigational therapeutic trial

Where it is running

• University of Iowa/Holden Comprehensive Cancer Center — Iowa City, Iowa, United States (enrolling)
• University of Kansas Hospital-Westwood Cancer Center — Westwood, Kansas, United States (enrolling)
• Banner University Medical Center - Tucson — Tucson, Arizona, United States (enrolling)
• Methodist Jennie Edmundson Hospital — Council Bluffs, Iowa, United States (enrolling)
• University of Kansas Cancer Center — Kansas City, Kansas, United States (enrolling)
• Mayo Clinic Hospital in Arizona — Phoenix, Arizona, United States (enrolling)
• UC San Diego Moores Cancer Center — La Jolla, California, United States (enrolling)
• Stanford Cancer Institute Palo Alto — Palo Alto, California, United States (enrolling)
• University of Arizona Cancer Center-North Campus — Tucson, Arizona, United States (enrolling)
• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States (enrolling)
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (enrolling)
• Stanford Cancer Center South Bay — San Jose, California, United States (enrolling)
• Yale University — New Haven, Connecticut, United States (enrolling)
• Smilow Cancer Hospital Care Center-Trumbull — Trumbull, Connecticut, United States (enrolling)
• UM Sylvester Comprehensive Cancer Center at Coral Gables — Coral Gables, Florida, United States (enrolling)
• UM Sylvester Comprehensive Cancer Center at Deerfield Beach — Deerfield Beach, Florida, United States (enrolling)
• University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida, United States (enrolling)
• Emory University Hospital Midtown — Atlanta, Georgia, United States (enrolling)
• Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States (enrolling)
• Northwestern University — Chicago, Illinois, United States (enrolling)
• Rush MD Anderson Cancer Center — Chicago, Illinois, United States (enrolling)
• UC San Diego Medical Center - Hillcrest — San Diego, California, United States (enrolling)
• UCSF Medical Center-Mission Bay — San Francisco, California, United States (enrolling)
• Heartland Oncology and Hematology LLP — Council Bluffs, Iowa, United States (enrolling)
• University of Kentucky/Markey Cancer Center — Lexington, Kentucky, United States (enrolling)

Full record on ClinicalTrials.gov

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