Comparing Sentinel Lymph Node Biopsy with Neck Dissection for Early Oral Cavity Cancer
This study is comparing two surgical approaches for early-stage oral cavity (mouth) cancer: sentinel lymph node (SLN) biopsy and standard neck dissection. SLN biopsy is a procedure where doctors use an imaging agent to find and remove only the lymph nodes most likely to contain cancer. Standard neck dissection removes many more lymph nodes. Researchers want to see if SLN biopsy leads to better neck and shoulder function and quality of life for patients, and if it is as effective in preventing cancer recurrence as standard neck dissection. You may be eligible if you are 18 or older and have a confirmed diagnosis of early-stage squamous cell carcinoma of the oral cavity. The study is currently recruiting 686 participants, but its overall status is unclear.
- Study design
- This is a Phase II/III interventional study comparing two surgical methods for early-stage oral cavity cancer, aiming to enroll 686 participants.
- What's involved
- You would undergo procedures like chest x-rays, CT scans, and potentially FDG PET/CT scans. You would also receive an imaging agent injection and undergo either sentinel lymph node biopsy or neck dissection surgery. Your neck and shoulder function and quality of life would be measured at several points up to 12 months after surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your disease-free survival will be assessed for up to 11 years after randomization.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04333537
Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection for Patients With Early-Stage Oral Cavity Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentNRG OncologyInvestigator-initiated
~686 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:Chest RadiographyComputed TomographyFludeoxyglucose F-18Imaging AgentNeck DissectionPlanar Imaging
At a glance
Recruiting sites
88 of 107 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Patient-reported neck and shoulder function (Phase II/III)
Measured over Before surgery (Baseline), 3 weeks after surgery, 3, 6, 12 months after surgery
+2 more outcomes measured
Conditions
Where it's being run
107 sites across 33 statesPennsylvania13
New York11
California7
Texas7
Michigan6
New Jersey5
Wisconsin5
Arizona4
Study leadership
- Stephen Y Lai · PRINCIPAL_INVESTIGATOR · NRG Oncology
Who to contact
Site Public Contact
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
Exclusion
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
What this trial measures
- Patient-reported neck and shoulder function (Phase II/III)Before surgery (Baseline), 3 weeks after surgery, 3, 6, 12 months after surgery
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.
- Patient reported quality of life (QOL) (Phase II)Before surgery (Baseline), 3 weeks after surgery, 3, 6, 12 months after surgery
Will be measured using 3 questionnaires over 12-15 minutes.
- Disease-free survival (DFS) (phase III)From randomization to local/regional recurrence, distant metastasis, or death due to any cause, whichever comes first, assessed up to 11 years
Measured using Cox proportional hazards model and the Kaplan-Meier method. Failure includes local/regional recurrence, distant metastasis, or death due to any cause.