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

Conditions

• 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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Chest Radiography — PROCEDURE
  Undergo chest x-ray
• Computed Tomography — PROCEDURE
  Undergo SPECT/CT scan and FDG PET/CT or CT
• Fludeoxyglucose F-18 — OTHER
  Undergo FDG PET/CT
• Imaging Agent — DRUG
  Receive imaging agent via injection
• Neck Dissection — PROCEDURE
  Undergo standard elective neck dissection
• Planar Imaging — PROCEDURE
  Undergo planar imaging
• Positron Emission Tomography — PROCEDURE
  Undergo FDG PET/CT
• Questionnaire Administration — OTHER
  Ancillary studies
• Sentinel Lymph Node Biopsy — PROCEDURE
  Undergo SLN biopsy
• Single Photon Emission Computed Tomography — PROCEDURE
  Undergo SPECT/CT scan

Study Details

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 Dates

Start date

Sep 23, 2020

Status verified

Apr 2026

Primary completion

Apr 27, 2031

Completion

Apr 27, 2031

Study Design

Enrollment

686 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Patient-reported neck and shoulder function (Phase II/III) [ Time Frame: Before surgery (Baseline), 3 weeks after surgery, 3, 6, 12 months after surgery ]

Locations (105)

Find similar trials in Birmingham, AL

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