Health Trials

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

ConditionsBuccal Mucosa Squamous Cell CarcinomaFloor of Mouth Squamous Cell CarcinomaGingival Squamous Cell CarcinomaHard Palate Squamous Cell CarcinomaLip Squamous Cell CarcinomaLower Alveolar Ridge Squamous Cell CarcinomaOral Cavity Squamous Cell CarcinomaRetromolar Trigone Squamous Cell CarcinomaStage I Lip and Oral Cavity Cancer AJCC v8Stage II Lip and Oral Cavity Cancer AJCC v8Tongue Squamous Cell CarcinomaUpper Alveolar Ridge Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNRG Oncology

About this trial

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.

Eligibility criteria

Qualifiers

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

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Chest Radiography
  • Computed Tomography
  • Fludeoxyglucose F-18
  • Imaging Agent
  • Neck Dissection
  • Planar Imaging
  • Positron Emission Tomography
  • Questionnaire Administration
  • Sentinel Lymph Node Biopsy
  • Single Photon Emission Computed Tomography

Treatment groups

686 Participants
are divided into 2 treatment groups

Sponsors and collaborators

NRG Oncology

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov