RecruitingBuccal Mucosa Squamous Cell CarcinomaFloor of Mouth Squamous Cell CarcinomaGingival Squamous Cell Carcinoma

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

Eligible age

18+ yrs

Accepts

All genders

Locations

32 states

Healthy volunteers

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About this study

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.

Sponsor: NRG Oncology

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)

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