Diagnostic Trial in Patients Who Are Undergoing Surgery for Early Stage Mouth Cancer

OBJECTIVES:

• Determine whether a negative hematoxylin and eosin finding from the lymphatic mapping and sentinel node lymphadenectomy procedure accurately predicts the negativity of the other cervical lymph nodes in patients with stage I or II squamous cell carcinoma of the oral cavity.
• Determine the extent and pattern of disease spread in the nodal bed in these patients.
• Obtain data on the use of immunohistochemistry to assess nodes in these patients.

Inclusion criteria

• Patient must be > 18 years of age.
• Patient must have an ECOG/Zubrod performance status of < 2.
• Patient must have a histologically confirmed primary T1 or T2 invasive OCSCCA that is > 6mm and < 4 cm in size. The primary tumor must be amenable to curative resection and must be diagnosed within 42 days prior to surgery.
• Patient must be clinically stage N0 confirmed with a negative imaging study employing contrastenhanced CT scan (or MRI with gadolinium in patients with iodine allergy). Lymph nodes will be considered positive if:

• Greater than 1.5 cm in size for levels I and II.
• Greater than 1 cm in size for levels III, IV, V and VI.
• If any lymph node exhibits central necrosis, irregular enhancement of a poorly defined or irregular capsular border.
• Groups of three or more asymmetrically located LNs, with a minimal axial diameter of 8 mm or more, in the suspected tumor drainage area are present.
• NOTE: All CT scans must be read by a neuroradiologist.
• Patient must be medically fit for neck dissection.
• Patient or the patient's legally acceptable representative must provide a signed and dated written informed consent prior to registration or any study-related procedures.
• Female patient of childbearing potential must have negative serum pregnancy test within 30 daysprior to registration.
• If the patient is a survivor of a prior cancer, ALL of the following criteria are met:

• Patient has undergone potentially curative therapy for all prior malignancies,
• No evidence of any prior malignancies for at least 5 years with no evidence of recurrence (except for effectively treated basal cell or squamous carcinoma of the skin, carcinoma in-situ of the cervix that has been effectively treated by surgery alone, or lobular carcinoma in-situ of the ipsilateral or contralateral breast treated by surgery alone),
• Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies.

Exclusion criteria

• Patient received prior treatment to the cervical lymph nodes, including surgery or radiation therapy.
• Patient experienced prior extensive trauma to the anterior cervical region of the neck.
• Patient has lesions that cross the vermilion border involving lip skin.
• Patient has had previous tumor resection involving the neck.
• Patient has had injections of radioactive material for previous scans within 48 hours of the radiolymphoscintigraphy.