Diagnostic Trial in Patients Who Are Undergoing Surgery for Early Stage Mouth Cancer
Head and Neck Cancer
About this trial
This is an interventional diagnostic trial for Head and Neck Cancer focused on measuring stage I squamous cell carcinoma of the lip and oral cavity, stage II squamous cell carcinoma of the lip and oral cavity
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Experimental
Radiolymphoscintigraphy + surgery
Patients undergo radiolymphoscintigraphy comprising technetium Tc 99m sulfur colloid to identify the sentinel lymph nodes (SNL). Within 18 hours after radiolymphoscintigraphy, patients undergo resection of the primary oral cavity tumor and radioguided sentinel lymphadenectomy and regional cervical lymphadenectomy. Lymph nodes are examined by hematoxylin and eosin (H&E) staining. If negative by H&E, lymph nodes are further analyzed by immunohistochemistry. Patients are followed at 30 days.