A Trial Of Lymphatic Mapping And Sentinel Node Lymphadenectomy For Patients With T1 or T2 Clinically N0 Oral Cavity Squamous Cell Carcinoma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Head and Neck Cancer
- Sponsor
- Alliance for Clinical Trials in Oncology
- Enrollment
- 161
- Primary Endpoint
- Proportion of non-SLN(s) negative patients
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
RATIONALE: Diagnostic procedures to detect cancer cells in sentinel lymph nodes may help plan effective cancer treatment.
PURPOSE: Diagnostic trial to study the effectiveness of lymph node mapping and sentinel lymph node lymphadenectomy in patients who are undergoing surgery to remove early-stage cancer of the mouth.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient must be \> 18 years of age.
- •Patient must have an ECOG/Zubrod performance status of \<
- •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.
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.
Outcomes
Primary Outcomes
Proportion of non-SLN(s) negative patients
Time Frame: Up to 30 days