A Trial Of Lymphatic Mapping And Sentinel Node Lymphadenectomy For Patients With T1 Or T2 Clinically N0 Oral Cavity Squamous Cell Carcinoma
- 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.
OUTLINE: This is a multicenter study.
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
Patients are followed at 30 days.
PROJECTED ACCRUAL: A total of 161 patients will be accrued for this study within 2.7 years.
Masking: Open Label, Primary Purpose: Diagnostic
Francisco Civantos, MD
University of Miami Sylvester Comprehensive Cancer Center
United States: Federal Government