Diagnostic Trial in Patients Who Are Undergoing Surgery for Early Stage Mouth Cancer
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.
Head and Neck Cancer
Other: immunohistochemistry staining method
Procedure: conventional surgery
Procedure: radionuclide imaging
Procedure: sentinel lymph node biopsy
Radiation: technetium Tc 99m sulfur colloid
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||A Trial Of Lymphatic Mapping And Sentinel Node Lymphadenectomy For Patients With T1 or T2 Clinically N0 Oral Cavity Squamous Cell Carcinoma|
- Proportion of non-SLN(s) negative patients [ Time Frame: Up to 30 days ] [ Designated as safety issue: No ]
|Study Start Date:||May 2002|
|Study Completion Date:||November 2010|
|Primary Completion Date:||May 2007 (Final data collection date for primary outcome measure)|
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.
|Other: immunohistochemistry staining method Procedure: conventional surgery Procedure: lymphangiography Procedure: radionuclide imaging Procedure: sentinel lymph node biopsy Radiation: technetium Tc 99m sulfur colloid|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00042926
|Study Chair:||Francisco Civantos, MD||University of Miami Sylvester Comprehensive Cancer Center|