Diagnostic Trial in Patients Who Are Undergoing Surgery for Early Stage Mouth Cancer
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|ClinicalTrials.gov Identifier: NCT00042926|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 7, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Other: immunohistochemistry staining method Procedure: conventional surgery Procedure: lymphangiography Procedure: radionuclide imaging Procedure: sentinel lymph node biopsy Radiation: technetium Tc 99m sulfur colloid||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||161 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Trial Of Lymphatic Mapping And Sentinel Node Lymphadenectomy For Patients With T1 or T2 Clinically N0 Oral Cavity Squamous Cell Carcinoma|
|Study Start Date :||May 2002|
|Actual Primary Completion Date :||May 2007|
|Actual Study Completion Date :||November 2010|
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: radionuclide imaging
Procedure: sentinel lymph node biopsy
Radiation: technetium Tc 99m sulfur colloid
- Proportion of non-SLN(s) negative patients [ Time Frame: Up to 30 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00042926
|Study Chair:||Francisco Civantos, MD||University of Miami Sylvester Comprehensive Cancer Center|