Trials / Completed
CompletedNCT00042926
Diagnostic Trial in Patients Who Are Undergoing Surgery for Early Stage Mouth Cancer
A Trial Of Lymphatic Mapping And Sentinel Node Lymphadenectomy For Patients With T1 or T2 Clinically N0 Oral Cavity Squamous Cell Carcinoma
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 161 (actual)
- Sponsor
- Alliance for Clinical Trials in Oncology · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | immunohistochemistry staining method | |
| PROCEDURE | conventional surgery | |
| PROCEDURE | lymphangiography | |
| PROCEDURE | radionuclide imaging | |
| PROCEDURE | sentinel lymph node biopsy | |
| RADIATION | technetium Tc 99m sulfur colloid |
Timeline
- Start date
- 2002-05-01
- Primary completion
- 2007-05-01
- Completion
- 2010-11-01
- First posted
- 2003-01-27
- Last updated
- 2016-12-07
Source: ClinicalTrials.gov record NCT00042926. Inclusion in this directory is not an endorsement.