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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000069485 | Registry Identifier | NCI Physician Data Query |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiolymphoscintigraphy + surgery | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| immunohistochemistry staining method | Other |
| ||
| conventional surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of non-SLN(s) negative patients | Up to 30 days |
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Inclusion Criteria:
Patient must be > 18 years of age.
Patient must have an ECOG/Zubrod performance status of < 2.
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:
Patient must be medically fit for neck dissection.
Patient or the patient's legally acceptable representative must provide a signed and dated written informed consent prior to registration or any study-related procedures.
Female patient of childbearing potential must have negative serum pregnancy test within 30 daysprior to registration.
If the patient is a survivor of a prior cancer, ALL of the following criteria are met:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francisco Civantos, MD | University of Miami Sylvester Comprehensive Cancer Center | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20142602 | Result | Civantos FJ, Zitsch RP, Schuller DE, Agrawal A, Smith RB, Nason R, Petruzelli G, Gourin CG, Wong RJ, Ferris RL, El Naggar A, Ridge JA, Paniello RC, Owzar K, McCall L, Chepeha DB, Yarbrough WG, Myers JN. Sentinel lymph node biopsy accurately stages the regional lymph nodes for T1-T2 oral squamous cell carcinomas: results of a prospective multi-institutional trial. J Clin Oncol. 2010 Mar 10;28(8):1395-400. doi: 10.1200/JCO.2008.20.8777. Epub 2010 Feb 8. |
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| Procedure |
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| lymphangiography | Procedure |
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| radionuclide imaging | Procedure |
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| sentinel lymph node biopsy | Procedure |
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| technetium Tc 99m sulfur colloid | Radiation |
|
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D007150 | Immunohistochemistry |
| D021701 | Sentinel Lymph Node Biopsy |
| D013671 | Technetium Tc 99m Sulfur Colloid |
| ID | Term |
|---|---|
| D006651 | Histocytochemistry |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006652 | Histological Techniques |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008197 | Lymph Node Excision |
| D013457 | Sulfur Compounds |
| D007287 | Inorganic Chemicals |
| D017556 | Technetium Compounds |
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